Method and composition for treating nail psoriasis

Abstract

The present disclosure relates to a method for treating nail psoriasis in a subject, comprising the step of administering a therapeutically effective amount of the anti-IL-23p19 antibody hum13B8-b to said subject. The present disclosure also relates to a method for improving one or more of the following in a subject with nail psoriasis by administering a therapeutically effective amount of the anti-IL-23p19 antibody hum13B8-b to said subject: the Total-Varied Nail Psoriasis Severity Index (mNAPSI), the Visual Medical Scale for Evaluating Nail Psoriasis Severity (ViSENPsO) score, the Total Nail Psoriasis Severity Index (NAPSI), the Nail Pain Rating Scale (NRS) score, the Varied Nail Psoriasis Severity Index (mNAPSI), the Nail Psoriasis Severity Index (NAPSI), the Visual Medical Scale for Evaluating Nail Psoriasis Severity (ViSENPsO), or the Nail Pain Rating Scale (NRS) score by administering the therapeutically effective amount of the anti-IL-23p19 antibody hum13B8-b to said subject. The present disclosure further relates to a method for increasing the quality of life (QoL) in subjects with onychomycosis by administering a therapeutically effective amount of the anti-IL-23p19 antibody hum13B8-b to a subject. The present disclosure further relates to a pharmaceutical composition of the anti-IL-23p19 antibody hum13B8-b for treating onychomycosis in subjects. The present disclosure further relates to the use of the anti-IL-23p19 antibody hum13B8-b in manufacturing a medicine for treating onychomycosis in subjects.

Description

Technology Field

[0001] Cross-reference regarding related applications

[0002] This application claims the benefit of Indian Application No. 202321083256 filed on December 6, 2023, the entire disclosure of which is incorporated herein by reference.

[0003] Sequence list

[0004] The present application comprises a sequence list submitted electronically, the entirety of which is incorporated herein by reference. The sequence list submitted with the present application is contained in an XML file created on December 5, 2024, named "23-1517-WO_Sequence-Listing.xml", the size of which is 8,461 bytes.

[0005] Technology field

[0006] The present disclosure relates to a method for treating nail psoriasis in a subject, comprising the step of administering a therapeutically effective amount of the anti-IL-23p19 antibody hum13B8-b to said subject. The present disclosure also relates to a method for improving one or more of the following in a subject with nail psoriasis by administering a therapeutically effective amount of the anti-IL-23p19 antibody hum13B8-b to said subject: the Total-Varied Nail Psoriasis Severity Index (mNAPSI), the Visual Medical Scale for Evaluating Nail Psoriasis Severity (ViSENPsO) score, the Total Nail Psoriasis Severity Index (NAPSI), the Nail Pain Rating Scale (NRS) score, the Varied Nail Psoriasis Severity Index (mNAPSI), the Nail Psoriasis Severity Index (NAPSI), the Visual Medical Scale for Evaluating Nail Psoriasis Severity (ViSENPsO), or the Nail Pain Rating Scale (NRS) score by administering the therapeutically effective amount of the anti-IL-23p19 antibody hum13B8-b to said subject. The present disclosure further relates to a method for increasing the quality of life (QoL) in subjects with onychomycosis by administering a therapeutically effective amount of the anti-IL-23p19 antibody hum13B8-b to a subject. The present disclosure further relates to a pharmaceutical composition of the anti-IL-23p19 antibody hum13B8-b for treating onychomycosis in subjects. The present disclosure further relates to the use of the anti-IL-23p19 antibody hum13B8-b in manufacturing a medicine for treating onychomycosis in subjects. Background Technology

[0007] Psoriasis is a chronic inflammatory skin disorder affecting about 1% to 2% of the world's population. Currently approved biological therapies for moderate to severe plaque psoriasis include tumor necrosis factor (TNF) antagonists, p40 (interleukin [IL]-12 and IL-23) antagonists, p19 (IL-23) antagonists, and IL-17 antagonists.

[0008] Recent clinical trials have demonstrated that IL-23-dependent T-helper (Th)17 cells regulate a significant portion of the inflammatory damage observed in psoriasis. Based on this theoretical basis, several therapeutic anti-IL-23 antibodies have been developed and entered clinical trials. Tildrakizumab, an anti-IL-23p19 antibody, demonstrates efficacy similar to other biological compounds targeting the IL-23 pathway in the treatment of psoriasis. It possesses a favorable safety profile and offers convenient dosing regimens at weeks 0, 4, and every 12 weeks thereafter.

[0009] Tildrakizumab was approved in the United States as ILUMYA for the treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy, and in Australia for the treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy.

[0010] Onychomycosis occurs in approximately 50% of patients with plaque psoriasis and is associated with pain and discomfort, causing a significant burden on quality of life (QoL) and work function. Onychomycosis affects the nail matrix and the nail bed. Clinical signs of psoriasis of the nail matrix include pinpoint depressions (the most common lesions), nail plate flaking, and sucrose, while clinical signs of psoriasis of the nail bed include oil-drop or salmon-pattern dyspigmentation, onycholysis, subungual hyperkeratosis, and the presence of small hemorrhages. Treatment options include topical agents, phototherapy, and / or systemic agents (conventional agents and biological therapies).

[0011] Biological therapy is recommended for the treatment of patients with moderate to severe chronic plaque psoriasis who are candidates for phototherapy or systemic therapy. Currently approved biological agents for moderate to severe plaque psoriasis include tumor necrosis factor (TNF) antagonists, namely etanercept (Enbrel®), infliximab (Remicade®), and adalimumab (Humira®), as well as the p40 (IL-12 and IL-23) antagonist ustekinumab (Stelara®). Despite the availability of treatment options for plaque psoriasis, nail lesions remain difficult to treat due to known low patient satisfaction and adherence to topical therapy. The use of topical therapy, which is generally the primary treatment for plaque psoriasis, is often challenging due to poor spread into nail tissue.

[0012] Over the past few years, accumulated data has revealed that the IL-23 / Th17 pathway is involved in the pathogenesis of psoriasis. Recent genome-wide association studies have identified psoriasis risk alleles around gene regions encoding IL-23 (IL23A, IL12B) and the IL-23 receptor (IL-23R). Both the p19 and p40 subunits of IL-23 are overexpressed in psoriatic skin lesions, whereas the unique p35 subunit of IL-12 is not overexpressed. Th17 cells and the cytokines they produce are abundant in psoriatic lesions, where they exert pro-inflammatory and epidermal thickening-promoting effects. Convincing evidence regarding the functional role of IL-23p19 in psoriasis is demonstrated by a xenograft mouse model of psoriasis using AGR-129 mice, where administration of anti-human IL-23p19 suppressed the development of psoriatic lesions similarly to anti-TNF-α blockers, the current benchmark for psoriasis treatment. Disease improvement with anti-TNF-α therapy correlates with the rapid downregulation of IL-23 and Th17 cellular products, and a successful response to treatment has been shown to depend on the inactivation of the IL-23 / Th17 pathway. Therefore, although the use of IL-12 / IL-23 p40 antagonists (e.g., ustekinumab and briakinumab) has been clinically validated in psoriasis, recent data suggest that the efficacy of these antagonists may depend primarily, but not exclusively, on their ability to neutralize IL-23 rather than IL-12. This provides a theoretical basis for the selective targeting of IL-23p19 in subjects with nail psoriasis. Therefore, the need for effective treatment options for nail psoriasis remains unmet.

[0013] The present disclosure relates to a method for treating nail psoriasis. The present disclosure also relates to a method for improving the index of nail psoriasis through the administration of a humanized IL-23p19 IgG1 / K antibody. The present disclosure further relates to a pharmaceutical composition of an anti-IL-23p19 antibody for treating nail psoriasis in subjects. The present disclosure further relates to the use of an anti-IL-23p19 antibody in manufacturing a medicine for treating nail psoriasis in subjects.

[0014] More specifically, the present disclosure relates to a method for treating nail psoriasis in a subject, comprising the step of administering a therapeutically effective amount of the anti-IL-23p19 antibody hum13B8-b to said subject. The present disclosure also relates to a method for improving one or more of the Total-Varied Nail Psoriasis Severity Index (mNAPSI), Visual Medical Scale for Evaluating Nail Psoriasis Severity (ViSENPsO) score, Total Nail Psoriasis Severity Index (NAPSI), Nail Pain Rating Scale (NRS) score, Varied Nail Psoriasis Severity Index (mNAPSI), Nail Psoriasis Severity Index (NAPSI), Visual Medical Scale for Evaluating Nail Psoriasis Severity (ViSENPsO), or Nail Pain Rating Scale (NRS) score in a subject with nail psoriasis by administering a therapeutically effective amount of the anti-IL-23p19 antibody hum13B8-b to said subject. The present disclosure further relates to a method for increasing the quality of life (QoL) in subjects with onychomycosis by administering a therapeutically effective amount of the anti-IL-23p19 antibody hum13B8-b to a subject. The present disclosure further relates to a pharmaceutical composition of the anti-IL-23p19 antibody hum13B8-b for treating onychomycosis in subjects. The present disclosure further relates to the use of the anti-IL-23p19 antibody hum13B8-b in manufacturing a medicine for treating onychomycosis in subjects.

[0015] A method for treating nail psoriasis is provided at this institution to a subject who requires it, and the method comprises the step of administering a therapeutically effective amount of the anti-IL-23p19 antibody hum13B8-b to the subject, wherein a first dose of hum13B8-b is administered to the subject at week 0, a second dose of hum13B8-b is administered to the subject at approximately week 4 after the first dose is administered to the subject, subsequent doses of hum13B8-b are administered to the subject at approximately week 16 after the first dose is administered to the subject and thereafter at approximately every 12 weeks, and a final dose of hum13B8-b is administered to the subject at approximately week 52 after the first dose is administered to the subject, wherein hum13B8-b comprises a light chain polypeptide comprising the amino acid sequence of SEQ ID NO. 1; and a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO. 2.

[0016] Additionally, the present invention provides a method for improving one or more of (a) the total-modified onysoriasis severity index (mNAPSI), (b) the ViSENPsO scale for assessing onysoriasis severity score, and / or (c) the total onysoriasis severity index (NAPSI) in subjects with onysoriasis, said method comprising the step of administering a therapeutically effective dose of the anti-IL-23p19 antibody hum13B8-b to the subject, wherein a first dose of hum13B8-b is administered to the subject at week 0, a second dose of hum13B8-b is administered to the subject approximately 4 weeks after the first dose is administered to the subject, subsequent doses of hum13B8-b are administered to the subject approximately 16 weeks after the first dose is administered to the subject and thereafter every approximately 12 weeks, and a final dose is administered to the subject approximately 52 weeks after the first dose is administered to the subject, wherein hum13B8-b is, It includes a light chain polypeptide comprising the amino acid sequence of SEQ ID NO. 1; and a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO. 2.

[0017] Also provided herein is a method for improving the nail pain numerical rating scale (NRS) score in subjects with nail psoriasis, said method comprising the step of administering a therapeutically effective amount of the anti-IL-23p19 antibody hum13B8-b to a subject, wherein a first dose of hum13B8-b is administered to the subject at week 0, a second dose of hum13B8-b is administered to the subject at approximately week 4 after the first dose is administered to the subject, subsequent doses of hum13B8-b are administered to the subject at approximately week 16 after the first dose is administered to the subject and thereafter at approximately every 12 weeks, and a final dose is administered to the subject at approximately week 52 after the first dose is administered to the subject, wherein hum13B8-b comprises a light chain polypeptide comprising the amino acid sequence of SEQ ID NO. 1; and a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO. 2.

[0018] In addition, in subjects with onychomycosis, (a) modified onychomycosis severity index (mNAPSI); (b) onychomycosis severity index (NAPSI); (c) visual medical scale for evaluating onychomycosis severity (ViSENPsO); and / or (d) a method for improving one or more of the nail pain numerical rating scale (NRS) scores is provided herein, the method comprising the step of administering a therapeutically effective amount of the anti-IL-23p19 antibody hum13B8-b to a subject, wherein a first dose of hum13B8-b is administered to the subject at week 0, a second dose of hum13B8-b is administered to the subject at approximately week 4 after the first dose is administered to the subject, subsequent doses of hum13B8-b are administered to the subject at approximately week 16 after the first dose is administered to the subject and thereafter at approximately every 12 weeks, and a final dose is administered to the subject at approximately week 52 after the first dose is administered to the subject, wherein hum13B8-b comprises a light chain polypeptide comprising the amino acid sequence of SEQ ID NO. 1; and a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO. 2.

[0019] In addition, in subjects with onychomycosis, (a) modified onychomycosis severity index (mNAPSI); (b) onychomycosis severity index (NAPSI); (c) visual medical scale for evaluating onychomycosis severity (ViSENPsO); and / or (d) a method for improving one or more of the nail pain numerical rating scale (NRS) scores is provided herein, the method comprising the step of administering a therapeutically effective amount of the anti-IL-23p19 antibody hum13B8-b to a subject, wherein a first dose of hum13B8-b is administered to the subject at week 0, a second dose of hum13B8-b is administered to the subject at approximately week 4 after the first dose is administered to the subject, subsequent doses of hum13B8-b are administered to the subject at approximately week 16 after the first dose is administered to the subject and thereafter at approximately every 12 weeks, and a final dose is administered to the subject at approximately week 52 after the first dose is administered to the subject, wherein hum13B8-b comprises a light chain polypeptide comprising the amino acid sequence of SEQ ID NO. 1; and a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO. 2.

[0020] Additionally, a method for increasing the quality of life (QoL) in subjects with nail psoriasis is provided herein, the method comprising the step of administering a therapeutically effective amount of the anti-IL-23p19 antibody hum13B8-b to a subject, wherein a first dose of hum13B8-b is administered to the subject at week 0, a second dose of hum13B8-b is administered to the subject at approximately week 4 after the first dose is administered to the subject, subsequent doses of hum13B8-b are administered to the subject at approximately week 16 after the first dose is administered to the subject and thereafter at approximately every 12 weeks, and a final dose is administered to the subject at approximately week 52 after the first dose is administered to the subject, wherein hum13B8-b comprises a light chain polypeptide comprising the amino acid sequence of SEQ ID NO. 1; and a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO. 2.

[0021] Additionally, a pharmaceutical composition of the anti-IL-23p19 antibody hum13B8-b for the treatment of nail psoriasis in a subject is provided herein, wherein a first dose of the pharmaceutical composition is administered to the subject at week 0, a second dose of the pharmaceutical composition is administered to the subject at approximately week 4 after the first dose is administered to the subject, subsequent doses of the pharmaceutical composition are administered to the subject at approximately week 16 after the first dose is administered to the subject and thereafter at approximately every 12 weeks, and a final dose of the pharmaceutical composition is administered to the subject at approximately week 52 after the first dose is administered to the subject, wherein hum13B8-b comprises a light chain polypeptide comprising the amino acid sequence of SEQ ID NO. 1; and a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO. 2.

[0022] In addition, in subjects with onychomycosis, (a) the total modified onychomycosis severity index (mNAPSI); (b) the onychomycosis severity scale (ViSENPsO) score; and / or (c) a pharmaceutical composition of an anti-IL-23p19 antibody hum13B8-b for improving one or more of the Total Nail Psoriasis Severity Index (NAPSI) is provided herein, wherein a first dose of the pharmaceutical composition is administered to a subject at week 0, a second dose of the pharmaceutical composition is administered to a subject at approximately week 4 after the first dose is administered to the subject, subsequent doses of the pharmaceutical composition are administered to a subject at approximately week 16 after the first dose is administered to the subject and thereafter at approximately every 12 weeks, and a final dose of the pharmaceutical composition is administered to a subject at approximately week 52 after the first dose is administered to the subject, wherein hum13B8-b comprises a light chain polypeptide comprising the amino acid sequence of SEQ ID NO. 1; and a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO. 2.

[0023] Additionally, a pharmaceutical composition of the anti-IL-23p19 antibody hum13B8-b for improving the nail pain numerical rating scale (NRS) score in subjects with nail psoriasis is provided herein, wherein a first dose of the pharmaceutical composition is administered to a subject at week 0, a second dose of the pharmaceutical composition is administered to a subject at approximately week 4 after the first dose is administered to the subject, subsequent doses of the pharmaceutical composition are administered to a subject at approximately week 16 after the first dose is administered to the subject and thereafter at approximately every 12 weeks, and a final dose of the pharmaceutical composition is administered to a subject at approximately week 52 after the first dose is administered to the subject, wherein hum13B8-b comprises a light chain polypeptide comprising the amino acid sequence of SEQ ID NO. 1; and a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO. 2.

[0024] In addition, in subjects with onychomycosis, (a) the modified onychomycosis severity index (mNAPSI); (b) the onychomycosis severity index (NAPSI); (c) the visual medical scale for assessing onychomycosis severity (ViSENPsO); and / or (d) a pharmaceutical composition of an anti-IL-23p19 antibody hum13B8-b for improving one or more of the nail pain numerical rating scale (NRS) scores is provided herein, wherein a first dose of the pharmaceutical composition is administered to a subject at week 0, a second dose of the pharmaceutical composition is administered to a subject at approximately week 4 after the first dose is administered to the subject, subsequent doses of the pharmaceutical composition are administered to a subject at approximately week 16 after the first dose is administered to the subject and thereafter at approximately every 12 weeks, and a final dose of the pharmaceutical composition is administered to a subject at approximately week 52 after the first dose is administered to the subject, wherein hum13B8-b comprises a light chain polypeptide comprising the amino acid sequence of SEQ ID NO. 1; and a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO. 2.

[0025] Additionally, a pharmaceutical composition of the anti-IL-23p19 antibody hum13B8-b for increasing the quality of life (QoL) in subjects with nail psoriasis is provided herein, wherein a first dose of the pharmaceutical composition is administered to a subject at week 0, a second dose of the pharmaceutical composition is administered to a subject at approximately week 4 after the first dose is administered to the subject, subsequent doses of the pharmaceutical composition are administered to a subject at approximately week 16 after the first dose is administered to the subject and thereafter at approximately every 12 weeks, and a final dose of the pharmaceutical composition is administered to a subject at approximately week 52 after the first dose is administered to the subject, wherein hum13B8-b comprises a light chain polypeptide comprising the amino acid sequence of SEQ ID NO. 1; and a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO. 2.

[0026] Additionally, the use of the anti-IL-23p19 antibody hum13B8-b for the manufacture of a medicine for treating nail psoriasis in a subject is provided herein, wherein a first dose of the medicine is administered to the subject at week 0, a second dose of the medicine is administered to the subject at approximately week 4 after the first dose is administered to the subject, subsequent doses of the medicine are administered to the subject at approximately week 16 after the first dose is administered to the subject and thereafter at approximately every 12 weeks, and a final dose of the medicine is administered to the subject at approximately week 52 after the first dose is administered to the subject, wherein hum13B8-b comprises a light chain polypeptide comprising the amino acid sequence of SEQ ID NO. 1; and a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO. 2.

[0027] In addition, in subjects with onychomycosis, (a) the total-modified onychomycosis severity index (mNAPSI); (b) the Visual Medical Scale for Onychomycosis Severity (ViSENPsO) score; and / or (c) the use of the anti-IL-23p19 antibody hum13B8-b for the manufacture of a medicine for improving one or more of the Total Nail Psoriasis Severity Index (NAPSI), wherein a first dose of the medicine is administered to a subject at week 0, a second dose of the medicine is administered to a subject at approximately week 4 after the first dose is administered to the subject, subsequent doses of the medicine are administered to a subject at approximately week 16 after the first dose is administered to the subject and thereafter at approximately every 12 weeks, and a final dose of the medicine is administered to a subject at approximately week 52 after the first dose is administered to the subject, wherein hum13B8-b comprises a light chain polypeptide comprising the amino acid sequence of SEQ ID NO. 1; and a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO. 2.

[0028] Additionally, the use of the anti-IL-23p19 antibody hum13B8-b for the manufacture of a medicine to improve the nail pain numerical rating scale (NRS) score in subjects with nail psoriasis is provided herein, wherein a first dose of the medicine is administered to the subject at week 0, a second dose of the medicine is administered to the subject at approximately week 4 after the first dose is administered to the subject, subsequent doses of the medicine are administered to the subject at approximately week 16 after the first dose is administered to the subject and thereafter at approximately every 12 weeks, and a final dose of the medicine is administered to the subject at approximately week 52 after the first dose is administered to the subject, wherein hum13B8-b comprises a light chain polypeptide comprising the amino acid sequence of SEQ ID NO. 1; and a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO. 2.

[0029] In addition, in subjects with onychomycosis, (a) the modified onychomycosis severity index (mNAPSI); (b) the onychomycosis severity index (NAPSI); (c) the visual medical scale for assessing onychomycosis severity (ViSENPsO); and / or (d) the use of the anti-IL-23p19 antibody hum13B8-b for the manufacture of a medicine for improving one or more of the nail pain numerical rating scale (NRS) scores is provided herein, wherein a first dose of the medicine is administered to a subject at week 0, a second dose of the medicine is administered to a subject at approximately week 4 after the first dose is administered to the subject, subsequent doses of the medicine are administered to a subject at approximately week 16 after the first dose is administered to the subject and thereafter at approximately every 12 weeks, and a final dose of the medicine is administered to a subject at approximately week 52 after the first dose is administered to the subject, wherein hum13B8-b comprises a light chain polypeptide comprising the amino acid sequence of SEQ ID NO. 1; and a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO. 2.

[0030] Additionally, the use of the anti-IL-23p19 antibody hum13B8-b for the manufacture of a medicine to increase the quality of life (QoL) in subjects with nail psoriasis is provided herein, wherein a first dose of the medicine is administered to the subject at week 0, a second dose of the medicine is administered to the subject at approximately week 4 after the first dose is administered to the subject, subsequent doses of the medicine are administered to the subject at approximately week 16 after the first dose is administered to the subject and thereafter at approximately every 12 weeks, and a final dose of the medicine is administered to the subject at approximately week 52 after the first dose is administered to the subject, wherein hum13B8-b comprises a light chain polypeptide comprising the amino acid sequence of SEQ ID NO. 1; and a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO. 2.

[0031] These features and advantages of the present disclosure, and other features and advantages, will be more fully understood from the following detailed description taken together with the claims appended herein. It should be noted that the scope of the claims is defined by the items described herein and not by the specific discussion of the features and advantages presented in this specification. Brief explanation of the drawing

[0032] Fig. 1 It illustrates a flowchart showing the overall clinical trial overview for the tildrakizumab clinical trial. Fig. 2 It illustrates a visual picture of the quadrants for evaluating various characteristics of the NAPSI assessment. Fig. 3 It illustrates a visual schematic diagram for grading the severity of nail psoriasis. Fig. 4 It plots a sample of the Quality of Life Index (QOLI). Fig. 5 It illustrates a sample of the Quality of Life (QoL) questionnaire. Specific details for implementing the invention

[0033] The present disclosure relates to a method for treating nail psoriasis. More specifically, the present disclosure relates to a method for improving nail psoriasis as demonstrated by an improvement in clinically acceptable scales of nail psoriasis. In particular, the present disclosure relates to treating nail psoriasis as demonstrated by an improvement in the total-modified nail psoriasis severity index (mNAPSI), the Visual Medical Scale for Assessing Nail Psoriasis Severity (ViSENPsO), the total nail psoriasis severity index (NAPSI), and / or the Nail Pain Numerical Rating Scale (NRS) scores. The present disclosure further relates to a pharmaceutical composition of an anti-IL-23p19 antibody for treating nail psoriasis in subjects. The present disclosure further relates to the use of an anti-IL-23p19 antibody in manufacturing a medicine for treating nail psoriasis in subjects.

[0034] The present disclosure relates to a method for treating nail psoriasis in a subject, comprising the step of administering a therapeutically effective amount of the anti-IL-23p19 antibody hum13B8-b to said subject. The present disclosure also relates to a method for improving one or more of the following in a subject with nail psoriasis by administering a therapeutically effective amount of the anti-IL-23p19 antibody hum13B8-b to said subject: the Total-Varied Nail Psoriasis Severity Index (mNAPSI), the Visual Medical Scale for Evaluating Nail Psoriasis Severity (ViSENPsO) score, the Total Nail Psoriasis Severity Index (NAPSI), the Nail Pain Rating Scale (NRS) score, the Varied Nail Psoriasis Severity Index (mNAPSI), the Nail Psoriasis Severity Index (NAPSI), the Visual Medical Scale for Evaluating Nail Psoriasis Severity (ViSENPsO), or the Nail Pain Rating Scale (NRS) score by administering the therapeutically effective amount of the anti-IL-23p19 antibody hum13B8-b to said subject. The present disclosure further relates to a method for increasing the quality of life (QoL) in subjects with onychomycosis by administering a therapeutically effective amount of the anti-IL-23p19 antibody hum13B8-b to a subject. The present disclosure further relates to a pharmaceutical composition of the anti-IL-23p19 antibody hum13B8-b for treating onychomycosis in subjects. The present disclosure further relates to the use of the anti-IL-23p19 antibody hum13B8-b in manufacturing a medicine for treating onychomycosis in subjects.

[0035] As used in accordance with this disclosure, unless otherwise specified or defined, all technical and scientific terms used herein should be understood to have the meanings commonly understood by those skilled in the art to which this disclosure pertains. The following references provide those skilled in the art with general definitions of many of the terms used in this disclosure: the work of Singleton et al. [Dictionary of Microbiology and Molecular Biology (2nd ed., 1994)]; The Cambridge Dictionary of Science and Technology (edited by Walker, 1988); The Glossary of Genetics, 5th ed., edited by R. Rieger et al., Springer Verlag (1991); and the work of Hale & Marham [The Harper Collins Dictionary of Biology (1991)]. As used herein, the following terms have the meanings described below unless otherwise specified.

[0036] Unless otherwise required by the context, singular terms include the plural form, and plural terms include the singular form. For example, as used herein, the terms “one,” “one,” or “a specific one” should be understood as singular or plural unless the relevant context explicitly indicates otherwise. It should be understood that singular terms used herein (“one” and “one”) refer to “one or more” of the enumerated components unless otherwise indicated or suggested by the context. The use of alternatives (e.g., “or”) should be understood to mean one, both, or any combination thereof of the alternatives, unless otherwise specified. Accordingly, as used herein, the term “or” should be understood inclusively unless specifically stated or evident from the context.

[0037] As used herein, the terms “include” and “include” may have the meanings given to them by U.S. patent law and may mean “include,” “include,” “containing,” “having,” etc. Accordingly, unless otherwise specified, as used herein, the terms “include” and “include” indicate that additional components or members may be optionally present in addition to the components or members listed in the list beginning with the term “include.” As used herein, the terms “essentially constituted” or “to be essentially constituted” likewise have the meanings given to them by U.S. patent law and allow for the existence of more elements than those cited, provided that the basic or novel characteristics of the cited are not altered by the existence of elements beyond those cited.

[0038] Any method provided herein may be combined with one or more of any other methods provided herein. Any composition provided herein may be combined with one or more of any other compositions provided herein. Any use provided herein may be combined with one or more of any other uses provided herein.

[0039] In this disclosure, any concentration range, percentage range, ratio range, or integer range should be understood to include any integer value within the cited range and, where appropriate, fractional values ​​thereof (e.g., 1 / 10 and 1 / 100 of an integer) unless otherwise specified. The ranges provided herein should be understood as abbreviations representing all values ​​within the said range. For example, the range from 1 to 50 should be understood to include any number, combination of numbers, or sub-range from the group consisting of 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, or 50.

[0040] Unless specifically stated or evident from the context, as used herein, the terms “about” and “approximately” mean, for example, within 2 standard deviations of the mean of a specific value determined by a person skilled in the art, or within a tolerance range, or within the nominal tolerance range of the art, and it should be understood that this depends in part on the method by which the value is measured or determined, i.e., the limits of the measurement system. “About” may be understood to mean within 10%, 9%, 8%, 7%, 6%, 5%, 4%, 3%, 2%, 1%, 0.5%, 0.1%, 0.05%, or 0.01% of the said value. Unless otherwise evident from the context, all numerical values ​​provided herein are modified by the term “about.”

[0041] It should be noted that terms such as “preferably,” “generally,” and “typically” are not used herein to limit the scope of the claimed subject matter or to imply that certain features are important, essential, or even important to the structure or function of the claimed subject matter. Rather, these terms are intended merely to highlight alternative features or additional features that may or may not be available in the specific embodiments of this disclosure.

[0042] To describe and define the present disclosure, it is noted that the term “substantially” is used herein to indicate the inherent degree of uncertainty that may be attributed to any quantitative comparison, value, measurement, or other expression. The term “substantially” is also used to indicate the extent to which a quantitative expression may differ from a specified standard without altering the fundamental function of the subject matter of dispute.

[0043] IL-23p19 antibody

[0044] In some embodiments, the present disclosure provides a method for improving the total modified nail psoriasis severity index (mNAPSI) in a subject with nail psoriasis, the method comprising: administering an initial dose of a humanized IL-23p19 IgG1 / K antibody to the subject at baseline (week 0); administering a second dose of the humanized IL-23p19 IgG1 / K antibody to the subject about 4 weeks after the initial dose; and administering additional doses of the humanized IL-23p19 IgG1 / K antibody to the subject about 16 weeks after the initial dose and thereafter at approximately 12 weeks, wherein the final dose is administered to the subject about 52 weeks after the initial dose. In some embodiments, the present disclosure provides a pharmaceutical composition of an anti-IL-23p19 antibody for the treatment of nail psoriasis in a subject. In some embodiments, the present disclosure provides the use of an anti-IL-23p19 antibody for the manufacture of a medicine to treat nail psoriasis in subjects. In a specific embodiment, the anti-IL-23p19 antibody hum13B8-b is tildrakizumab.

[0045] The term "tildrakizumab" as used herein refers to a humanized anti-IL-23p19 monoclonal antibody also known as SCH 900222 or MK-3222. Tildrakizumab is a high-affinity (297 picomolar [pM]) humanized immunoglobulin G1 / kappa (IgG1 / κ) antibody that specifically binds to the p19 protein of IL-23 heterodimers but does not bind to human IL-12 (IL-12 / 23p40 and IL12p35 heterodimers) or human IL-12 / 23p40.

[0046] To date, clinically useful IL-12 / IL-23 p40 antagonists provide benefits in psoriasis by targeting IL-23 rather than IL-12. Based on this knowledge, the inventors of the present disclosure used tildrakizumab in the treatment of nail psoriasis to target only IL-23p19 (SN 08197) and not human IL-12 (IL-12p40 and p35 heteromers) or human p40. As such, the use of tildrakizumab is a novel approach in the treatment of nail psoriasis.

[0047] In a specific embodiment, the anti-IL23p19 antibody hum13B8-b (tildrakizumab) comprises a light chain polypeptide comprising the amino acid sequence of SEQ ID NO. 1 and a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO. 2, as disclosed in U.S. Patents No. 8,404,813 and No. 8,293,883, the entirety of which is incorporated herein by reference. In another embodiment, the anti-IL-23p19 antibody hum13B8-b or its antigen-binding fragment comprises a heavy chain variable domain and a light chain variable domain, wherein the heavy chain variable domain comprises the sequences CDR1, CDR2, and CDR3 of the amino acid sequences of SEQ ID NOs. 3–5, and the light chain variable domain comprises the sequences CDR1, CDR2, and CDR3 of the amino acid sequences of SEQ ID NOs. 6–8:

[0048] Hum13B8-b light chain (sequence number 1)

[0049] DIQMTQSPSSLSASVGDRVTITCRTSENIYSYLAWYQQKPGKAPKLLIYNAKTLAEGVPSRFSGSGSGTDFTLTISSLQPEDFATYYCQHHYGIPFTFGQGTKVEIK RTVAAPSVFIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLSSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC

[0050] Hum13B8-b heavy chain (sequence number 2)

[0051] QVQLVQSGAEVKKPGASVKVSCKASGYIFITYWMTWVRQAPGQGLEWMGQIFPASGSADYNEKFEGRVTMTDTSTSTAYMELRSLRSDDTAVYYCARGGGGFAYWGQGTL VTVSSASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKKVEPKSCDKTH TCPPCPAPELLGGPSVFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPREEQYNSTYRVVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKT ISKAKGQPREPQVYTLPPSRDELTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSRWQQGNVFSCSVMHEALHNHYTQKSLSLSPGK

[0052] Hum13B8-b heavy chain CDR1 (sequence number 3)

[0053] GYIFITYWMT

[0054] Hum13B8-b heavy chain CDR2 (sequence number 4)

[0055] QIFPASGSADYNEKFE

[0056] Hum13B8-b heavy chain CDR3 (sequence number 5)

[0057] GGGGFAY

[0058] Hum13B8-b light chain CDR1 (sequence number 6)

[0059] RTSENIYSYLA

[0060] Hum13B8-b light chain CDR2 (sequence number 7)

[0061] NAKTLAE

[0062] Hum13B8-b light chain CDR3 (sequence number 8)

[0063] QHHYGIPFT

[0064] In some embodiments, the anti-IL-23p19 antibody tildrakizumab may refer to ILUMYA®. In some embodiments, tildrakizumab is formulated into a 1 mL single-dose pre-filled syringe containing 100 mg of tildrakizumab (i.e., 100 mg / mL). In some embodiments, the ILUMYA® (tildrakizumab-asmn) injection for subcutaneous use is a colorless to slightly yellowish sterile solution that is clear to slightly milky white. ILUMYA® is supplied in a single-dose pre-filled syringe equipped with a glass barrel and a 29-gauge fixed 1 / 2-inch needle. In one embodiment, subcutaneous administration is performed at the abdominal site.

[0065] In some embodiments, tildrakizumab may be formulated in water for injection at a pH of 5.7 to 6.3 in L-histidine, L-histidine hydrochloride monohydrate, polysorbate 80, and / or sucrose. In some embodiments, tildrakizumab may be formulated in a 1 mL single-dose pre-filled syringe containing 100 mg of tildrakizumab-asmn formulated in L-histidine (0.495 mg), L-histidine hydrochloride monohydrate (1.42 mg), polysorbate 80 (0.5 mg), sucrose (70.0 mg), and USP water for injection at a pH of 5.7 to 6.3.

[0066] Anti-IL-23p19 antibodies can be administered in a dosage range of 5 to 250 mg. In some embodiments of the present disclosure, about 5 mg, about 10 mg, about 15 mg, about 20 mg, about 25 mg, about 30 mg, about 35 mg, about 40 mg, about 45 mg, about 50 mg, about 55 mg, about 60 mg, about 65 mg, about 70 mg, about 75 mg, about 80 mg, about 85 mg, about 90 mg, about 95 mg, about 100 mg, about 105 mg, about 110 mg, about 115 mg, about 120 mg, about 125 mg, about 130 mg, about 135 mg, about 140 mg, about 145 mg, about 150 mg, about 155 mg, about 160 mg, about 165 mg, about 170 mg, about 175 mg, about 180 mg, about 185 It may be administered in mg, about 190 mg, about 195 mg, about 200 mg, about 205 mg, about 210 mg, about 215 mg, about 220 mg, about 225 mg, about 230 mg, about 235 mg, about 240 mg, about 245 mg, or about 250 mg. In some embodiments of the present disclosure, 25 mg, 50 mg, 75 mg, or 100 mg of an anti-IL-23p19 antibody is administered. In one embodiment of the present disclosure, 100 mg of an anti-IL-23p19 antibody is administered. More specifically, in one embodiment, 100 mg of tildrakizumab is administered.

[0067] As used herein, the terms "subject" and "patient" are used interchangeably. In some embodiments, the subject and / or patient are mammals.

[0068] "Disorder" is any pathological condition that may benefit from treatment using the antibody of the present disclosure. "Disorder" and "pathological condition" are used interchangeably herein and include chronic and acute disorders or diseases, including pathological conditions that make the subject or patient susceptible to the disorder.

[0069] As used herein, the terms "treatment" or "to treat" refer to both therapeutic treatment and preventive or control measures. Those requiring treatment include not only individuals or patients with onychomycosis but also individuals susceptible to onychomycosis or those for whom onychomycosis needs to be prevented.

[0070] As used herein, the term “administration” or “administrating step” refers to providing, contacting, and / or delivering an antibody or a fragment thereof by any appropriate route to achieve the desired effect. Administration may include, but is not limited to, oral, sublingual, parenteral (e.g., intravenous, subcutaneous, intradermal, intramuscular, intra-articular, intra-arterial, intrasynovial, intrasternal, intradural, intralesional, or intracranial injection), percutaneous, local, buccal, rectal, vaginal, nasal, ocular, inhalation, and implantation. In one embodiment, administration is subcutaneous administration via a pre-filled syringe (PFS).

[0071] In some embodiments, the anti-IL-23p19 antibody hum13B8-b or its antigen-binding fragment is administered every 2 weeks, every 4 weeks, every 6 weeks, every 8 weeks, every 10 weeks, or every 12 weeks.

[0072] As used herein, the term "Week 0" refers to the first day on which the anti-IL-23p19 antibody hum13B8-b or its antigen-binding fragment is administered.

[0073] In some embodiments, the anti-IL-23p19 antibody hum13B8-b or its antigen-binding fragment is administered over a treatment period of 2 weeks, over a treatment period of 4 weeks, over a treatment period of 6 weeks, over a treatment period of 8 weeks, over a treatment period of 12 weeks, over a treatment period of 16 weeks, over a treatment period of 20 weeks, over a treatment period of 24 weeks, over a treatment period of 28 weeks, over a treatment period of 32 weeks, over a treatment period of 36 weeks, over a treatment period of 48 weeks, over a treatment period of 52 weeks, over a treatment period of 60 weeks, over a treatment period of 72 weeks, or over a treatment period of 1 year or more.

[0074] The therapeutic dose or therapeutically effective dose of the anti-IL-23p19 antibody hum13B8-b or its antigen-binding fragment will vary in part depending on the size (body weight, body surface area, or organ size) and condition (age and overall health status) of the subject or patient. In some embodiments, one or more doses of the anti-IL-23p19 antibody hum13B8-b or its antigen-binding fragment are administered to the subject or patient, wherein the dose is about 20 mg, 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, 160 mg, 180 mg, or 200 mg. In some embodiments, the first dose, second dose, and subsequent doses of the anti-IL-23p19 antibody hum13B8-b or its antigen-binding fragment are the same. In some embodiments, the first dose, second dose, and subsequent dose of the anti-IL-23p19 antibody hum13B8-b or its antigen-binding fragment are different. In some embodiments, the first dose is 100 mg. In some embodiments, the first dose is 200 mg. In some embodiments, the second dose is 100 mg. In some embodiments, the second dose is 200 mg. In some embodiments, the subsequent dose is 100 mg. In some embodiments, the subsequent dose is 200 mg. In some embodiments, the first dose, second dose, and subsequent dose are 100 mg. In some embodiments, the first dose, second dose, and subsequent dose are 200 mg. In some embodiments, the first dose, second dose, and subsequent dose contain 100 mg of hum13B8-b. In some embodiments, the first dose, the second dose, and the subsequent dose contain 200 mg of hum13B8-b.

[0075] When applied to dosage or amount, the term “therapeutic effective dose” refers to an amount of compound or pharmaceutical composition sufficient to produce a desired effect after administration to a subject requiring it. As used herein in relation to pharmaceutical compositions comprising the anti-IL-23p19 antibody hum13B8-b (i.e., tildrakizumab), the term “therapeutic effective dose” also refers to an amount of compound or pharmaceutical composition sufficient to produce an effective response after administration to a subject. In some embodiments, the therapeutic effective dose of the anti-IL-23p19 antibody hum13B8-b (i.e., tildrakizumab) refers to a dosage of 20 mg, 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, 160 mg, 180 mg, or 200 mg. In some embodiments, the therapeutically effective dose of the anti-IL-23p19 antibody hum13B8-b (i.e., tildrakizumab) is a dose of 100 mg. In some embodiments, the therapeutically effective dose of the anti-IL-23p19 antibody hum13B8-b (i.e., tildrakizumab) is a dose of 100 mg at week 0, week 4, and thereafter every 12 weeks.

[0076] Efficacy evaluation

[0077] Efficacy evaluation functions as an objective measure of the severity and improvement of nail psoriasis after treatment.

[0078] a. Nail Psoriasis Severity Index (NAPSI) and Modified NAPSI (mNAPSI)

[0079] The Nail Psoriasis Severity Index (NAPSI) is a quantifiable, reproducible, objective, and simple tool for evaluating nail psoriasis. This scale is used to assess the severity of nail bed psoriasis and nail matrix psoriasis based on the area of ​​involvement at the nail unit. In one embodiment, the present disclosure provides a method for improving the total Nail Psoriasis Severity Index (mNAPSI) in a subject with nail psoriasis, the method comprising the steps of: administering an initial dose of humanized IL-23p19 IgG1 / K antibody to the subject at baseline (week 0); administering a second dose of humanized IL-23p19 IgG1 / K antibody to the subject about 4 weeks after the initial dose; and administering additional doses of humanized IL-23p19 IgG1 / K antibody to the subject about 16 weeks after the initial dose and thereafter every 12 weeks, wherein the final dose is administered to the subject about 52 weeks after the initial dose.

[0080] A modified version (mNAPSI) was developed to improve the dimensional validity and feasibility of the NAPSI. The mNAPSI measures onycholysis, punctate depressions, nail plate crumbling, succulence, microscopic hemorrhage, hyperkeratosis, and lunula red spots, and scores them as shown in Table 1. The cumulative score of the mNAPSI ranges from 0 to 130 for all nails of a given type.

[0081] [Table 1]

[0082] mNAPSI Measurement and Scoring

[0083]

[0084] In one embodiment, the present disclosure provides a method for improving the total-modified nail psoriasis severity index (mNAPSI) in a subject with nail psoriasis, the method comprising: (a) administering an initial dose of a humanized IL-23p19 IgG1 / K antibody to the subject at baseline (week 0); (b) administering a second dose of the humanized IL-23p19 IgG1 / K antibody to the subject about 4 weeks after the initial dose; and administering additional doses of the humanized IL-23p19 IgG1 / K antibody to the subject about 16 weeks after the initial dose and thereafter every 12 weeks, wherein the final dose is administered to the subject about 52 weeks after the initial dose.

[0085] NAPSI and mNAPSI are used to evaluate nail pitting, onycholysis and oil-drop dyspigmentation, nail crumbling, onycholesterolemia, blister hemorrhage, hyperkeratosis, and red spots on the lunula.

[0086] As used herein, the term "NAPSI" refers to the total matrix score of all affected nails. More specifically, each nail has a matrix score (0–4) and a nail bed score (0–4), the total nail score is the sum of these two individual scores (0–8), and the sum of the total scores of all affected nails is the total NAPSI score for the patient at that time. As shown in Table 2, the score is 0 if an item is not present, 1 if it is in the first quadrant of the nail, 2 if it is in the second quadrant, 3 if it is in the third quadrant, and 4 if it is in the fourth quadrant. The score range for a single nail is 0–8, and the sum of the scores for all nails is 0–80. An example of the nail quadrants is shown in Figure 2.

[0087] [Table 2]

[0088] Nail Psoriasis Severity Index

[0089]

[0090] Compare the mNAPSI and NAPSI assessment scores, and the total score indicates improvement, worsening, or no change in nail psoriasis. mNAPSI and NAPSI can be evaluated at any interval of about 2 weeks to about 52 weeks. For example, nail psoriasis can be evaluated at approximately week 0, week 2, week 4, week 6, week 8, week 10, week 12, week 14, week 16, week 18, week 20, week 22, week 24, week 26, week 28, week 30, week 32, week 34, week 36, week 38, week 40, week 42, week 44, week 46, week 48, week 50, and week 52. In one embodiment of the present disclosure, mNAPSI and NAPSI are evaluated at week 0, week 4, week 16, week 28, week 40, and week 52. The scores at each time point are compared for improvement, worsening, or no change in nail psoriasis.

[0091] As used herein, the term "mNAPSI 75" refers to a 75% improvement in a subject's total-mNAPSI score when compared at two time points. The score indicates therapeutic efficacy. In one embodiment of the present disclosure, the total-mNAPSI score at week 0 is compared with the same score at week 28, and the number of subjects who achieved mNAPSI 75 is reported. The total-mNAPSI score may be evaluated at any two time points from the time disclosed herein. The total-NAPSI score may also be evaluated in a similar manner.

[0092] As used herein, the term "mNAPSI 90" refers to a 90% improvement in a subject's total-mNAPSI score when compared at two time points. The score indicates therapeutic efficacy. In one embodiment of the present disclosure, the total-mNAPSI score at week 0 is compared with the same score at week 28, and the number of subjects who achieved a total-mNAPSI of 90 is reported. The total-mNAPSI score may be evaluated at any two time points from the time disclosed herein. The total-mNAPSI score may also be similarly evaluated and tracked over time.

[0093] As used herein, the term "mNAPSI 100" refers to a 100% improvement in a subject's mNAPSI score when compared at two time points. In some embodiments of the methods, compositions, and uses disclosed herein, the total-mNAPSI score at week 0 is compared to the same score at week 28, and the number of subjects who achieved a total-mNAPSI of 100 is reported. The total-mNAPSI score may be evaluated at any two time points from the time disclosed herein. The total-NAPSI score may also be similarly evaluated and tracked over time.

[0094] Total mNAPSI can also be evaluated to assess nail psoriasis and to compare the percentage of patients with a total mNAPSI score of 0 to 100. For example, scores from mNAPSI 0 to mNAPSI 100 can be assigned to nail psoriasis. However, the most commonly evaluated total mNAPSI scores are mNAPSI 75, mNAPSI 90, and mNAPSI 100.

[0095] As used herein, the term "moderate to severe onychomycosis" refers to an initial total mNAPSI score of >20. Onychomycosis may also be present when the initial total mNAPSI score is <20, but it is considered a less severe psoriatic condition. Subjects with a total mNAPSI can still benefit from the methods disclosed herein and are not ineligible to receive humanized IL-23p19 IgG1 / K antibodies.

[0096] As used herein, the term "total nail mNAPSI" refers to the total mNAPSI score evaluated solely for the nails. This enables comparison of nail types. It also allows for nail-specific comparisons regarding the improvement of nail psoriasis.

[0097] As used herein, the term “total nail mNAPSI” refers to a total mNAPSI score evaluated only for the nails. This enables nail-specific comparisons of improvement in nail psoriasis. Thus, the total mNAPSI score may be fingernail or nail-specific. In some embodiments of the methods, compositions, and uses of the present disclosure, total mNAPSI 75, total mNAPSI 90, and total mNAPSI 100 may be nail-specific. In alternative embodiments, total mNAPSI 75, total mNAPSI 90, or total mNAPSI 100 scores for nails and fingernails may be grouped to evaluate overall improvement in nail psoriasis.

[0098] As used herein, the term "nail" refers to toenails, fingernails, or both. As such, nail psoriasis may be fingernail psoriasis, toenail psoriasis, or both.

[0099] b. Visual Medical Scale for Assessing Severity of Nail Psoriasis (ViSENPsO)

[0100] As used herein, the term "Visual Medical Scale for the Assessment of Onysoriasis Severity (ViSENPsO)" refers to the Visual-Based Clinician Reported Outcomes (ClinRO) scale for the assessment of onysoriasis severity. ViSENPsO is a static scale developed by Sun Pharmaceuticals and is used as an efficacy endpoint to facilitate well-defined and reliable assessments of onysoriasis treatment outcomes in clinical trials involving biological agents.

[0101] In one embodiment, the present disclosure provides a method for improving ViSENPsO scores in subjects with nail psoriasis, the method comprising: administering an initial dose of humanized IL-23p19 IgG1 / K antibody to the subject at baseline (week 0); administering a second dose of humanized IL-23p19 IgG1 / K antibody to the subject about 4 weeks after the initial dose; and administering additional doses of humanized IL-23p19 IgG1 / K antibody to the subject about 16 weeks after the initial dose and thereafter every 12 weeks, wherein the final dose is administered to the subject about 52 weeks after the initial dose.

[0102] In another embodiment, the present disclosure provides a method for improving the total modified nail psoriasis severity index (mNAPSI) and / or ViSENPsO score and / or total nail psoriasis severity index (NAPSI) in a subject with nail psoriasis, the method comprising the steps of administering an initial dose of humanized IL-23p19 IgG1 / K antibody to the subject at baseline (week 0), administering a second dose of humanized IL-23p19 IgG1 / K antibody to the subject about 4 weeks after the initial dose, and administering additional doses of humanized IL-23p19 IgG1 / K antibody to the subject about 16 weeks after the initial dose and thereafter every 12 weeks, wherein the final dose is administered to the subject about 52 weeks after the initial dose.

[0103] An initial ViSENPsO score of >3 is an indicator of moderate to severe onychomycosis. A ViSENPsO score of <3 may indicate onychomycosis but is considered a less severe psoriatic condition. Subjects with an initial ViSENPsO can still benefit from the methods, compositions, and uses disclosed herein and are not ineligible to receive humanized IL-23p19 IgG1 / K antibodies.

[0104] mNAPSI and / or ViSENPsO scores can be used as indices for fingernail, toenail, or both severity. Toenail mNAPSI and / or ViSENPsO scores are not compared between toenails and fingernails, as they are for comparing the same type of nails. However, toenail and fingernail mNAPSI and / or ViSENPsO scores can be combined to assess total improvement in nail psoriasis.

[0105] As used herein, the terms “improvement of nail psoriasis” or “improved nail psoriasis” refer to a ViSENPsO score that decreases by at least 2 points when compared at two time points. In some embodiments of the methods, compositions, and uses of the present disclosure, ViSENPsO scores at week 0 and week 28 are compared to determine whether a subject shows improvement in nail psoriasis after receiving a humanized IL-23p19 IgG1 / K antibody.

[0106] c. Nail Pain Rating Scale (NRS)

[0107] As used at this institution, the term "Nail Pain Numerical Rating Scale (NRS)" refers to the assessment tool used by subjects to report the intensity of nail pain. A 30% improvement in the nail pain NRS score from baseline at Week 28 is considered an effective outcome. Pain measurement uses a 30% threshold using the "worst pain" item. Efficacy is assessed using a decrease of at least 3 points in the absolute nail pain NRS score on a scale of 0 to 10, where 0 is "no nail pain" and 10 is "imaginably severe nail pain." The NRS is subjectively rated at each visit as the most severe pain experienced during the previous 24 hours for each of the 7 consecutive days leading up to the time of assessment, and the average is calculated. The complete score at a given time is based on the average of at least 4 of the 7 daily recall observations.

[0108] In one embodiment, the present disclosure provides a method for improving the nail pain numerical rating scale (NRS) score in a subject with nail psoriasis, the method comprising the steps of: administering an initial dose of a humanized IL-23p19 IgG1 / K antibody to the subject at baseline (week 0); administering a second dose of the humanized IL-23p19 IgG1 / K antibody to the subject about 4 weeks after the initial dose; and administering additional doses of the humanized IL-23p19 IgG1 / K antibody to the subject about 16 weeks after the initial dose and thereafter every 12 weeks, wherein the final dose is administered to the subject about 52 weeks after the initial dose.

[0109] In some embodiments of the methods, compositions, and uses of the present disclosure, NRS scores may be used as an index of fingernail, toenail, or both severity. The same type of nail is compared, and thus NRS scores are not compared between toenails and fingernails. However, a combination of toenail and nail NRS scores may be used to evaluate total improvement in nail psoriasis. In some embodiments, improvement in nail psoriasis is achieved when the NRS score decreases by more than 30% between two time points. In one embodiment, improvement in nail psoriasis is achieved when the Week 28 NRS decreases by more than 30% compared to the Week 0 NRS.

[0110] As used herein, the terms “improvement of nail psoriasis” or “improved nail psoriasis” refer to a ViSENPsO score that decreases by at least 2 points when compared at two time points. In one embodiment, ViSENPsO scores at week 0 and week 28 are compared to determine whether the subject shows improvement in nail psoriasis after receiving the humanized IL-23p19 IgG1 / K antibody.

[0111] The nail psoriasis index disclosed herein may be determined as any number in the subject. In one embodiment of the present disclosure, there is a method for improving the total modified nail psoriasis severity index (mNAPSI) and / or the Visual Medical Scale for Evaluating Nail Psoriasis Severity (ViSENPsO) score and / or the total nail psoriasis severity index (NAPSI) in a subject with nail psoriasis, the method comprising the steps of administering an initial dose of humanized IL-23p19 IgG1 / K antibody to the subject at baseline (week 0), administering a second dose of humanized IL-23p19 IgG1 / K antibody to the subject about 4 weeks after the initial dose, and administering additional doses of humanized IL-23p19 IgG1 / K antibody to the subject about 16 weeks after the initial dose and thereafter every 12 weeks, wherein the final dose is administered to the subject about 52 weeks after the initial dose.

[0112] The humanized IL-23p19 IgG1 / K antibody may be administered at multiple time points. In one embodiment, the humanized IL-23p19 IgG1 / K antibody is administered early ( in other words , week 0) It is administered at multiple time points after administration.

[0113] As used herein, the terms “baseline” or “week 0” refer to the initial administration of the humanized IL-23p19 IgG1 / K antibody. In certain embodiments, as used herein, the term “baseline” may refer to the last observed value of the parameter of interest prior to the first administration of clinical trial treatment (this includes unplanned visits). Thereafter, the humanized IL-23p19 IgG1 / K antibody may be administered at approximately 4 weeks to approximately 15 weeks. The antibody may be administered at approximately 4 weeks, approximately 8 weeks, approximately 12 weeks, approximately 16 weeks, approximately 20 weeks, approximately 24 weeks, approximately 28 weeks, approximately 32 weeks, approximately 36 weeks, approximately 40 weeks, approximately 44 weeks, approximately 48 weeks, or approximately 52 weeks after baseline administration. Administration may be evenly spaced (e.g., every 4 weeks) or staggered at unequal intervals. In one embodiment, the humanized IL-23p19 IgG1 / K antibody is administered at approximately week 0, week 4, week 16, week 28, week 40, and week 52. Consistent with this, mNAPSI, NAPSI, ViSENPsO, and / or nail pain NRS are determined at the time of administration of the humanized IL-23p19 IgG1 / K antibody.

[0114] d. Total body surface area (BSA)

[0115] As used herein, the term "total body surface area" refers to a measure of the total severity of plaque psoriasis. It is defined as the percentage of the total BSA affected by psoriasis. The total BSA affected by psoriasis is measured at a specific point in time using the palm method, where the subject's hand (including the palmar side of the fingers) represents 1% of the BSA. The area affected by psoriasis is then calculated based on its size compared to the subject's palm.

[0116] e. Static physician's overall assessment (s-PGA)

[0117] As used herein, the term “physician’s overall assessment” (s-PGA) refers to a 5, 6, or 7-point scale ranging from “clear” to “severe” used to assess disease severity. In one embodiment of the present disclosure, a 6-point scale is used to assess disease severity at a given time. s-PGA is used to determine whether there is a disease deterioration that justifies discontinuing the subject’s clinical trial.

[0118] f. Clinicians' Overall Impression of Change (CGIC)

[0119] As used here, the term "clinician's overall impression of change" refers to a questionnaire that reflects the clinician's belief in the efficacy of the treatment.

[0120] g. Clinician regarding severity Overall impression of (CGIS)

[0121] As used herein, the term "clinician's overall impression of severity" refers to the overall index used by a clinician to assess the severity of a patient's specific condition. This scale is a single-state scale.

[0122] h. Dermatology Quality of Life Index (DLQI).

[0123] As used herein, the term "Dermatological Quality of Life Index" refers to an index used to evaluate the treatment response to a subject's quality of life. The purpose of this questionnaire is to measure how much nail psoriasis has affected a subject's life during the previous week (see Fig. 4).

[0124] Self-recall asks subjects to recall their experiences from the previous week by answering 10 questions. The DLQI is completed by subjects prior to safety or efficacy evaluation. The questionnaire is self-explanatory and is provided to subjects who are asked to complete it without detailed instructions.

[0125] i. Nail Evaluation in QoL of Psoriasis and Psoriatic Arthritis (NAPPA-QoL)

[0126] As used herein, the term "Nail Assessment of Quality of Life in Psoriasis and Psoriatic Arthritis" (NAPPA-QoL) refers to a questionnaire describing the quality of life in the presence of nail psoriasis of the hands and / or feet over the past week (Fig. 5).

[0127] j. Patient's overall impression of change (PGIC)

[0128] As used here, the term "Patient's Perspective on Change (PGIC)" refers to a questionnaire that reflects the patient's belief in the efficacy of the treatment.

[0129] k. Patient's overall impression of changes in pain (PGIC-P)

[0130] As used here, the term "Patient’s Overall Impression of Change (PGIC-P)" is an overall index used to grade changes in clinical condition, and changes in nail pain ( in other words It is used at this institution to evaluate PGIC-P).

[0131] l. Regarding severity Patient's overall impression (PGIS)

[0132] As used herein, the term "Patient’s Overall Impression of Severity" (PGIS) is an overall index that can be used to assess the severity of a specific condition (single-state scale).

[0133] m. Patient's overall impression of pain severity (PGIS-P)

[0134] As used at this institution, the term "Patient’s Overall Impression of Pain" (PGIS-P) is an overall index that can be used to grade the severity of any clinical condition. PGIS-P is used at this institution to assess the intensity of nail pain, and the response is also recorded at the follow-up visit after baseline, where PGIS is recorded.

[0135] All scales measuring psoriasis severity, pain, therapeutic efficacy, and quality of life are performed at one or more time points disclosed herein. In one embodiment, measurements are evaluated at week 0, week 4, week 16, week 28, week 40, and week 52.

[0136] For efficacy evaluation, ViSENPsO, NAPSI and mNAPSI, PGA-S, BSA, PASI, and nail pain NRS scores were assessed at each visit during the clinical trial. Subjects self-reported efficacy assessments, including patient-reported outcomes (PROs) and, in particular, the Dermatology Quality of Life Index [DLQI], Nail Assessment Quality of Life in Psoriasis and Psoriatic Arthritis [NAPPA-QoL], nail pain NRS, Patient's Overall Impression of Change [PGIC], Patient's Overall Impression of Change in Pain [PGIC-P], Patient's Overall Impression of Severity [PGIS], Patient's Overall Impression of Pain [PGIS-P], and the Columbia Suicide Severity Rating Scale [C-SSRS].

[0137] Implementation example

[0138] Embodiment 1: A method for treating nail psoriasis in a subject requiring treatment, wherein the method comprises the step of administering a therapeutically effective amount of the anti-IL-23p19 antibody hum13B8-b to the subject, and

[0139] A first dose of hum13B8-b is administered to the subject at week 0, a second dose of hum13B8-b is administered to the subject approximately 4 weeks after the first dose is administered, subsequent doses of hum13B8-b are administered to the subject approximately 16 weeks after the first dose is administered, and thereafter, a final dose of hum13B8-b is administered to the subject approximately 52 weeks after the first dose is administered,

[0140] hum13B8-b is a method comprising a light chain polypeptide having the amino acid sequence of SEQ ID NO. 1, and a heavy chain polypeptide having the amino acid sequence of SEQ ID NO. 2.

[0141] Embodiment 2: The method of Embodiment 1, wherein the nail psoriasis is fingernail psoriasis and / or toenail psoriasis.

[0142] Embodiment 3: The method of Embodiment 1, wherein the subject has plaque psoriasis.

[0143] Embodiment 4: In Embodiment 1, the first dose, second dose, subsequent dose, and final dose are the same, method.

[0144] Embodiment 5: The method of Embodiment 2, wherein the first dose, the second dose, the subsequent dose, and the final dose are about 100 mg.

[0145] Embodiment 6: The method of Embodiment 1, wherein the first dose, the second dose, the subsequent dose, and the final dose are about 5 mg to about 250 mg.

[0146] Embodiment 7: The method of Embodiment 1, wherein the first dose, the second dose, and the subsequent dose are about 5 mg, about 25 mg, about 100 mg, or about 200 mg.

[0147] Embodiment 8: A method of subcutaneously administering the anti-IL-23p19 antibody hum13B8-b to a subject in Embodiment 1.

[0148] Embodiment 9: A method of administering the anti-IL-23p19 antibody hum13B8-b to a subject by subcutaneous injection in Embodiment 8.

[0149] Embodiment 10: A method of administering the anti-IL-23p19 antibody hum13B8-b to the abdominal area of ​​the subject in Embodiment 8.

[0150] Embodiment 11: In Embodiment 1, the administration of the anti-IL-23p19 antibody hum13B8-b is as follows:

[0151] (a) Improvement in the total modified nail psoriasis severity index (mNAPSI) in the above subjects;

[0152] (b) improvement in the score of the scale for assessing nail psoriasis severity (ViSENPsO) in the above subjects; and / or

[0153] (c) A method that results in one or more improvements in the Total Nail Psoriasis Severity Index (NAPSI) in the subjects.

[0154] Embodiment 12: In Embodiment 11, the subject has a total mNAPSI at week 0 >20 and / or a Visual Medical Scale (ViSENPsO) score for evaluating nail psoriasis severity at week 0 >3.

[0155] Embodiment 13: The method of Embodiment 11, wherein the subject has a 28-week mNAPSI improved by >75% (mNAPSI 75) compared to the 0-week mNAPSI of the subject.

[0156] Embodiment 14: The method of Embodiment 11, wherein the subject has a 28-week mNAPSI improved by >90% (mNAPSI 90) compared to the subject's 0-week mNAPSI.

[0157] Embodiment 15: The method of Embodiment 11, wherein the subject has a 28-week mNAPSI improved by 100% (mNAPSI 100) compared to the 0-week mNAPSI of the subject.

[0158] Embodiment 16: In Embodiment 11, the total-mNAPSI is a total-nail mNAPSI.

[0159] Embodiment 17: The method of Embodiment 16, wherein the subject has a total-nail mNAPSI at week 28 that is improved by 90% (mNAPSI 90) compared to the subject's total-nail mNAPSI at week 0.

[0160] Embodiment 18: The method of Embodiment 16, wherein the subject has a total-nail mNAPSI at week 28 that is improved by 100% (mNAPSI 100) compared to the subject's total-nail mNAPSI at week 0.

[0161] Example 19: In Example 18, the method wherein NAPSI is a total-nail NAPSI.

[0162] Embodiment 20: The method of Embodiment 19, wherein the subject has a total fingernail NAPSI at week 28 that is improved by 75% (NAPSI 75) compared to the total fingernail NAPSI at week 0 of the subject.

[0163] Embodiment 21: The method of Embodiment 19, wherein the subject has a total fingernail NAPSI at week 28 that is improved by 90% (NAPSI 90) compared to the total fingernail NAPSI at week 0 of the subject.

[0164] Embodiment 22: The method of Embodiment 19, wherein the subject has a total fingernail NAPSI at week 28 that is improved by 100% (NAPSI 100) compared to the total fingernail NAPSI at week 0 of the subject.

[0165] Embodiment 23: The method of Embodiment 11, wherein the subject has a Week 28 ViSENPsO score that is reduced by at least 2 points compared to the Week 0 ViSENPsO score of the subject.

[0166] Embodiment 24: The method of Embodiment 1, wherein the administration of the anti-IL-23p19 antibody hum13B8-b results in an improvement in the nail pain numerical rating scale (NRS) score in the subject.

[0167] Example 25: In Example 24, the subject has a Week 0 NRS score of >3.

[0168] Embodiment 26: The method of Embodiment 24, wherein the subject has a Week 28 NRS score reduced by >30% compared to the Week 0 NRS score of the subject.

[0169] Embodiment 27: In Embodiment 1, the administration of the anti-IL-23p19 antibody hum13B8-b is as follows:

[0170] (a) Improvement in the modified nail psoriasis severity index (mNAPSI) in the above subjects;

[0171] (b) Improvement in the Nail Psoriasis Severity Index (NAPSI) in the above subjects;

[0172] (c) Improvement of the Visual Medical Scale (ViSENPsO) for assessing the severity of nail psoriasis in the above subjects; and / or

[0173] (d) A method that results in one or more improvements in the nail pain numerical rating scale (NRS) score in the subject.

[0174] Embodiment 28: The method of Embodiment 27, wherein the subject has improved week 28 mNAPSI, NAPSI, ViSeNPsO and / or NRS compared to the week 0 mNAPSI, NAPSI, ViSeNPsO and / or NRS of the subject.

[0175] Embodiment 29: In Embodiment 1, the administration of the anti-IL-23p19 antibody hum13B8-b increases the quality of life (QoL) in the subject.

[0176] Embodiment 30: A method of administering one or more doses of the anti-IL-23p19 antibody hum13B8-b to a subject using a pre-filled syringe available for immediate use, in any one of the previous embodiments.

[0177] Embodiment 31: The method of Embodiment 30, wherein the pre-filled syringe contains about 100 mg of hum13B8-b, an excipient, and a buffer.

[0178] Embodiment 32: The method of Embodiment 31, wherein the pre-filled syringe further comprises L-histidine, L-histidine hydrochloride monohydrate, sucrose, and polysorbate 80.

[0179] Implementation Example 33: Next:

[0180] (a) Total-Deformed Nail Psoriasis Severity Index (mNAPSI);

[0181] (b) Scale for assessing the severity of nail psoriasis (ViSENPsO) score; and / or

[0182] (c) One or more of the Total Nail Psoriasis Severity Index (NAPSI)

[0183] A method for improving nail psoriasis in a subject, wherein the method comprises the step of administering a therapeutically effective amount of the anti-IL-23p19 antibody hum13B8-b to the subject,

[0184] A first dose of hum13B8-b is administered to the subject at week 0, a second dose of hum13B8-b is administered to the subject approximately 4 weeks after the first dose is administered, subsequent doses of hum13B8-b are administered to the subject approximately 16 weeks after the first dose is administered, and thereafter, a final dose of hum13B8-b is administered to the subject approximately 52 weeks after the first dose is administered,

[0185] hum13B8-b is used for a light chain polypeptide comprising the amino acid sequence of SEQ ID NO. 1, and a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO. 2.

[0186] Embodiment 34: In Embodiment 33, the subject has a total mNAPSI at week 0 >20 and / or a Visual Medical Scale (ViSENPsO) score for evaluating nail psoriasis severity at week 0 >3.

[0187] Embodiment 35: The method of Embodiment 33, wherein the subject has a 28-week mNAPSI improved by >75% (mNAPSI 75) compared to the 0-week mNAPSI of the subject.

[0188] Embodiment 36: The method of Embodiment 33, wherein the subject has a 28-week mNAPSI improved by >90% (mNAPSI 90) compared to the 0-week mNAPSI of the subject.

[0189] Embodiment 37: The method of Embodiment 33, wherein the subject has a 28-week mNAPSI improved by 100% (mNAPSI 100) compared to the 0-week mNAPSI of the subject.

[0190] Embodiment 38: In Embodiment 33, the total -mNAPSI is the total nail mNAPSI.

[0191] Embodiment 39: The method of Embodiment 38, wherein the subject has a total-nail mNAPSI at week 28 that is improved by 90% (mNAPSI 90) compared to the subject's total-nail mNAPSI at week 0.

[0192] Embodiment 40: The method of Embodiment 38, wherein the subject has a total-nail mNAPSI at week 28 that is improved by 100% (mNAPSI 100) compared to the subject's total-nail mNAPSI at week 0.

[0193] Embodiment 41: In Embodiment 33, the NAPSI is a total-nail NAPSI, method.

[0194] Embodiment 42: The method of Embodiment 41, wherein the subject has a total fingernail NAPSI at week 28 that is improved by 75% (NAPSI 75) compared to the total fingernail NAPSI at week 0 of the subject.

[0195] Embodiment 43: The method of Embodiment 41, wherein the subject has a total fingernail NAPSI at week 28 that is improved by 90% (NAPSI 90) compared to the total fingernail NAPSI at week 0 of the subject.

[0196] Embodiment 44: The method of Embodiment 41, wherein the subject has a total fingernail NAPSI at week 28 that is improved by 100% (NAPSI 100) compared to the total fingernail NAPSI at week 0 of the subject.

[0197] Embodiment 45: The method of Embodiment 33, wherein the subject has a Week 28 ViSENPsO score that is reduced by at least 2 points compared to the Week 0 ViSENPsO score of the subject.

[0198] Embodiment 46: A method for improving the nail pain numerical rating scale (NRS) score in a subject with nail psoriasis, wherein the method comprises the step of administering a therapeutically effective amount of the anti-IL-23p19 antibody hum13B8-b to the subject,

[0199] A first dose of hum13B8-b is administered to the subject at week 0, a second dose of hum13B8-b is administered to the subject approximately 4 weeks after the first dose is administered, subsequent doses of hum13B8-b are administered to the subject approximately 16 weeks after the first dose is administered, and thereafter every 12 weeks, a final dose of hum13B8-b is administered to the subject approximately 52 weeks after the first dose is administered.

[0200] hum13B8-b is used for a light chain polypeptide comprising the amino acid sequence of SEQ ID NO. 1, and a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO. 2.

[0201] Example 47: In Example 46, the subject has a Week 0 NRS score of >3.

[0202] Embodiment 48: The method of Embodiment 46, wherein the subject has a Week 28 NRS score reduced by >30% compared to the Week 0 NRS score of the subject.

[0203] Implementation Example 49: Next:

[0204] (a) Modified Nail Psoriasis Severity Index (mNAPSI);

[0205] (b) Nail Psoriasis Severity Index (NAPSI);

[0206] (c) Visual Medical Scale for Assessing Severity of Nail Psoriasis (ViSENPsO); and / or

[0207] (d) One or more of the Nail Pain Rating Scale (NRS) scores

[0208] A method for improving nail psoriasis in a subject, wherein the method comprises the step of administering a therapeutically effective amount of the anti-IL-23p19 antibody hum13B8-b to the subject,

[0209] A first dose of hum13B8-b is administered to the subject at week 0, a second dose of hum13B8-b is administered to the subject approximately 4 weeks after the first dose is administered, subsequent doses of hum13B8-b are administered to the subject approximately 16 weeks after the first dose is administered, and thereafter, a final dose of hum13B8-b is administered to the subject approximately 52 weeks after the first dose is administered,

[0210] hum13B8-b is used for a light chain polypeptide comprising the amino acid sequence of SEQ ID NO. 1, and a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO. 2.

[0211] Embodiment 50: The method of Embodiment 49, wherein the subject has improved week 28 mNAPSI, NAPSI, ViSeNPsO and / or NRS compared to the week 0 mNAPSI, NAPSI, ViSeNPsO and / or NRS of the subject.

[0212] Embodiment 51: A method for increasing the quality of life (QoL) in a subject with nail psoriasis, wherein the method comprises the step of administering a therapeutically effective amount of the anti-IL-23p19 antibody hum13B8-b to the subject,

[0213] A first dose of hum13B8-b is administered to the subject at week 0, a second dose of hum13B8-b is administered to the subject approximately 4 weeks after the first dose is administered, subsequent doses of hum13B8-b are administered to the subject approximately 16 weeks after the first dose is administered, and thereafter, a final dose of hum13B8-b is administered to the subject approximately 52 weeks after the first dose is administered,

[0214] hum13B8-b is used for a light chain polypeptide comprising the amino acid sequence of SEQ ID NO. 1, and a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO. 2.

[0215] Embodiment 52: A method in any one of Embodiments 33 to 51, wherein the nail psoriasis is fingernail psoriasis and / or toenail psoriasis.

[0216] Embodiment 53: A method in any one of Embodiments 33 to 51, wherein the subject has plaque psoriasis.

[0217] Embodiment 54: In any one of Embodiments 33 to 51, the first dose, the second dose, the subsequent dose, and the final dose are the same.

[0218] Embodiment 55: The method of Embodiment 54, wherein the first dose, the second dose, the subsequent dose, and the final dose are about 100 mg.

[0219] Embodiment 56: A method in any one of Embodiments 33 to 51, wherein the first dose, second dose, subsequent dose, and final dose are about 5 mg to about 250 mg.

[0220] Embodiment 57: A method in any one of Embodiments 33 to 51, wherein the first dose, second dose, subsequent dose, and final dose are about 5 mg, about 25 mg, about 100 mg, or about 200 mg.

[0221] Embodiment 58: A method of subcutaneously administering the anti-IL-23p19 antibody hum13B8-b to a subject in any one of Embodiments 33 to 57.

[0222] Embodiment 59: A method of administering the anti-IL-23p19 antibody hum13B8-b to a subject by subcutaneous injection in Embodiment 58.

[0223] Embodiment 60: A method of administering the anti-IL-23p19 antibody hum13B8-b to the abdominal area of ​​the subject in Embodiment 58.

[0224] Embodiment 61: A method in any one of Embodiments 33 to 60, wherein one or more doses of the anti-IL-23p19 antibody hum13B8-b are administered to a subject using a pre-filled syringe available for immediate use.

[0225] Embodiment 62: The method of Embodiment 61, wherein the pre-filled syringe contains about 100 mg of hum13B8-b, an excipient, and a buffer.

[0226] Embodiment 63: The method of Embodiment 62, wherein the pre-filled syringe further comprises L-histidine, L-histidine hydrochloride monohydrate, sucrose, and polysorbate 80.

[0227] Embodiment 64: A pharmaceutical composition of the anti-IL-23p19 antibody hum13B8-b for treating nail psoriasis in subjects,

[0228] A first dose of the above pharmaceutical composition is administered to the subject at week 0, a second dose of the above pharmaceutical composition is administered to the subject approximately at week 4 after the first dose is administered to the subject, subsequent doses of the above pharmaceutical composition are administered to the subject approximately at week 16 after the first dose is administered to the subject and thereafter at approximately every 12 weeks, and a final dose of the above pharmaceutical composition is administered to the subject approximately at week 52 after the first dose is administered to the subject.

[0229] hum13B8-b is a pharmaceutical composition comprising a light chain polypeptide having the amino acid sequence of SEQ ID NO. 1, and a heavy chain polypeptide having the amino acid sequence of SEQ ID NO. 2.

[0230] Embodiment 65: A pharmaceutical composition in which, in Embodiment 64, the nail psoriasis is fingernail psoriasis and / or toenail psoriasis.

[0231] Embodiment 66: A pharmaceutical composition in which, in Embodiment 64, the subject has plaque psoriasis.

[0232] Embodiment 67: A pharmaceutical composition in which the first dose, second dose, subsequent dose, and final dose are the same as in Embodiment 64.

[0233] Embodiment 68: A pharmaceutical composition in Embodiment 65, wherein the first dose, second dose, subsequent dose, and final dose are about 100 mg of hum13B8-b.

[0234] Embodiment 69: A pharmaceutical composition in Embodiment 64, wherein the first dose, second dose, subsequent dose, and final dose are hum13B8-b of about 5 mg to about 250 mg.

[0235] Embodiment 70: A pharmaceutical composition in Embodiment 64, wherein the first dose, the second dose, and the subsequent dose are about 5 mg, about 25 mg, about 100 mg, or about 200 mg of hum13B8-b.

[0236] Embodiment 71: In Embodiment 64, the pharmaceutical composition is administered subcutaneously to the subject.

[0237] Embodiment 72: The pharmaceutical composition of Embodiment 71, wherein the pharmaceutical composition is administered to the subject by subcutaneous injection.

[0238] Embodiment 73: The pharmaceutical composition of Embodiment 71, wherein the pharmaceutical composition is administered to the abdominal area of ​​the subject.

[0239] Embodiment 74: In Embodiment 64, the administration of the pharmaceutical composition is as follows:

[0240] (a) Improvement in the total modified nail psoriasis severity index (mNAPSI) in the above subjects;

[0241] (b) improvement in the score of the scale for assessing nail psoriasis severity (ViSENPsO) in the above subjects; and / or

[0242] (c) A pharmaceutical composition that results in one or more improvements in the Total Nail Psoriasis Severity Index (NAPSI) in the subjects mentioned above.

[0243] Embodiment 75: A pharmaceutical composition in which, in Embodiment 74, the subject has a total mNAPSI at week 0 >20 and / or a Visual Medical Scale (ViSENPsO) score for evaluating nail psoriasis severity at week 0 >3.

[0244] Embodiment 76: A pharmaceutical composition in which, in Embodiment 74, the subject has a 28-week mNAPSI improved by >75% (mNAPSI 75) compared to the 0-week mNAPSI of the subject.

[0245] Embodiment 77: A pharmaceutical composition in which, in Embodiment 74, the subject has a 28-week mNAPSI improved by >90% (mNAPSI 90) compared to the 0-week mNAPSI of the subject.

[0246] Embodiment 78: A pharmaceutical composition in which, in Embodiment 74, the subject has a 28-week mNAPSI improved by 100% (mNAPSI 100) compared to the 0-week mNAPSI of the subject.

[0247] Embodiment 79: A pharmaceutical composition in which, in Embodiment 74, the total-mNAPSI is total-nail mNAPSI.

[0248] Embodiment 80: A pharmaceutical composition in which, in Embodiment 79, the subject has a total-nail mNAPSI at week 28 that is improved by 90% (mNAPSI 90) compared to the total-nail mNAPSI at week 0 of the subject.

[0249] Embodiment 81: A pharmaceutical composition in which, in Embodiment 79, the subject has a total-nail mNAPSI at week 28 that is improved by 100% (mNAPSI 100) compared to the total-nail mNAPSI at week 0 of the subject.

[0250] Embodiment 82: A pharmaceutical composition in which, in Embodiment 81, NAPSI is a total-nail NAPSI.

[0251] Embodiment 83: A pharmaceutical composition in which, in Embodiment 82, the subject has a total nail NAPSI at week 28 that is improved by 75% (NAPSI 75) compared to the total nail NAPSI at week 0 of the subject.

[0252] Embodiment 84: A pharmaceutical composition in which, in Embodiment 82, the subject has a total nail NAPSI at week 28 that is improved by 90% (NAPSI 90) compared to the total nail NAPSI at week 0 of the subject.

[0253] Embodiment 85: A pharmaceutical composition in which, in Embodiment 82, the subject has a total nail NAPSI at week 28 that is improved by 100% (NAPSI 100) compared to the total nail NAPSI at week 0 of the subject.

[0254] Embodiment 86: A pharmaceutical composition in which, in Embodiment 74, the subject has a Week 28 ViSENPsO score that is reduced by at least 2 points compared to the Week 0 ViSENPsO score of the subject.

[0255] Embodiment 87: A pharmaceutical composition in Embodiment 64, wherein administration of the pharmaceutical composition results in an improvement in the nail pain numerical rating scale (NRS) score in the subject.

[0256] Embodiment 88: The pharmaceutical composition of Embodiment 87, wherein the subject has a Week 0 NRS score of >3.

[0257] Embodiment 89: A pharmaceutical composition in which, in Embodiment 87, the subject has a Week 28 NRS score reduced by >30% compared to the Week 0 NRS score of the subject.

[0258] Embodiment 90: In Embodiment 64, the administration of the pharmaceutical composition is as follows:

[0259] (a) Improvement in the modified nail psoriasis severity index (mNAPSI) in the above subjects;

[0260] (b) Improvement in the Nail Psoriasis Severity Index (NAPSI) in the above subjects;

[0261] (c) Improvement of the Visual Medical Scale (ViSENPsO) for assessing the severity of nail psoriasis in the above subjects; and / or

[0262] (d) A pharmaceutical composition that results in one or more improvements in the nail pain numerical rating scale (NRS) score in the above subjects.

[0263] Embodiment 91: A pharmaceutical composition in Embodiment 90, wherein the subject has improved week 28 mNAPSI, NAPSI, ViSeNPsO and / or NRS compared to week 0 mNAPSI, NAPSI, ViSeNPsO and / or NRS of the subject.

[0264] Embodiment 92: The pharmaceutical composition of Embodiment 64, wherein administration of the pharmaceutical composition increases the quality of life (QoL) in the subject.

[0265] Embodiment 93: A pharmaceutical composition in any one of the aforementioned embodiments, wherein one or more doses of the pharmaceutical composition are administered to a subject using a pre-filled syringe that is immediately available for use.

[0266] Embodiment 94: The pharmaceutical composition of Embodiment 93, wherein the pre-filled syringe contains about 100 mg of hum13B8-b, an excipient, and a buffer.

[0267] Embodiment 95: The pharmaceutical composition of Embodiment 94, wherein the pre-filled syringe further comprises L-histidine, L-histidine hydrochloride monohydrate, sucrose, and polysorbate 80.

[0268] Embodiment 96: As a pharmaceutical composition of the anti-IL-23p19 antibody hum13B8-b, the following:

[0269] (a) Total-Deformed Nail Psoriasis Severity Index (mNAPSI);

[0270] (b) Scale for assessing the severity of nail psoriasis (ViSENPsO) score; and / or

[0271] (c) One or more of the Total Nail Psoriasis Severity Index (NAPSI)

[0272] As for improvement in subjects with nail psoriasis,

[0273] A first dose of the above pharmaceutical composition is administered to the subject at week 0, a second dose of the above pharmaceutical composition is administered to the subject approximately at week 4 after the first dose is administered to the subject, subsequent doses of the above pharmaceutical composition are administered to the subject approximately at week 16 after the first dose is administered to the subject and thereafter at approximately every 12 weeks, and a final dose of the above pharmaceutical composition is administered to the subject approximately at week 52 after the first dose is administered to the subject.

[0274] hum13B8-b is a pharmaceutical composition comprising a light chain polypeptide having the amino acid sequence of SEQ ID NO. 1, and a heavy chain polypeptide having the amino acid sequence of SEQ ID NO. 2.

[0275] Embodiment 97: The pharmaceutical composition of Embodiment 96, wherein the subject has a total mNAPSI at week 0 of >20 and / or a Visual Medical Scale (ViSENPsO) score for evaluating nail psoriasis severity at week 0 of >3.

[0276] Embodiment 98: A pharmaceutical composition in which, in Embodiment 96, the subject has a 28-week mNAPSI improved by >75% (mNAPSI 75) compared to the 0-week mNAPSI of the subject.

[0277] Embodiment 99: A pharmaceutical composition in which, in Embodiment 96, the subject has a 28-week mNAPSI improved by >90% (mNAPSI 90) compared to the 0-week mNAPSI of the subject.

[0278] Embodiment 100: A pharmaceutical composition in which, in Embodiment 96, the subject has a 28-week mNAPSI improved by 100% (mNAPSI 100) compared to the subject's 0-week mNAPSI.

[0279] Embodiment 101: A pharmaceutical composition in which, in Embodiment 96, the total-mNAPSI is total-nail mNAPSI.

[0280] Embodiment 102: A pharmaceutical composition in which, in Embodiment 101, the subject has a total-nail mNAPSI at week 28 that is improved by 90% (mNAPSI 90) compared to the total-nail mNAPSI at week 0 of the subject.

[0281] Embodiment 103: A pharmaceutical composition in which, in Embodiment 101, the subject has a total-nail mNAPSI at week 28 that is improved by 100% (mNAPSI 100) compared to the total-nail mNAPSI at week 0 of the subject.

[0282] Embodiment 104: A pharmaceutical composition in which, in Embodiment 96, NAPSI is a total-nail NAPSI.

[0283] Embodiment 105: A pharmaceutical composition in which, in Embodiment 104, the subject has a total nail NAPSI at week 28 that is improved by 75% (NAPSI 75) compared to the total nail NAPSI at week 0 of the subject.

[0284] Embodiment 106: A pharmaceutical composition in which, in Embodiment 104, the subject has a total nail NAPSI at week 28 that is improved by 90% (NAPSI 90) compared to the total nail NAPSI at week 0 of the subject.

[0285] Embodiment 107: A pharmaceutical composition in which, in Embodiment 104, the subject has a total nail NAPSI at week 28 that is improved by 100% (NAPSI 100) compared to the total nail NAPSI at week 0 of the subject.

[0286] Embodiment 108: A pharmaceutical composition in which, in Embodiment 96, the subject has a Week 28 ViSENPsO score that is reduced by at least 2 points compared to the Week 0 ViSENPsO score of the subject.

[0287] Embodiment 109: A pharmaceutical composition of the anti-IL-23p19 antibody hum13B8-b for improving the nail pain numerical rating scale (NRS) score in subjects with nail psoriasis,

[0288] A first dose of the above pharmaceutical composition is administered to the subject at week 0, a second dose of the above pharmaceutical composition is administered to the subject approximately at week 4 after the first dose is administered to the subject, subsequent doses of the above pharmaceutical composition are administered to the subject approximately at week 16 after the first dose is administered to the subject and thereafter at approximately every 12 weeks, and a final dose of the above pharmaceutical composition is administered to the subject approximately at week 52 after the first dose is administered to the subject.

[0289] hum13B8-b is a pharmaceutical composition comprising a light chain polypeptide having the amino acid sequence of SEQ ID NO. 1, and a heavy chain polypeptide having the amino acid sequence of SEQ ID NO. 2.

[0290] Embodiment 110: The pharmaceutical composition of Embodiment 109, wherein the subject has a Week 0 NRS score of >3.

[0291] Embodiment 111: A pharmaceutical composition in Embodiment 109, wherein the subject has a Week 28 NRS score reduced by >30% compared to the Week 0 NRS score of the subject.

[0292] Embodiment 112: As a pharmaceutical composition of the anti-IL-23p19 antibody hum13B8-b, the following:

[0293] (a) Modified Nail Psoriasis Severity Index (mNAPSI);

[0294] (b) Nail Psoriasis Severity Index (NAPSI);

[0295] (c) Visual Medical Scale for Assessing Severity of Nail Psoriasis (ViSENPsO); and / or

[0296] (d) One or more of the Nail Pain Rating Scale (NRS) scores

[0297] As for improvement in subjects with nail psoriasis,

[0298] A first dose of the above pharmaceutical composition is administered to the subject at week 0, a second dose of the above pharmaceutical composition is administered to the subject approximately at week 4 after the first dose is administered to the subject, subsequent doses of the above pharmaceutical composition are administered to the subject approximately at week 16 after the first dose is administered to the subject and thereafter at approximately every 12 weeks, and a final dose of the above pharmaceutical composition is administered to the subject approximately at week 52 after the first dose is administered to the subject.

[0299] hum13B8-b is a pharmaceutical composition comprising a light chain polypeptide having the amino acid sequence of SEQ ID NO. 1, and a heavy chain polypeptide having the amino acid sequence of SEQ ID NO. 2.

[0300] Embodiment 113: A pharmaceutical composition in which, in Embodiment 112, the subject has improved week 28 mNAPSI, NAPSI, ViSeNPsO and / or NRS compared to week 0 mNAPSI, NAPSI, ViSeNPsO and / or NRS of the subject.

[0301] Embodiment 114: A pharmaceutical composition of the anti-IL-23p19 antibody hum13B8-b for increasing the quality of life (QoL) in subjects with nail psoriasis,

[0302] A first dose of the above pharmaceutical composition is administered to the subject at week 0, a second dose of the above pharmaceutical composition is administered to the subject approximately at week 4 after the first dose is administered to the subject, subsequent doses of the above pharmaceutical composition are administered to the subject approximately at week 16 after the first dose is administered to the subject and thereafter at approximately every 12 weeks, and a final dose of the above pharmaceutical composition is administered to the subject approximately at week 52 after the first dose is administered to the subject.

[0303] hum13B8-b is a pharmaceutical composition comprising a light chain polypeptide having the amino acid sequence of SEQ ID NO. 1, and a heavy chain polypeptide having the amino acid sequence of SEQ ID NO. 2.

[0304] Embodiment 115: A pharmaceutical composition in any one of Embodiments 96 to 114, wherein the nail psoriasis is fingernail psoriasis and / or toenail psoriasis.

[0305] Embodiment 116: A pharmaceutical composition in any one of Embodiments 96 to 114, wherein the subject has plaque psoriasis.

[0306] Embodiment 117: A pharmaceutical composition in any one of Embodiments 96 to 114, wherein the first dose, the second dose, the subsequent dose, and the final dose are the same.

[0307] Embodiment 118: A pharmaceutical composition in Embodiment 117, wherein the first dose, second dose, subsequent dose, and final dose are about 100 mg of hum13B8-b.

[0308] Embodiment 119: A pharmaceutical composition in any one of Embodiments 96 to 114, wherein the first dose, the second dose, the subsequent dose, and the final dose are about 5 mg to about 250 mg of hum13B8-b.

[0309] Embodiment 120: A pharmaceutical composition in any one of Embodiments 96 to 114, wherein the first dose, the second dose, the subsequent dose, and the final dose are about 5 mg, about 25 mg, about 100 mg, or about 200 mg of hum13B8-b.

[0310] Embodiment 121: Any one of Embodiments 96 to 120, wherein the pharmaceutical composition is administered subcutaneously to a subject.

[0311] Embodiment 122: The pharmaceutical composition of Embodiment 121, wherein the pharmaceutical composition is administered to the subject by subcutaneous injection.

[0312] Embodiment 123: The pharmaceutical composition of Embodiment 121, wherein the pharmaceutical composition is administered to the abdominal area of ​​the subject.

[0313] Embodiment 124: A pharmaceutical composition in any one of Embodiments 96 to 123, wherein one or more doses of the pharmaceutical composition are administered to a subject using a pre-filled syringe that is ready for immediate use.

[0314] Embodiment 125: The pharmaceutical composition of Embodiment 124, wherein the pre-filled syringe contains about 100 mg of hum13B8-b, an excipient, and a buffer.

[0315] Embodiment 126: The pharmaceutical composition of Embodiment 125, wherein the pre-filled syringe further comprises L-histidine, L-histidine hydrochloride monohydrate, sucrose, and polysorbate 80.

[0316] Embodiment 127: Use of the anti-IL-23p19 antibody hum13B8-b for the manufacture of a medicine to treat nail psoriasis in subjects,

[0317] A first dose of the above-mentioned medicine is administered to the subject at week 0, a second dose of the above-mentioned medicine is administered to the subject at approximately week 4 after the first dose is administered to the subject, subsequent doses of the above-mentioned medicine are administered to the subject at approximately week 16 after the first dose is administered to the subject and thereafter at approximately every 12 weeks, and a final dose of the above-mentioned medicine is administered to the subject at approximately week 52 after the first dose is administered to the subject,

[0318] hum13B8-b is used for a light chain polypeptide comprising the amino acid sequence of SEQ ID NO. 1, and a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO. 2.

[0319] Embodiment 128: In Embodiment 127, the nail psoriasis is fingernail psoriasis and / or toenail psoriasis.

[0320] Embodiment 129: In Embodiment 127, the subject has plaque psoriasis.

[0321] Embodiment 130: In Embodiment 127, the first dose, second dose, subsequent dose, and final dose are the same for use.

[0322] Embodiment 131: In Embodiment 128, the first dose, second dose, subsequent dose, and final dose are about 100 mg of hum13B8-b.

[0323] Embodiment 132: The use of Embodiment 127, wherein the first dose, second dose, subsequent dose and final dose are about 5 mg to about 250 mg of hum13B8-b.

[0324] Embodiment 133: In Embodiment 127, the first dose, the second dose, and the subsequent dose are hum13B8-b of about 5 mg, about 25 mg, about 100 mg, or about 200 mg.

[0325] Embodiment 134: In Embodiment 127, the above medicine is administered subcutaneously to the subject.

[0326] Embodiment 135: In Embodiment 134, the above-mentioned medicine is administered to the subject by subcutaneous injection.

[0327] Embodiment 136: In Embodiment 134, the above-mentioned medicine is used to be administered to the abdominal area of ​​the subject.

[0328] Embodiment 137: In Embodiment 127, the administration of the above-mentioned medicine is as follows:

[0329] (a) Improvement in the total modified nail psoriasis severity index (mNAPSI) in the above subjects;

[0330] (b) improvement in the score of the scale for assessing nail psoriasis severity (ViSENPsO) in the above subjects; and / or

[0331] (c) Use resulting in one or more improvements in the Total Nail Psoriasis Severity Index (NAPSI) in the subjects mentioned above.

[0332] Embodiment 138: In Embodiment 137, the subject has a total mNAPSI at week 0 >20 and / or a Visual Medical Scale for Evaluating Nail Psoriasis Severity (ViSENPsO) score at week 0 >3.

[0333] Embodiment 139: In Embodiment 137, the subject has a Week 28 mNAPSI improved by >75% (mNAPSI 75) compared to the Week 0 mNAPSI of the subject.

[0334] Embodiment 140: In Embodiment 137, the subject has a Week 28 mNAPSI improved by >90% (mNAPSI 90) compared to the Week 0 mNAPSI of the subject.

[0335] Embodiment 141: In Embodiment 137, the subject has a 28-week mNAPSI that is improved by 100% (mNAPSI 100) compared to the 0-week mNAPSI of the subject.

[0336] Embodiment 142: In Embodiment 137, the total-mNAPSI is a total-nail mNAPSI.

[0337] Embodiment 143: In Embodiment 142, the subject has a total-nail mNAPSI at week 28 that is improved by 90% (mNAPSI 90) compared to the total-nail mNAPSI at week 0 of the subject.

[0338] Embodiment 144: In Embodiment 142, the subject has a total-nail mNAPSI at week 28 that is improved by 100% (mNAPSI 100) compared to the subject's total-nail mNAPSI at week 0.

[0339] Embodiment 145: In Embodiment 144, the NAPSI is a total-nail NAPSI.

[0340] Embodiment 146: In Embodiment 145, the subject has a total fingernail NAPSI at week 28 that is improved by 75% (NAPSI 75) compared to the total fingernail NAPSI at week 0 of the subject.

[0341] Embodiment 147: In Embodiment 145, the subject has a total fingernail NAPSI at week 28 that is improved by 90% (NAPSI 90) compared to the total fingernail NAPSI at week 0 of the subject.

[0342] Embodiment 148: In Embodiment 145, the subject has a total fingernail NAPSI at week 28 that is improved by 100% (NAPSI 100) compared to the total fingernail NAPSI at week 0 of the subject.

[0343] Embodiment 149: In Embodiment 137, the subject has a Week 28 ViSENPsO score that is reduced by at least 2 points compared to the Week 0 ViSENPsO score of the subject.

[0344] Embodiment 150: In Embodiment 127, the administration of the medicine results in an improvement in the nail pain numerical rating scale (NRS) score in the subject.

[0345] Embodiment 151: In Embodiment 150, the subject has a Week 0 NRS score of >3.

[0346] Embodiment 152: In Embodiment 150, the subject has a Week 28 NRS score that is reduced by >30% compared to the Week 0 NRS score of the subject.

[0347] Embodiment 153: In Embodiment 127, the administration of the above-mentioned medicine is as follows:

[0348] (a) Improvement in the modified nail psoriasis severity index (mNAPSI) in the above subjects;

[0349] (b) Improvement in the Nail Psoriasis Severity Index (NAPSI) in the above subjects;

[0350] (c) Improvement of the Visual Medical Scale (ViSENPsO) for assessing the severity of nail psoriasis in the above subjects; and / or

[0351] (d) Use resulting in one or more improvements in the nail pain numerical rating scale (NRS) score in the above subjects.

[0352] Embodiment 154: In Embodiment 153, the subject has improved week 28 mNAPSI, NAPSI, ViSeNPsO and / or NRS compared to week 0 mNAPSI, NAPSI, ViSeNPsO and / or NRS of the subject.

[0353] Embodiment 155: In Embodiment 127, the administration of the medicine is for use in increasing the quality of life (QoL) of the subject.

[0354] Embodiment 156: In any one of the aforementioned embodiments, an use of administering one or more doses of the medicine to a subject using a pre-filled syringe that is immediately available for use.

[0355] Embodiment 157: In Embodiment 156, the pre-filled syringe contains about 100 mg of hum13B8-b, an excipient, and a buffer solution.

[0356] Embodiment 158: In Embodiment 157, the pre-filled syringe further comprises L-histidine, L-histidine hydrochloride monohydrate, sucrose, and polysorbate 80 for use.

[0357] Embodiment 159: As a use of the anti-IL-23p19 antibody hum13B8-b for the manufacture of a drug, the following:

[0358] (a) Total-Deformed Nail Psoriasis Severity Index (mNAPSI);

[0359] (b) Scale for assessing the severity of nail psoriasis (ViSENPsO) score; and / or

[0360] (c) One or more of the Total Nail Psoriasis Severity Index (NAPSI)

[0361] As for improvement in subjects with nail psoriasis,

[0362] A first dose of the above-mentioned medicine is administered to the subject at week 0, a second dose of the above-mentioned medicine is administered to the subject at approximately week 4 after the first dose is administered to the subject, subsequent doses of the above-mentioned medicine are administered to the subject at approximately week 16 after the first dose is administered to the subject and thereafter at approximately every 12 weeks, and a final dose of the above-mentioned medicine is administered to the subject at approximately week 52 after the first dose is administered to the subject,

[0363] hum13B8-b is used for a light chain polypeptide comprising the amino acid sequence of SEQ ID NO. 1, and a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO. 2.

[0364] Embodiment 160: In Embodiment 159, the subject has a total mNAPSI at week 0 of >20 and / or a Visual Medical Scale (ViSENPsO) score for evaluating nail psoriasis severity at week 0 of >3.

[0365] Embodiment 161: In Embodiment 159, the subject has a Week 28 mNAPSI improved by >75% (mNAPSI 75) compared to the Week 0 mNAPSI of the subject.

[0366] Embodiment 162: In Embodiment 159, the subject has a Week 28 mNAPSI improved by >90% (mNAPSI 90) compared to the Week 0 mNAPSI of the subject.

[0367] Embodiment 163: In Embodiment 159, the subject has a 28-week mNAPSI improved by 100% (mNAPSI 100) compared to the 0-week mNAPSI of the subject.

[0368] Embodiment 164: In Embodiment 159, the total-mNAPSI is a total-nail mNAPSI.

[0369] Embodiment 165: In Embodiment 164, the subject has a total-nail mNAPSI at week 28 that is improved by 90% (mNAPSI 90) compared to the total-nail mNAPSI at week 0 of the subject.

[0370] Embodiment 166: In Embodiment 164, the subject has a total-nail mNAPSI at week 28 that is improved by 100% (mNAPSI 100) compared to the subject's total-nail mNAPSI at week 0.

[0371] Embodiment 167: In Embodiment 159, the NAPSI is a total-nail NAPSI.

[0372] Embodiment 168: In Embodiment 167, the subject has a total fingernail NAPSI at week 28 that is improved by 75% (NAPSI 75) compared to the total fingernail NAPSI at week 0 of the subject.

[0373] Embodiment 169: In Embodiment 167, the subject has a total fingernail NAPSI at week 28 that is improved by 90% (NAPSI 90) compared to the total fingernail NAPSI at week 0 of the subject.

[0374] Embodiment 170: In Embodiment 167, the subject has a total fingernail NAPSI at week 28 that is improved by 100% (NAPSI 100) compared to the total fingernail NAPSI at week 0 of the subject.

[0375] Embodiment 171: In Embodiment 159, the subject has a Week 28 ViSENPsO score that is reduced by at least 2 points compared to the Week 0 ViSENPsO score of the subject.

[0376] Example 172: Use of the anti-IL-23p19 antibody hum13B8-b for the manufacture of a medicine to improve the nail pain numerical rating scale (NRS) score in subjects with nail psoriasis,

[0377] A first dose of the above-mentioned medicine is administered to the subject at week 0, a second dose of the above-mentioned medicine is administered to the subject at approximately week 4 after the first dose is administered to the subject, subsequent doses of the above-mentioned medicine are administered to the subject at approximately week 16 after the first dose is administered to the subject and thereafter at approximately every 12 weeks, and a final dose of the above-mentioned medicine is administered to the subject at approximately week 52 after the first dose is administered to the subject,

[0378] hum13B8-b is used for a light chain polypeptide comprising the amino acid sequence of SEQ ID NO. 1, and a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO. 2.

[0379] Embodiment 173: In Embodiment 172, the subject has a Week 0 NRS score of >3.

[0380] Embodiment 174: In Embodiment 172, the subject has a Week 28 NRS score that is reduced by >30% compared to the Week 0 NRS score of the subject.

[0381] Embodiment 175: As a use of the anti-IL-23p19 antibody hum13B8-b for the manufacture of a drug, the following:

[0382] (a) Modified Nail Psoriasis Severity Index (mNAPSI);

[0383] (b) Nail Psoriasis Severity Index (NAPSI);

[0384] (c) Visual Medical Scale for Assessing Severity of Nail Psoriasis (ViSENPsO); and / or

[0385] (d) One or more of the Nail Pain Rating Scale (NRS) scores

[0386] As for improvement in subjects with nail psoriasis,

[0387] A first dose of the above-mentioned medicine is administered to the subject at week 0, a second dose of the above-mentioned medicine is administered to the subject at approximately week 4 after the first dose is administered to the subject, subsequent doses of the above-mentioned medicine are administered to the subject at approximately week 16 after the first dose is administered to the subject and thereafter at approximately every 12 weeks, and a final dose of the above-mentioned medicine is administered to the subject at approximately week 52 after the first dose is administered to the subject,

[0388] hum13B8-b is used for a light chain polypeptide comprising the amino acid sequence of SEQ ID NO. 1, and a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO. 2.

[0389] Embodiment 176: In Embodiment 175, the subject has improved week 28 mNAPSI, NAPSI, ViSeNPsO and / or NRS compared to week 0 mNAPSI, NAPSI, ViSeNPsO and / or NRS of the subject.

[0390] Embodiment 177: Use of the anti-IL-23p19 antibody hum13B8-b for the manufacture of a medicine to increase the quality of life (QoL) in subjects with nail psoriasis,

[0391] A first dose of the above-mentioned medicine is administered to the subject at week 0, a second dose of the above-mentioned medicine is administered to the subject at approximately week 4 after the first dose is administered to the subject, subsequent doses of the above-mentioned medicine are administered to the subject at approximately week 16 after the first dose is administered to the subject and thereafter at approximately every 12 weeks, and a final dose of the above-mentioned medicine is administered to the subject at approximately week 52 after the first dose is administered to the subject,

[0392] hum13B8-b is used for a light chain polypeptide comprising the amino acid sequence of SEQ ID NO. 1, and a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO. 2.

[0393] Embodiment 178: Any one of Embodiments 159 to 177, wherein the nail psoriasis is fingernail psoriasis and / or toenail psoriasis.

[0394] Embodiment 179: Any one of Embodiments 159 to 177, wherein the subject has plaque psoriasis.

[0395] Embodiment 180: In any one of Embodiments 159 to 177, the first dose, the second dose, the subsequent dose, and the final dose are the same, for use.

[0396] Embodiment 181: In Embodiment 180, the first dose, second dose, subsequent dose, and final dose are about 100 mg of hum13B8-b.

[0397] Embodiment 182: Any one of Embodiments 159 to 177, wherein the first dose, second dose, subsequent dose, and final dose are hum13B8-b of about 5 mg to about 250 mg.

[0398] Embodiment 183: Any one of Embodiments 159 to 177, wherein the first dose, second dose, subsequent dose, and final dose are about 5 mg, about 25 mg, about 100 mg, or about 200 mg of hum13B8-b.

[0399] Embodiment 184: In any one of Embodiments 159 to 183, the medicine is administered subcutaneously to the subject.

[0400] Embodiment 185: In Embodiment 184, the above-mentioned medicine is administered to the subject by subcutaneous injection.

[0401] Embodiment 186: In Embodiment 184, the above-mentioned medicine is used to be administered to the abdominal area of ​​the subject.

[0402] Embodiment 187: An use in any one of Embodiments 159 to 186, wherein one or more doses of the medicine are administered to a subject using a pre-filled syringe that is ready for immediate use.

[0403] Embodiment 188: In Embodiment 187, the pre-filled syringe contains about 100 mg of hum13B8-b, an excipient, and a buffer solution.

[0404] Embodiment 189: In Embodiment 188, the pre-filled syringe further comprises L-histidine, L-histidine hydrochloride monohydrate, sucrose, and polysorbate 80 for use.

[0405] Embodiment 190: A method for treating nail psoriasis in a subject requiring treatment, wherein the method comprises the step of administering a therapeutically effective amount of an antibody comprising a light chain polypeptide having the amino acid sequence of SEQ ID NO. 1 and a heavy chain polypeptide having the amino acid sequence of SEQ ID NO. 2.

[0406] Examples

[0407] The claimed invention is further demonstrated by the following examples, which should not be construed as limiting. Those skilled in the art will recognize that the claimed invention may be practiced with variations of the disclosed materials, formulations, and methods, and that such variations are within the scope of the claimed invention.

[0408] Example 1: Anti-IL23p19 antibody treatment for nail psoriasis

[0409] subject

[0410] Eligible patients with moderate to severe plaque psoriasis and associated moderate to severe nail psoriasis were randomly assigned to one of the treatment groups in a 1:1 ratio as shown in Table 3.

[0411] [Table 3]

[0412] Treatment group

[0413]

[0414] A multicenter, randomized, double-blind, placebo-controlled clinical trial was conducted to evaluate the efficacy and safety of tildrakizumab in the treatment of moderate to severe onychomycosis. As provided in Table 4, the treatment was administered to subjects in Groups A and B. The duration of the clinical trial per subject was approximately 18 to 19 months, including a 52-week treatment period, and the total duration of the clinical trial was approximately 3 years.

[0415] [Table 4]

[0416] Treatment schedule

[0417]

[0418] Selection and Exclusion Criteria

[0419] Patients who met all the selection criteria in Table 5 were eligible to participate in the clinical trial, while patients were automatically excluded if any of the criteria in Table 6 applied. It is important to monitor indicators of fungal nail infection (Table 7) as they can interfere with the efficacy of treatment. Therefore, subjects with positive indicators of fungal infection were excluded from the clinical trial. Finally, there were specific classes of drugs that had to be discontinued prior to randomization for the clinical trial (Table 8), and some drugs were completely ineligible for use (Table 9).

[0420] [Table 5]

[0421] Selection Criteria :

[0422]

[0423]

[0424] [Table 6]

[0425] Exclusion Criteria:

[0426]

[0427]

[0428]

[0429] [Table 7]

[0430] Definition and Diagnosis of Fungal Nail Infections

[0431]

[0432] Patients who used any drug within the indicated withdrawal period prior to baseline randomization were excluded from the clinical trial.

[0433] [Table 8]

[0434] Drugs excluded before randomization

[0435]

[0436] The combination of drugs / therapies excluded during clinical trial treatment did not comply with the clinical trial protocol and had to be recorded in the eCRF.

[0437] [Table 9]

[0438] Excluded drugs and therapies

[0439]

[0440] Objectives and Evaluation Variables

[0441] Table 10 outlines the objectives and efficacy evaluation variables of the clinical trial.

[0442] [Table 10]

[0443] Purpose and Evaluation Variables of the Clinical Trial

[0444]

[0445]

[0446]

[0447] Example 2: Efficacy Evaluation

[0448] The efficacy evaluation was measured as described above and is presented in Table 10. The Nail Psoriasis Severity Index (NPSI) is first utilized by dividing the nails into quadrants using imaginary horizontal and vertical lines. Each nail receives a score for nail bed psoriasis (0–4) and nail matrix psoriasis (0–4) based on the presence of any one of the characteristics of nail psoriasis in the corresponding quadrant.

[0449] In each quadrant of the nail, nail matrix psoriasis is evaluated based on the presence of any one of the nail matrix features (punctate depressions, sucrose, red spots on the lunula, crumbling): 0 for absence, 1 for presence in the 1st quadrant of the nail, 2 for presence in the 2nd quadrant, 3 for presence in the 3rd quadrant, and 4 for presence in the 4th quadrant.

[0450] Nail bed psoriasis is evaluated by the presence of any one of the nail bed features, including onycholysis, microhemorrhage, subungual hyperkeratosis, and "oil droplets" (salmon spot dyspigmentation). Nail bed psoriasis is scored as 0 for absence, 1 for solitary in the 1st quadrant, 2 for the 2nd quadrant, 3 for the 3rd quadrant, and 4 for the 4th quadrant.

[0451] Each nail receives a matrix score and a nail bed score, and the sum is the score for that nail (0–8). Each nail is evaluated, and the sum of all nails is the total NAPSI score. The sum of all nail scores is 0–80.

[0452] Modified Nail Psoriasis Severity Index (mNAPSI)

[0453] The mNAPSI is an evaluation of nail abnormalities for each subject's nail, measured as previously described and presented in Table 1. Pinching, onycholysis, oil droplet dyspigmentation, and crumbling of each nail are graded on a scale of 0 to 3. Succulence, microhemorrhage, hyperkeratosis, and erythema of the lunula are graded as present or absent for each nail (see Table 1).

[0454] Doctor's Overall Evaluation of Skin - General (PGA-S)

[0455] A systematic review was conducted to evaluate the correlation between the Psoriasis Area and Severity Index (PASI) and the physician's overall assessment (PGA). Assessment scores were recorded, and the proportion of patients who achieved both a 75% reduction in PASI score (PASI 75) and a PGA of 0 or 1 (clear or nearly clear) at 8–16 weeks, 17–24 weeks, and over 24 weeks of treatment with the investigational drug was compared.

[0456] The two assessment tools are very closely correlated, except for the lower bound of treatment efficacy. The r(2) value for the correlation between the clear or nearly clear score on PGA and PASI 75 was 0.9157 at 8–16 weeks and 0.892 at 17–24 weeks. Since the two assessment tools substantially overlap, either one is sufficient to assess the severity of psoriasis in patients with moderate to severe disease.

[0457] Plaque psoriasis was evaluated using a physician's overall assessment of the skin on a 6-point scale to determine the overall severity of the subject's psoriatic lesions at a given time (Table 11).

[0458] The PGA-S was used to determine the overall severity of the subject's psoriasis lesions at a given time point. The overall lesions were graded for hypertrophy, erythema, and scaling based on the scale in Table 11 (below). The sum of the three scales was divided by 3 to obtain the final PGA score.

[0459] [Table 11]

[0460] Physician's Overall Assessment of Skin - Whole Body (PGA-S) Scoring System

[0461]

[0462] Psoriasis Area and Severity Index (PASI)

[0463] The Psoriasis Area and Severity Index (PASI) was used to determine treatment response (PASI 75, PASI 90, and PASI 100) in subjects with nail psoriasis. PASI includes scores for the percentage of body surface area (BSA) affected by erythema, hypertrophy, scalyness, and plaque psoriasis (Table 12).

[0464] PASI consists of two main steps: (1) a step of calculating the BSA covered by the lesion and (2) a step of evaluating the severity of the lesion, including evaluating the erythema (redness), induration (thickening), and scaling of the lesion.

[0465] All calculations are combined into a single PASI score ranging from 0 (no psoriasis on the body) to a maximum of 72 (the most severe case of psoriasis).

[0466] [Table 12]

[0467] Psoriasis Area and Severity Index (PASI)

[0468]

[0469] The efficacy of the anti-IL23p19 antibody is evaluated through primary and secondary endpoints as presented in Table 13.

[0470] [Table 13]

[0471] Efficacy Analysis

[0472]

[0473]

[0474]

[0475] Clinical trial design

[0476] Part 1: Double-blind placebo-controlled (Day 1–Week 28)

[0477] After a screening period of up to 28 days and on Day 1, all eligible subjects were randomized in a 1:1 ratio to receive either tildrakizumab 100 mg or placebo via subcutaneous injection at Week 0 (Day 1), Week 4, and Week 16. Subjects received the first dose of the investigational treatment within 24 hours of randomization. The duration of treatment for the double-blind, placebo-controlled part of the clinical trial was 28 weeks.

[0478] At Week 16, subjects experiencing a significant worsening of plaque psoriasis (defined as an increase of at least 2 in s-PGA relative to baseline measurements) were eligible for early withdrawal. Subjects selected for early withdrawal discontinued the investigational drug but completed the treatment end-visit evaluation, followed by the completion of the safety follow-up period. Subjects who entered early withdrawal were replaced to meet the target evaluable sample size for the analysis of the primary endpoint.

[0479] An optional interim analysis was performed that may include unblinded sample size reestimation (SSRE). The sample size of the clinical trial may increase as a result of such SSRE. If the sample size increases, the total sample size of the clinical trial will not exceed a total of approximately 282 randomized subjects.

[0480] Part 2: Extension of Double-Blind Active Therapy (Weeks 28–52)

[0481] At week 28, subjects initially randomized to receive placebo would be switched to receive tildrakizumab 100 mg at weeks 28, 32, and 44. Subjects initially randomized to receive tildrakizumab 100 mg continued to receive tildrakizumab at weeks 28, 40, and 52. To maintain blinding, subjects in both treatment groups received the corresponding placebo injection at the specified time points.

[0482] At Week 28, subjects who experienced a significant worsening of plaque psoriasis (defined as an increase of at least 2 in s-PGA from baseline measurements) discontinued treatment. Subjects who did not meet this criterion at Week 28 continued to receive tildrakizumab in Part 2 as previously described.

[0483] Part 3: Observational Safety Follow-up (Weeks 52–72)

[0484] After Week 52 (or before Week 52 if the investigational treatment was terminated early), administration of the investigational treatment was discontinued, and all subjects, including those who discontinued early from Parts 1 and 2, entered a 20-week safety follow-up period to observe safety and tolerability for 20 weeks following the last administration of the investigational treatment. During the follow-up period, subjects continued to receive only the combination drug approved in the clinical trial, but were also administered other appropriate therapy in case of safety concerns or significant exacerbation of psoriasis. Subjects did not receive the investigational treatment during the follow-up period.

[0485] The clinical trial may have a primary analysis performed when the last subject completes the 28th week visit, and a final analysis performed when the last subject completes the clinical trial.

[0486] Subjects who withdraw from the clinical trial will receive an evaluation corresponding to the final evaluation of the part of the clinical trial they are leaving. Subjects who discontinue the trial treatment at any time (separate from the withdrawal of subject consent) will complete the EoT (Week 52) evaluation approximately 4 weeks after the last administration of the trial treatment and enter a 20-week safety follow-up. Subjects who withdraw from the clinical trial during Part 3 will receive the Week 72 (End of Study [EoS]] evaluation approximately 4 weeks after the last visit.

[0487] Scientific basis of clinical trial design

[0488] This study is a randomized, double-blind, placebo-controlled, Phase 3 clinical trial to evaluate the efficacy and safety of tildrakizumab administered by subcutaneous injection in subjects with moderate to severe onychomycosis. In this study, tildrakizumab will be compared to placebo.

[0489] The clinical trial was designed in four distinct phases (screening, double-blind placebo-controlled period, double-blind active treatment period, and observational safety follow-up period).

[0490] This allows for the scientific evaluation of efficacy at week 28. A 52-week treatment period is expected to provide an adequate amount of time to evaluate the safety and efficacy of tildrakizumab in subjects with nail psoriasis.

[0491] Discontinuation of test drug administration

[0492] Subjects could voluntarily discontinue clinical trial treatment at any time for any reason and enter a 20-week drug-free period or withdraw completely from the clinical trial. Subjects who entered the drug-free period underwent an end-of-time (EoT) evaluation at Week 52, approximately four weeks after the administration of the last dose of the study treatment.

[0493] Clinical trial treatment was discontinued in the following situations listed in Table 14 below, and further steps should be discussed with the medical monitor. Subjects discontinued from the clinical trial could not be replaced. Additionally, subjects who withdrew from the clinical trial had to undergo an evaluation corresponding to the termination evaluation of the part of the clinical trial they were leaving. The Week 52 Evaluation (EoT) was performed approximately 4 weeks after the administration of the last dose of clinical trial treatment. Refer to the activity schedule for data to be collected and additional evaluations to be completed at the time of treatment discontinuation and follow-up.

[0494] [Table 14]

[0495] Cases of disqualification in therapeutic clinical trials

[0496]

[0497] Temporary suspension

[0498] Table 15 presents cases where temporary discontinuation of clinical trial treatment occurs.

[0499] [Table 15]

[0500] Cause of temporary suspension

[0501]

[0502] Discontinuation or withdrawal of the clinical trial for the subject

[0503] The subject could voluntarily withdraw their consent to participate in the clinical trial at any time for any reason.

[0504] Statistical considerations

[0505] The primary efficacy endpoint of this clinical trial was the proportion of subjects who achieved a 75% or greater improvement in total mNAPSI from baseline at week 28. The key secondary efficacy endpoint was the proportion of subjects who achieved a reduction of 2 points or more from baseline in their "0 - Normal" or "1 - Minimal Nail Psoriasis" score as measured by ViSENPsO at week 28. For each endpoint, the tildrakizumab 100 mg dose was compared to placebo at week 28.

[0506] Type I errors across the entire clinical trial were controlled for primary and secondary efficacy endpoints using a step-down sequential procedure to achieve an overall Type I error rate at the 0.05 level. The hierarchical order for testing the endpoints followed the sequence presented below:

[0507] 1. The proportion of subjects achieving at least a 75% improvement in total mNAPSI from baseline at Week 28 (primary endpoint).

[0508] 2. "0-Normal" or "1-Minimum Nail Psoriasis" score as measured by ViSENPsO at Week 28 and the proportion of subjects with a reduction of at least 2 points from baseline. (Primary secondary endpoint).

[0509] 3. Change in total nail mNAPSI score from baseline at Week 28.

[0510] 4. Change in total nail NAPSI score from baseline at week 28.

[0511] 5. Percentage of subjects achieving a total nail NAPSI of 75 at week 28.

[0512] 6. Percentage of subjects achieving a total nail mNAPSI of 90 at week 28.

[0513] 7. Percentage of subjects who achieved a total nail NAPSI of 90 at week 28.

[0514] 8. Percentage of subjects who achieved a total nail mNAPSI of 100 at week 28.

[0515] 9. Percentage of subjects who achieved a total nail NAPSI of 100 at week 28.

[0516] population for analysis

[0517] Define the analysis set of Table 16 for analysis.

[0518] [Table 16]

[0519] Analysis set

[0520]

[0521] Statistical analysis

[0522] As used herein, the term "baseline" refers to the last observation of the endpoint of interest prior to the first administration of the clinical trial treatment (including non-scheduled visits). For numerical variables, the change from baseline was calculated as the difference between the post-baseline value and the corresponding baseline value.

[0523] Example 3: Phase 3b clinical trial for nail psoriasis at week 28

[0524] mNAPSI 75 response evaluation was performed at week 28 with a sample size of 96 patients (99 patients at final enrollment). ViSENPsO response was also evaluated at week 28.

[0525] The demographics of the clinical trial population are summarized in Table 17.

[0526] [Table 17]

[0527] Patient demographics

[0528]

[0529] In the ITT and NRI cohorts, among subjects treated with tildrakizumab 100 mg, 25.5% achieved an mNAPSI 75 response and 29.4% achieved a ViSENPsO response at week 28 (Table 18). In the ITT and OC cohorts, 30.2% of subjects treated with tildrakizumab 100 mg achieved an mNAPSI 75 (Table 19). Approximately 33.3% of subjects in both the PPS / NRI and PPS / OC populations experienced an mNAPSI 75 response (Table 20). Additionally, 60.6% of subjects experienced a 30% reduction in nail pain, 58.7% achieved a PASI 75, 33.3% achieved a PASI 90 response, and 25.5% achieved a PASI 100 response (Table 20). In addition, 51% of subjects experienced a reduction of at least 2 points compared to the baseline PGA score (Table 20). Competitive treatments such as adalimumab, guselkizumab, risankizumab, and brodalumab were also evaluated for overall efficacy between the treatment and placebo groups (Table 23). Efficacy was evaluated at weeks 12, 16, 24, or 26 using a physician's overall assessment of the nails and the Modified Nail Psoriasis Severity Index (Table 23).

[0530] Tildrakizumab 100 mg demonstrated high tolerability with low rates of drug-related after-treatment adverse events (TEAEs) or serious TEAEs (Table 21). More specifically, infections, parasitic infections, and injection-related reactions were experienced during treatment (Table 22).

[0531] Tildrakizumab 100 mg treatment for nail psoriasis demonstrated efficacy and tolerability at week 28, and there were no serious drug-related adverse events, discontinuations, or deaths at week 28 of treatment.

[0532] [Table 18]

[0533] Efficacy measured as the primary endpoint

[0534]

[0535] [Table 19]

[0536] Auxiliary analysis of efficacy results

[0537]

[0538] [Table 20]

[0539] Efficacy measured as a secondary evaluation variable

[0540]

[0541] [Table 21]

[0542] Adverse Events (SAF)

[0543]

[0544] [Table 22]

[0545] Subjects who developed drug-related TEAEs

[0546]

[0547] [Table 23]

[0548] Reaction rate of competitor molecules

[0549]

Claims

Claim 1 A method for treating nail psoriasis in a subject requiring treatment, wherein the method comprises the step of administering a therapeutically effective amount of the anti-IL-23p19 antibody hum13B8-b to the subject, wherein a first dose of hum13B8-b is administered to the subject at week 0, a second dose of hum13B8-b is administered to the subject at approximately week 4 after the first dose is administered to the subject, subsequent doses of hum13B8-b are administered to the subject at approximately week 16 after the first dose is administered to the subject and thereafter at approximately every 12 weeks, and a final dose of hum13B8-b is administered to the subject at approximately week 52 after the first dose is administered to the subject, wherein hum13B8-b comprises a light chain polypeptide comprising the amino acid sequence of SEQ ID NO. 1 and a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO.

2. Claim 2 In claim 1, the nail psoriasis is fingernail psoriasis and / or toenail psoriasis, method. Claim 3 In paragraph 1, the method wherein the subject has plaque psoriasis. Claim 4 In paragraph 1, the first dose, the second dose, the subsequent dose, and the final dose are the same, method. Claim 5 A method according to paragraph 2, wherein the first dose, second dose, subsequent dose, and final dose are about 100 mg. Claim 6 A method according to paragraph 2, wherein the first dose, the second dose, the subsequent dose, and the final dose are about 5 mg to about 250 mg. Claim 7 A method according to claim 1, wherein the first dose, the second dose, and the subsequent doses are about 5 mg, about 25 mg, about 100 mg, and about 200 mg. Claim 8 A method of subcutaneously administering the anti-IL-23p19 antibody hum13B8-b to the subject in accordance with claim 1. Claim 9 A method of administering the anti-IL-23p19 antibody hum13B8-b to the subject by subcutaneous injection in accordance with claim 8. Claim 10 In claim 8, a method of administering the anti-IL-23p19 antibody hum13B8-b to the abdominal area of ​​the subject. Claim 11 A method according to claim 1, wherein the administration of the anti-IL-23p19 antibody hum13B8-b results in one or more of the following: (a) improvement in the total-modified nail psoriasis severity index (mNAPSI) in the subject; (b) improvement in the score of the scale for assessing nail psoriasis severity (ViSENPsO) in the subject; and / or (c) improvement in the total nail psoriasis severity index (NAPSI) in the subject. Claim 12 In paragraph 11, the subject has a total mNAPSI at week 0 of >20 and / or a Visual Medical Scale for Assessment of Nail Psoriasis (ViSENPsO) score of >3 at week 0, method. Claim 13 In claim 11, the method wherein the subject has a 28-week mNAPSI that is improved by >75% (mNAPSI 75) compared to the subject's 0-week mNAPSI. Claim 14 In claim 11, the method wherein the subject has a 28-week mNAPSI that is improved by >90% (mNAPSI 90) compared to the subject's 0-week mNAPSI. Claim 15 A method according to claim 11, wherein the subject has a 28-week mNAPSI that is improved by 100% (mNAPSI 100) compared to the subject's 0-week mNAPSI. Claim 16 A method according to claim 11, wherein the subject has a 28-week mNAPSI that is improved by 100% (mNAPSI 100) compared to the subject's 0-week mNAPSI. Claim 17 In paragraph 16, the method wherein the subject has a total-nail mNAPSI at week 28 that is improved by 90% (mNAPSI 90) compared to the subject's total-nail mNAPSI at week 0. Claim 18 In paragraph 16, the method wherein the subject has a total-nail mNAPSI at week 28 that is improved by 100% (mNAPSI 100) compared to the subject's total-nail mNAPSI at week 0. Claim 19 In paragraph 18, the above NAPSI is a total-nail NAPSI, method. Claim 20 In paragraph 18, the above NAPSI is a total-nail NAPSI, method. Claim 21 In paragraph 19, the method wherein the subject has a total nail NAPSI at week 28 that is improved by 90% (NAPSI 90) compared to the subject's total nail NAPSI at week 0. Claim 22 In paragraph 19, the method wherein the subject has a total nail NAPSI at week 28 that is improved by 100% (NAPSI 100) compared to the subject's total nail NAPSI at week 0. Claim 23 In claim 11, the method wherein the subject has a Week 28 ViSENPsO score that is at least 2 points lower than the subject's Week 0 ViSENPsO score. Claim 24 A method according to claim 1, wherein the administration of the anti-IL-23p19 antibody hum13B8-b results in an improvement in the nail pain numerical rating scale (NRS) score in the subject. Claim 25 In paragraph 24, the above subject is a method in which the Week 0 NRS score is >3. Claim 26 In paragraph 24, the method wherein the subject has a Week 28 NRS score that is reduced by >30% compared to the subject's Week 0 NRS score. Claim 27 The method of claim 1, wherein the administration of the anti-IL-23p19 antibody hum13B8-b results in one or more of the following: (a) improvement in the modified nail psoriasis severity index (mNAPSI) in the subject; (b) improvement in the nail psoriasis severity index (NAPSI) in the subject; (c) improvement in the visual medical scale for assessing nail psoriasis severity (ViSENPsO) in the subject; and / or (d) improvement in the nail pain numerical rating scale (NRS) score in the subject. Claim 28 In claim 27, the method wherein the subject has improved week 28 mNAPSI, NAPSI, ViSeNPsO, and / or NRS compared to the subject's week 0 mNAPSI, NAPSI, ViSeNPsO, and / or NRS. Claim 29 A method according to claim 1, wherein the administration of the anti-IL-23p19 antibody hum13B8-b increases the quality of life (QoL) in the subject. Claim 30 A method according to any one of claims 1 to 29, wherein one or more doses of the anti-IL-23p19 antibody hum13B8-b are administered to the subject using a pre-filled syringe available for immediate use. Claim 31 In paragraph 30, the method wherein the pre-filled syringe contains about 100 mg of hum13B8-b, an excipient, and a buffer. Claim 32 In claim 31, the method wherein the pre-filled syringe further comprises L-histidine, L-histidine hydrochloride monohydrate, sucrose, and polysorbate 80. Claim 33 Next: (a) Total-modified Nail Psoriasis Severity Index (mNAPSI); (b) Scale for Assessing Nail Psoriasis Severity (ViSENPsO) score; and / or (c) a method for improving one or more of the Total Nail Psoriasis Severity Index (NAPSI) in a subject with nail psoriasis, wherein the method comprises the step of administering a therapeutically effective amount of the anti-IL-23p19 antibody hum13B8-b to the subject, wherein a first dose of hum13B8-b is administered to the subject at week 0, a second dose of hum13B8-b is administered to the subject approximately 4 weeks after the first dose is administered to the subject, subsequent doses of hum13B8-b are administered to the subject approximately 16 weeks after the first dose is administered to the subject and thereafter every approximately 12 weeks, and a final dose of hum13B8-b is administered to the subject approximately 52 weeks after the first dose is administered to the subject, and hum13B8-b comprises a light chain polypeptide comprising the amino acid sequence of SEQ ID NO. 1 and a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO. 2 Method including. Claim 34 In paragraph 33, the subject has a total mNAPSI at week 0 >20 and / or a Visual Medical Scale for Assessment of Nail Psoriasis (ViSENPsO) score of >3 at week 0, method. Claim 35 In paragraph 33, the method wherein the subject has a 28-week mNAPSI that is improved by >75% (mNAPSI 75) compared to the subject's 0-week mNAPSI. Claim 36 In paragraph 33, the method wherein the subject has a 28-week mNAPSI that is improved by >90% (mNAPSI 90) compared to the subject's 0-week mNAPSI. Claim 37 In paragraph 33, the method wherein the subject has a 28-week mNAPSI that is improved by 100% (mNAPSI 100) compared to the subject's 0-week mNAPSI. Claim 38 In paragraph 33, the method wherein the total mNAPSI is the total-nail mNAPSI. Claim 39 In paragraph 38, the method wherein the subject has a total-nail mNAPSI at week 28 that is improved by 90% (mNAPSI 90) compared to the subject's total-nail mNAPSI at week 0. Claim 40 In paragraph 38, the method wherein the subject has a total-nail mNAPSI at week 28 that is improved by 100% (mNAPSI 100) compared to the subject's total-nail mNAPSI at week 0. Claim 41 In paragraph 33, the above NAPSI is a total-nail NAPSI, method. Claim 42 In paragraph 41, the method wherein the subject has a total nail NAPSI at week 28 that is improved by 75% (NAPSI 75) compared to the subject's total nail NAPSI at week 0. Claim 43 In paragraph 41, the method wherein the subject has a total nail NAPSI at week 28 that is improved by 90% (NAPSI 90) compared to the subject's total nail NAPSI at week 0. Claim 44 In paragraph 41, the method wherein the subject has a total nail NAPSI at week 28 that is improved by 100% (NAPSI 100) compared to the subject's total nail NAPSI at week 0. Claim 45 In paragraph 33, the method wherein the subject has a Week 28 ViSENPsO score that is at least 2 points lower than the subject's Week 0 ViSENPsO score. Claim 46 A method for improving the nail pain numerical rating scale (NRS) score in a subject with nail psoriasis, wherein the method comprises the step of administering a therapeutically effective amount of the anti-IL-23p19 antibody hum13B8-b to the subject, wherein a first dose of hum13B8-b is administered to the subject at week 0, a second dose of hum13B8-b is administered to the subject at approximately week 4 after the first dose is administered to the subject, subsequent doses of hum13B8-b are administered to the subject at approximately week 16 after the first dose is administered to the subject and thereafter at every 12 weeks, and a final dose of hum13B8-b is administered to the subject at approximately week 52 after the first dose is administered to the subject. hum13B8-b comprises a light chain polypeptide comprising the amino acid sequence of SEQ ID NO. 1, and a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO.

2. Claim 47 In Clause 46, the above subject is a method in which the Week 0 NRS score is >3. Claim 48 In Clause 46, the above subject is a method in which the Week 0 NRS score is >3. Claim 49 Next: (a) Modified Nail Psoriasis Severity Index (mNAPSI); (b) Nail Psoriasis Severity Index (NAPSI); (c) Visual Medical Scale for Assessing Nail Psoriasis Severity (ViSENPsO); and / or (d) a method for improving one or more of the nail pain numerical rating scale (NRS) scores in a subject with nail psoriasis, wherein the method comprises the step of administering a therapeutically effective amount of the anti-IL-23p19 antibody hum13B8-b to the subject, wherein a first dose of hum13B8-b is administered to the subject at week 0, a second dose of hum13B8-b is administered to the subject approximately 4 weeks after the first dose is administered to the subject, subsequent doses of hum13B8-b are administered to the subject approximately 16 weeks after the first dose is administered to the subject and thereafter every approximately 12 weeks, and a final dose of hum13B8-b is administered to the subject approximately 52 weeks after the first dose is administered to the subject, and hum13B8-b comprises a light chain polypeptide comprising the amino acid sequence of SEQ ID NO. 1 and a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO.

2. Purpose. Claim 50 In claim 49, the method wherein the subject has improved week 28 mNAPSI, NAPSI, ViSeNPsO, and / or NRS compared to the subject's week 0 mNAPSI, NAPSI, ViSeNPsO, and / or NRS. Claim 51 A method for increasing the quality of life (QoL) in a subject with nail psoriasis, wherein the method comprises the step of administering a therapeutically effective amount of the anti-IL-23p19 antibody hum13B8-b to the subject, wherein a first dose of hum13B8-b is administered to the subject at week 0, a second dose of hum13B8-b is administered to the subject at approximately week 4 after the first dose is administered to the subject, subsequent doses of hum13B8-b are administered to the subject at approximately week 16 after the first dose is administered to the subject and thereafter at approximately every 12 weeks, and a final dose of hum13B8-b is administered to the subject at approximately week 52 after the first dose is administered to the subject, wherein hum13B8-b comprises a light chain polypeptide comprising the amino acid sequence of SEQ ID NO. 1 and a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO.

2. Claim 52 A method according to any one of claims 33 to 51, wherein the nail psoriasis is fingernail psoriasis and / or toenail psoriasis. Claim 53 A method according to any one of paragraphs 33 to 51, wherein the subject has plaque psoriasis. Claim 54 A method in which, in any one of paragraphs 33 to 51, the first dose, the second dose, the subsequent dose, and the final dose are the same. Claim 55 A method according to paragraph 54, wherein the first dose, second dose, subsequent dose, and final dose are about 100 mg. Claim 56 A method according to any one of claims 33 to 51, wherein the first dose, the second dose, the subsequent dose, and the final dose are about 5 mg to about 250 mg. Claim 57 A method according to any one of claims 33 to 51, wherein the first dose, second dose, subsequent dose, and final dose are about 5 mg, about 25 mg, about 100 mg, or about 200 mg. Claim 58 A method of subcutaneously administering the anti-IL-23p19 antibody hum13B8-b to the subject in any one of claims 33 to 57. Claim 59 In claim 58, a method of administering the anti-IL-23p19 antibody hum13B8-b to the subject by subcutaneous injection. Claim 60 In claim 58, a method of administering the anti-IL-23p19 antibody hum13B8-b to the abdominal area of ​​the subject. Claim 61 A method according to any one of claims 33 to 60, wherein one or more doses of the anti-IL-23p19 antibody hum13B8-b are administered to the subject using a pre-filled syringe available for immediate use. Claim 62 In paragraph 61, the method wherein the pre-filled syringe contains about 100 mg of hum13B8-b, an excipient, and a buffer. Claim 63 In paragraph 62, the method wherein the pre-filled syringe further comprises L-histidine, L-histidine hydrochloride monohydrate, sucrose, and polysorbate 80. Claim 64 A pharmaceutical composition of an anti-IL-23p19 antibody hum13B8-b for treating nail psoriasis in a subject, wherein a first dose of the pharmaceutical composition is administered to the subject at week 0, a second dose of the pharmaceutical composition is administered to the subject at approximately week 4 after the first dose is administered to the subject, subsequent doses of the pharmaceutical composition are administered to the subject at approximately week 16 after the first dose is administered to the subject and thereafter at approximately every 12 weeks, and a final dose of the pharmaceutical composition is administered to the subject at approximately week 52 after the first dose is administered to the subject, wherein hum13B8-b comprises a light chain polypeptide comprising the amino acid sequence of SEQ ID NO. 1, and a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO.

2. Claim 65 A pharmaceutical composition according to claim 64, wherein the nail psoriasis is fingernail psoriasis and / or toenail psoriasis. Claim 66 In paragraph 64, the above-mentioned subject has plaque psoriasis, and the pharmaceutical composition. Claim 67 In paragraph 64, the first dose, the second dose, the subsequent dose, and the final dose are the same, pharmaceutical composition. Claim 68 A pharmaceutical composition according to claim 65, wherein the first dose, second dose, subsequent dose, and final dose are about 100 mg of hum13B8-b. Claim 69 A pharmaceutical composition according to claim 64, wherein the first dose, second dose, subsequent dose, and final dose are about 5 mg to about 250 mg of hum13B8-b. Claim 70 A pharmaceutical composition according to claim 64, wherein the first dose, the second dose, and subsequent doses are about 5 mg, about 25 mg, about 100 mg, or about 200 mg of hum13B8-b. Claim 71 In paragraph 64, the above pharmaceutical composition is a pharmaceutical composition administered subcutaneously to the subject. Claim 72 In paragraph 71, the pharmaceutical composition is a pharmaceutical composition administered to the subject by subcutaneous injection. Claim 73 In paragraph 71, the pharmaceutical composition is a pharmaceutical composition administered to the abdominal area of ​​the subject. Claim 74 In paragraph 64, the administration of the pharmaceutical composition results in one or more of the following: (a) improvement in the total-modified nail psoriasis severity index (mNAPSI) in the subject; (b) improvement in the score of the scale for assessing nail psoriasis severity (ViSENPsO) in the subject; and / or (c) improvement in the total nail psoriasis severity index (NAPSI) in the subject. Claim 75 A pharmaceutical composition in which the subject has a total mNAPSI at week 0 >20 and / or a Visual Medical Scale for Assessment of Nail Psoriasis (ViSENPsO) score of >3 at week 0. Claim 76 A pharmaceutical composition according to claim 74, wherein the subject has a 28-week mNAPSI improved by >75% (mNAPSI 75) compared to the subject's 0-week mNAPSI. Claim 77 A pharmaceutical composition according to claim 74, wherein the subject has a 28-week mNAPSI improved by >90% (mNAPSI 90) compared to the subject's 0-week mNAPSI. Claim 78 A pharmaceutical composition according to claim 74, wherein the subject has a 28-week mNAPSI improved by 100% (mNAPSI 100) compared to the subject's 0-week mNAPSI. Claim 79 A pharmaceutical composition according to claim 74, wherein the subject has a 28-week mNAPSI improved by 100% (mNAPSI 100) compared to the subject's 0-week mNAPSI. Claim 80 A pharmaceutical composition according to claim 79, wherein the subject has a total nail mNAPSI at week 28 that is improved by 90% (mNAPSI 90) compared to the subject's total nail mNAPSI at week 0. Claim 81 A pharmaceutical composition according to claim 79, wherein the subject has a total-nail mNAPSI at week 28 that is improved by 100% (mNAPSI 100) compared to the subject's total-nail mNAPSI at week 0. Claim 82 In paragraph 81, a pharmaceutical composition in which NAPSI is a total-nail NAPSI. Claim 83 A pharmaceutical composition according to claim 82, wherein the subject has a total nail NAPSI at week 28 that is improved by 75% (NAPSI 75) compared to the subject's total nail NAPSI at week 0. Claim 84 A pharmaceutical composition according to claim 82, wherein the subject has a total nail NAPSI at week 28 that is improved by 90% (NAPSI 90) compared to the subject's total nail NAPSI at week 0. Claim 85 A pharmaceutical composition according to claim 82, wherein the subject has a total nail NAPSI at week 28 that is improved by 100% (NAPSI 100) compared to the subject's total nail NAPSI at week 0. Claim 86 A pharmaceutical composition according to claim 74, wherein the subject has a Week 28 ViSENPsO score that is reduced by at least 2 points compared to the Week 0 ViSENPsO score of the subject. Claim 87 In paragraph 64, the pharmaceutical composition such that administration of the above pharmaceutical composition results in an improvement in the nail pain numerical rating scale (NRS) score in the subject. Claim 88 In Clause 87, the above subject is a pharmaceutical composition in which the Week 0 NRS score is >3. Claim 89 A pharmaceutical composition according to claim 87, wherein the subject has a Week 28 NRS score reduced by >30% compared to the Week 0 NRS score of the subject. Claim 90 In paragraph 64, the administration of the pharmaceutical composition results in one or more of the following: (a) improvement in the modified nail psoriasis severity index (mNAPSI) in the subject; (b) improvement in the nail psoriasis severity index (NAPSI) in the subject; (c) improvement in the visual medical scale for assessing nail psoriasis severity (ViSENPsO) in the subject; and / or (d) improvement in the nail pain numerical rating scale (NRS) score in the subject. Claim 91 A pharmaceutical composition according to claim 90, wherein the subject has improved week 28 mNAPSI, NAPSI, ViSeNPsO and / or NRS compared to the subject's week 0 mNAPSI, NAPSI, ViSeNPsO and / or NRS. Claim 92 In paragraph 64, the administration of the above pharmaceutical composition increases the quality of life (QoL) in the subject. Claim 93 A pharmaceutical composition according to any one of claims 64 to 92, wherein one or more doses of the pharmaceutical composition are administered to the subject using a pre-filled syringe available for immediate use. Claim 94 In paragraph 93, the pre-filled syringe is a pharmaceutical composition containing about 100 mg of hum13B8-b, an excipient, and a buffer. Claim 95 In claim 94, the pre-filled syringe further comprises L-histidine, L-histidine hydrochloride monohydrate, sucrose, and polysorbate 80, a pharmaceutical composition. Claim 96 As a pharmaceutical composition of the anti-IL-23p19 antibody hum13B8-b, the following: (a) Total-Modified Nail Psoriasis Severity Index (mNAPSI); (b) Scale for Assessing Nail Psoriasis Severity (ViSENPsO) score; and / or (c) for improving one or more of the Total Nail Psoriasis Severity Index (NAPSI) in a subject with nail psoriasis, wherein a first dose of the pharmaceutical composition is administered to the subject at week 0, a second dose of the pharmaceutical composition is administered to the subject at approximately week 4 after the first dose is administered to the subject, subsequent doses of the pharmaceutical composition are administered to the subject at approximately week 16 after the first dose is administered to the subject and thereafter at approximately every 12 weeks, and a final dose of the pharmaceutical composition is administered to the subject at approximately week 52 after the first dose is administered to the subject, and hum13B8-b is a pharmaceutical composition comprising a light chain polypeptide comprising the amino acid sequence of SEQ ID NO. 1, and a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO.

2. Claim 97 A pharmaceutical composition according to claim 96, wherein the subject has a total mNAPSI at week 0 >20 and / or a Visual Medical Scale for Assessment of Nail Psoriasis (ViSENPsO) score at week 0 >3. Claim 98 A pharmaceutical composition according to claim 96, wherein the subject has a 28-week mNAPSI improved by >75% (mNAPSI 75) compared to the 0-week mNAPSI of the subject. Claim 99 A pharmaceutical composition according to claim 96, wherein the subject has a 28-week mNAPSI improved by >90% (mNAPSI 90) compared to the subject's 0-week mNAPSI. Claim 100 A pharmaceutical composition according to claim 96, wherein the subject has a 28-week mNAPSI improved by 100% (mNAPSI 100) compared to the subject's 0-week mNAPSI. Claim 101 In paragraph 96, a pharmaceutical composition in which total-mNAPSI is total-nail mNAPSI. Claim 102 A pharmaceutical composition according to claim 101, wherein the subject has a total nail mNAPSI at week 28 that is improved by 90% (mNAPSI 90) compared to the subject's total nail mNAPSI at week 0. Claim 103 A pharmaceutical composition according to claim 101, wherein the subject has a total-nail mNAPSI at week 28 that is improved by 100% (mNAPSI 100) compared to the subject's total-nail mNAPSI at week 0. Claim 104 In paragraph 96, a pharmaceutical composition in which NAPSI is a total-nail NAPSI. Claim 105 A pharmaceutical composition according to claim 104, wherein the subject has a total nail NAPSI at week 28 that is improved by 75% (NAPSI 75) compared to the subject's total nail NAPSI at week 0. Claim 106 A pharmaceutical composition according to claim 104, wherein the subject has a total nail NAPSI at week 28 that is improved by 90% (NAPSI 90) compared to the subject's total nail NAPSI at week 0. Claim 107 A pharmaceutical composition according to claim 104, wherein the subject has a total nail NAPSI at week 28 that is improved by 100% (NAPSI 100) compared to the subject's total nail NAPSI at week 0. Claim 108 A pharmaceutical composition according to claim 96, wherein the subject has a Week 28 ViSENPsO score that is reduced by at least 2 points compared to the Week 0 ViSENPsO score of the subject. Claim 109 A pharmaceutical composition of the anti-IL-23p19 antibody hum13B8-b for improving the nail pain numerical rating scale (NRS) score in subjects with nail psoriasis, wherein a first dose of the pharmaceutical composition is administered to the subject at week 0, a second dose of the pharmaceutical composition is administered to the subject at approximately week 4 after the first dose is administered to the subject, subsequent doses of the pharmaceutical composition are administered to the subject at approximately week 16 after the first dose is administered to the subject and thereafter at approximately every 12 weeks, and a final dose of the pharmaceutical composition is administered to the subject at approximately week 52 after the first dose is administered to the subject, wherein hum13B8-b comprises a light chain polypeptide comprising the amino acid sequence of SEQ ID NO. 1, and a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO.

2. Claim 110 In Clause 109, the above subject is a pharmaceutical composition having a Week 0 NRS score >3. Claim 111 A pharmaceutical composition according to claim 109, wherein the subject has a Week 28 NRS score reduced by >30% compared to the Week 0 NRS score of the subject. Claim 112 As a pharmaceutical composition of the anti-IL-23p19 antibody hum13B8-b, the following: (a) modified onysoriasis severity index (mNAPSI); (b) onysoriasis severity index (NAPSI); (c) visual medical scale for assessing onysoriasis severity (ViSENPsO); and / or (d) for improving one or more of the nail pain numerical rating scale (NRS) scores in a subject with nail psoriasis, wherein a first dose of the pharmaceutical composition is administered to the subject at week 0, a second dose of the pharmaceutical composition is administered to the subject at approximately week 4 after the first dose is administered to the subject, subsequent doses of the pharmaceutical composition are administered to the subject at approximately week 16 after the first dose is administered to the subject and thereafter at approximately every 12 weeks, and a final dose of the pharmaceutical composition is administered to the subject at approximately week 52 after the first dose is administered to the subject, and hum13B8-b is a pharmaceutical composition comprising a light chain polypeptide comprising the amino acid sequence of SEQ ID NO. 1, and a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO.

2. Claim 113 A pharmaceutical composition according to claim 112, wherein the subject has improved week 28 mNAPSI, NAPSI, ViSeNPsO and / or NRS compared to the subject's week 0 mNAPSI, NAPSI, ViSeNPsO and / or NRS. Claim 114 A pharmaceutical composition of the anti-IL-23p19 antibody hum13B8-b for increasing the quality of life (QoL) in subjects with nail psoriasis, wherein a first dose of the pharmaceutical composition is administered to the subject at week 0, a second dose of the pharmaceutical composition is administered to the subject at approximately week 4 after the first dose is administered to the subject, subsequent doses of the pharmaceutical composition are administered to the subject at approximately week 16 after the first dose is administered to the subject and thereafter at approximately every 12 weeks, and a final dose of the pharmaceutical composition is administered to the subject at approximately week 52 after the first dose is administered to the subject, wherein hum13B8-b comprises a light chain polypeptide comprising the amino acid sequence of SEQ ID NO. 1, and a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO.

2. Claim 115 A pharmaceutical composition according to any one of claims 96 to 114, wherein the nail psoriasis is fingernail psoriasis and / or toenail psoriasis. Claim 116 A pharmaceutical composition according to any one of claims 96 to 114, wherein the subject has plaque psoriasis. Claim 117 A pharmaceutical composition according to any one of claims 96 to 114, wherein the first dose, the second dose, the subsequent dose, and the final dose are the same. Claim 118 A pharmaceutical composition according to claim 117, wherein the first dose, second dose, subsequent dose, and final dose are about 100 mg of hum13B8-b. Claim 119 A pharmaceutical composition according to any one of claims 96 to 114, wherein the first dose, the second dose, the subsequent dose, and the final dose are about 5 mg to about 250 mg of hum13B8-b. Claim 120 A pharmaceutical composition according to any one of claims 96 to 114, wherein the first dose, the second dose, the subsequent dose, and the final dose are about 5 mg, about 25 mg, about 100 mg, or about 200 mg of hum13B8-b. Claim 121 A pharmaceutical composition according to any one of claims 96 to 120, wherein the pharmaceutical composition is administered subcutaneously to the subject. Claim 122 In claim 121, the pharmaceutical composition is a pharmaceutical composition administered to the subject by subcutaneous injection. Claim 123 In paragraph 121, the pharmaceutical composition is a pharmaceutical composition administered to the abdominal area of ​​the subject. Claim 124 A pharmaceutical composition according to any one of claims 96 to 123, wherein one or more doses of the pharmaceutical composition are administered to the subject using a pre-filled syringe available for immediate use. Claim 125 In claim 124, the above-mentioned pre-filled syringe is a pharmaceutical composition containing about 100 mg of hum13B8-b, an excipient, and a buffer. Claim 126 In claim 125, the pre-filled syringe further comprises L-histidine, L-histidine hydrochloride monohydrate, sucrose, and polysorbate 80, a pharmaceutical composition. Claim 127 A method for treating nail psoriasis in a subject requiring treatment, wherein the method comprises the step of administering a therapeutically effective amount of an antibody comprising a light chain polypeptide having the amino acid sequence of SEQ ID NO. 1 and a heavy chain polypeptide having the amino acid sequence of SEQ ID NO. 2.

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