NCT07170917

Brivekimig for the Treatment of Moderate to Severe Hidradenitis Suppurativa

A Randomized, Double-blind, Placebo-controlled, Dose-ranging Phase 2 Study of Brivekimig Followed by a Maintenance Period in Participants With Moderate to Severe Hidradenitis Suppurativa

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 208 (estimated)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 2b, global, multicenter, sequential, randomized, double-blind, placebo-controlled, parallel group, dose-ranging study in participants with moderate to severe hidradenitis suppurativa. The purpose of the main study is to assess the efficacy and safety of brivekimig in a dose-ranging study of participants with moderate to severe HS. Study details include: The study duration (per participant) will be up to approximately 60 weeks for participants not transitioning into the long-term extension (LTE) study and will be up to approximately 52 weeks for participants transitioning into the LTE study. The randomized treatment duration will be up to approximately 48 weeks.

Conditions

• Hidradenitis Suppurativa

Interventions

Type	Name	Description
DRUG	Brivekimig	* Pharmaceutical form: Solution for injection in vial * Route of administration: Subcutaneous injection
DRUG	Placebo	* Pharmaceutical form: Solution for injection in vial * Route of administration: Subcutaneous injection

Timeline

• Start date: 2025-11-06
• Primary completion: 2027-08-01
• Completion: 2028-04-27
• First posted: 2025-09-12
• Last updated: 2026-04-08

Locations

69 sites across 18 countries: United States, Australia, Canada, Chile, China, Czechia, France, Germany, Greece, Hungary, Israel, Italy, Japan, Netherlands, Poland, Puerto Rico, Spain, United Kingdom

Regulatory

• FDA-regulated drug study