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Method of treating psoriasis in pediatric subjects with Anti-il12/il23 antibody

A Psoriasis, Pediatrics Technology Applied in the Field of Psoriasis

Pending Publication Date: 2021-12-28
JANSSEN BIOTECH INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although the etiology of psoriasis has not been clearly defined, gene and protein analyzes have shown that interleukin (IL)-12, IL-23, and their downstream molecules are overexpressed in psoriatic lesions, and some may be associated with psoriatic disease. related to the severity of

Method used

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  • Method of treating psoriasis in pediatric subjects with Anti-il12/il23 antibody
  • Method of treating psoriasis in pediatric subjects with Anti-il12/il23 antibody
  • Method of treating psoriasis in pediatric subjects with Anti-il12/il23 antibody

Examples

Experimental program
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Effect test

Embodiment approach

[0196] The invention also provides the following non-limiting embodiments.

[0197] Embodiment 1 is a method of treating psoriasis, preferably moderate to severe chronic plaque psoriasis, in a pediatric patient in need thereof, the method comprising administering to said subject a safe and effective amount of Anti-IL-12 / IL-23p40 antibody.

[0198]Embodiment 1a is the method according to embodiment 1, wherein the antibody comprises a heavy chain variable region and a light chain variable region, the heavy chain variable region comprising: the complementarity determining region of SEQ ID NO: 1 heavy chain 1 (CDRH1) amino acid sequence, the CDRH2 amino acid sequence of SEQ ID NO:2, and the CDRH3 amino acid sequence of SEQ ID NO:3; and the light chain variable region comprises: complementarity determining region light chain 1 (CDRL1 of SEQ ID NO:4 ) amino acid sequence; the CDRL2 amino acid sequence of SEQ ID NO:5; and the CDRL3 amino acid sequence of SEQ ID NO:6.

[0199] Embod...

Embodiment 1

[0295] Example 1: Study of ustekinumab in the treatment of plaque psoriasis in pediatric patients

[0296] The following open-label and multicenter clinical studies were performed in pediatric participants with moderate-to-severe chronic plaque psoriasis aged greater than or equal to 6 years and younger than 12 years: Phase 3 open-label multicenter study with To evaluate the efficacy and safety of ustekinumab induction and maintenance therapy in subjects with moderate-to-severe chronic plaque psoriasis.

[0297] overall rationale

[0298] A study was performed to evaluate the efficacy and safety of subcutaneously (SC) administered ustekinumab in subjects with moderate to severe chronic plaque psoriasis. Participants received weight-based doses of ustekinumab administered subcutaneously (SC) at weeks 0 and 4 and then every 12 weeks (q12w) until week 40.

[0299] Inclusion criteria

[0300] The participant population consisted of boys and girls diagnosed with plaque pso...

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Abstract

Anti-IL-12 / IL-23p40 antibodies, such as ustekinumab, are used in methods and compositions for safe and effective treatment of psoriasis, particularly moderate to severe chronic plaque psoriasis, in pediatric patients. The methods and compositions address a clear unmet medical need in this patient population.

Description

[0001] Reference Sequence Listing Submitted Electronically [0002] This application contains a Sequence Listing submitted electronically via EFS-Web as an ASCII formatted Sequence Listing with the file name "Sequence Listing_688097.0601", a creation date of February 27, 2019, and a size of 14.1 kb. This Sequence Listing submitted via EFS-Web is part of this specification and is hereby incorporated by reference in its entirety. technical field [0003] The present invention relates to methods for providing safe and effective treatment of psoriasis, especially moderate to severe chronic plaque psoriasis, in pediatric patients aged 6 to less than 12 years by administering anti-IL-12 / IL-23 antibodies method. Background technique [0004] Psoriasis is a common chronic immune-mediated skin disease with significant comorbidities such as psoriatic arthritis (PsA), depression, cardiovascular disease, hypertension, obesity, diabetes, metabolic syndrome and Crohn's disease. It is ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07K14/54
CPCA61P29/00C07K14/54A61P37/06C07K14/5434A61K2039/505A61K2039/55A61K2039/54A61K2039/545C07K16/244A61P17/06C07K16/246C07K16/2866C07K2317/92
Inventor M-C·许S·李B·兰达佐K·宋Y·朱
Owner JANSSEN BIOTECH INC