NCT04988308

A Study of Bermekimab for the Treatment of Participants With Moderate to Severe Hidradenitis Suppurativa

A Phase 2a/2b, Multicenter, Randomized, Placebo and Active Comparator-controlled, Double-Blind, Dose-ranging Study to Evaluate the Safety and Efficacy of Bermekimab (JNJ-77474462) for the Treatment of Subjects With Moderate to Severe Hidradenitis Suppurativa

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 151 (actual)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the clinical efficacy of bermekimab in participants with moderate to severe Hidradenitis Suppurativa (HS).

Detailed description

Hidradenitis suppurativa (HS) is a chronic skin disease of unclear etiology that affects 1 percent (%) to 4% of the general population. JNJ-77474462 (bermekimab) is a recombinant human immunoglobulin G1 kappa (IgG1k) monoclonal antibody (mAb) that binds with high affinity and selectivity for human interleukin-1 alpha (IL-1 alpha) and is an effective blocker of IL-1 alpha biological activity. IL-1 alpha is a key mediator of sterile inflammatory responses. Skin is a significant reservoir of preformed IL-1 alpha, and it has been postulated that IL-1 alpha may play a role in the pathophysiology of multiple inflammatory skin disorders, including HS. Part 1 of this study contains 4 study periods: up to 6 weeks screening period (Period 1), 16-week placebo-controlled period (Period 2), 16-week cross over period (Period 3), and 4-week safety follow-up (Period 4). Part 2 of this study also contains 4 study periods: up to 6 weeks screening period (Period 1), 12-week placebo-controlled period (Period 2), 20-week cross over period (Period 3), and 4-week safety follow up (Period 4). Safety will be assessed by adverse events (AEs), serious adverse event (SAEs), physical examinations, vital signs, electrocardiograms, clinical safety laboratory assessments, allergic reaction, injection-site reactions, and tuberculosis evaluations. The total duration of study participation will be up to 42 weeks.

Conditions

• Hidradenitis Suppurativa

Interventions

Type	Name	Description
DRUG	Bermekimab	Bermekimab will be administered subcutaneously.
DRUG	Adalimumab	Adalimumab will be administered subcutaneously.
DRUG	Placebo	Placebo will be administered subcutaneously.

Timeline

• Start date: 2021-10-12
• Primary completion: 2022-10-14
• Completion: 2022-11-23
• First posted: 2021-08-03
• Last updated: 2023-11-13
• Results posted: 2023-11-13

Locations

54 sites across 8 countries: United States, Australia, Canada, Germany, Japan, Netherlands, Poland, Spain

Regulatory

• FDA-regulated drug study