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Treatment of hidradenitis suppurativa

A technology for hidradenitis suppurativa and subjects, applied in the fields of medicine, dermatology and immunology, can solve problems affecting the quality of life of patients

Pending Publication Date: 2019-10-25
JANSSEN BIOTECH INC +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

HS is usually treated with antibiotics and surgery, but frequent relapses seriously affect the patient's quality of life

Method used

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  • Treatment of hidradenitis suppurativa
  • Treatment of hidradenitis suppurativa
  • Treatment of hidradenitis suppurativa

Examples

Experimental program
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Effect test

example 1

[0046] Example 1 - MABpl (True Human Targeting Interleukin-1α TM A double-blind, randomized, placebo-controlled clinical trial of the safety and efficacy of antibody) in HS patients.

[0047] Patients with HS were screened from those currently undergoing follow-up. Inclusion criteria were: written informed consent provided by the patient; age 18 or older; diagnosis of HS; HS with Hurley stage II or III disease or rapidly progressive HS with Hurley stage I; More inflamed nodules; at least one of the following: a) failure of previous treatment with any anti-TNFα regimen; b) recurrence after previous treatment with any anti-TNFα regimen; or c) reluctance to receive subcutaneous adalimumab treatment.

[0048] Exclusion criteria were: history of systemic lupus erythematosus, rheumatoid arthritis, or seronegative inflammatory arthritis; use of any biologic or investigational agent within the past 4 weeks (or 5 half-lives, whichever is longer) Treatment; severe hypersensitivity or ...

example 2

[0076] Key results from an investigator-sponsored randomized phase 2 study evaluating MABpl as a treatment for hidradenitis suppurativa (HS) showed that the study met its primary endpoint, demonstrating significant improvement in HS patients compared to controls after 12 weeks of treatment (Response rates 60% vs. 10%, respectively (p=0.035)).

[0077] A 20-patient, double-blind, placebo-controlled study was designed to evaluate MABpl, a True Human drug targeting interleukin-1α (IL-1α) TM Antibody) safety and efficacy in HS patients ineligible for anti-TNFα therapy. Patients were randomized 1:1 to receive MABpl or placebo every 2 weeks for 12 weeks. Patients in the study underwent an initial efficacy assessment using the Hidradenitis Suppurativa Clinical Response (HiSCR) score at 12 weeks and continued with a follow-up phase to assess time to relapse 12 weeks after cessation of treatment. Outcome measures included assessment of the HiSCR score, a validated method for assessin...

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Abstract

Hidradenitis suppurativa can be treated by administering a pharmaceutical composition that includes a pharmaceutically acceptable carrier and a therapeutically effective amount of an agent that selectively binds interleukin-1 alpha (IL-1 alpha). Disclosed is the use of an antibody targeting and neutralizing interleukin 1 alpha (IL-1 alpha), for the treatment of hidradenitis suppurativa (HS) in a human subject having lesions caused by the disease. More specifically, the use of the monoclonal antibody MABp1 is shown to be effective in reducing the number and / or size of inflammatory lesions in hidradenitis suppurativa.

Description

[0001] Cross References to Related Applications [0002] This application claims priority to US Provisional Patent Application Serial No. 62 / 459,841, entitled "Treatment of Hidradenitis Suppurativa," filed February 16, 2017. [0003] Statement Regarding Federally Funded Research [0004] Not applicable. technical field [0005] The present invention relates generally to the fields of medicine, dermatology and immunology. More specifically, the present invention relates to the use of an antibody (Ab) that specifically binds to interleukin-1α (IL-1α) for the treatment of hidradenitis suppurativa. Background technique [0006] Hidradenitis suppurativa (HS) is a chronic debilitating skin disorder in which nodules that develop in areas rich in apocrine glands gradually swell until they rupture and release pus through the skin. Sinus tracts form and cause scarring. HS is usually treated with antibiotics and surgery, but frequent recurrences seriously affect the quality of life...

Claims

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Application Information

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IPC IPC(8): A61K39/395A61P17/00C07K16/24
CPCA61P17/00C07K16/245A61K2039/505C07K16/1271A61K2039/507C07K2317/21C07K2317/52C07K2317/55
Inventor 斯坦利·A·金埃万盖洛斯·J·伽马雷洛斯-博尔布里斯
Owner JANSSEN BIOTECH INC
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