Phase 2 Study of Brivekimig Injections for Moderate to Severe Hidradenitis Suppurativa with Dose Ranging and Maintenance Period

What this Trial Is About

Researchers are studying Brivekimig, a medication given as a subcutaneous injection, in people with moderate to severe hidradenitis suppurativa HS. This Phase 2b, global, randomized, double-blind, placebo-controlled trial aims to evaluate the safety and effectiveness of different doses of Brivekimig for treating HS. Participants have had HS for at least six months and have moderate to severe symptoms affecting multiple areas of the body. Participants will be randomly assigned to receive one of three dosing regimens of Brivekimig or a matching placebo. The study drug is given through injections and the treatment period lasts up to approximately 48 weeks. Some participants may continue into a longer-term extension study, making total participation last up to about 52 to 60 weeks. The trial includes a maintenance period following the initial treatment. During the study, participants will have regular visits to assess their skin condition, pain levels, quality of life, and any side effects. Researchers will measure improvements using tools like the Hidradenitis Suppurativa Clinical Response HiSCR at various points up to Week 16. Safety will be monitored throughout the study, including tracking adverse events and laboratory tests. Participants drug levels and immune responses will also be checked. Overall, the trial will last up to about 60 weeks depending on extension participation.

Brivekimig for the Treatment of Moderate to Severe Hidradenitis Suppurativa