DRI19220-BRIGHTEN
Research type
Research Study
Full title
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
IRAS ID
1012809
Contact name
Patrick Maury
Contact email
Sponsor organisation
Sanofi-Aventis Recherche & Développement
Eudract number
2025-522333-61
Research summary
This Phase 2 clinical trial will evaluate the safety and effectiveness of brivekimig, an investigational drug for treating moderate to severe hidradenitis suppurativa (HS). HS is a chronic, painful inflammatory skin condition that causes abscesses and scarring in areas with sweat glands. The study will include approximately 188 adult participants with diagnosed moderate to severe HS for at least 6 months and have had inadequate response to a trial of an oral antibiotic, intolerance to antibiotics or exhibited recurrence after discontinuation of antibiotics for treatment of their HS. Participants will be randomly assigned to receive one of four treatments:
Brivekimig 150 mg every 2 weeks
Brivekimig 300 mg every 4 weeks
Brivekimig 50 mg every 2 weeks
Placebo (inactive treatment)
The study has two main treatment periods:
Initial 16-week period where participants receive their assigned treatment
Maintenance 32-week period where participants either:
Continue their original treatment (150 mg or 300 mg groups)
Switch to one of the higher doses (50 mg and placebo groups)
The main goal is to evaluate if brivekimig can reduce HS symptoms after 16 weeks of treatment, specifically looking at:
Reduction in inflammatory nodules and abscesses, Improvement in pain and quality of life, Safety and side effects, Participants will have regular study visits to receive study treatment injections, have their HS symptoms evaluated, complete questionnaires about symptoms and quality of life, have blood tests and safety monitoring, the study will be conducted at multiple research centers globally. Participants who complete the study and show improvement may have the opportunity to continue receiving brivekimig in a long-term extension study. This research will help determine if brivekimig could be an effective new treatment option for people with moderate to severe HS who have not had adequate relief with other therapies.REC name
London - London Bridge Research Ethics Committee
REC reference
25/LO/0599
Date of REC Opinion
6 Oct 2025
REC opinion
Further Information Favourable Opinion