Actively Recruiting
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
Led by Sanofi · Updated on 2026-05-22
208
Participants Needed
76
Research Sites
38 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the drug brivekimig in a Phase 2b study designed for adults with moderate to severe hidradenitis suppurativa HS, a chronic skin condition. This global, multicenter, randomized, double-blind, placebo-controlled trial aims to assess the safety and effectiveness of different doses of brivekimig in participants with HS lasting at least six months. The study is sponsored by Sanofi and focuses on improving clinical response and quality of life for affected individuals. Participants will be randomly assigned to receive one of three different dose regimens of brivekimig or a matching placebo. The drug is given as a solution for injection under the skin. The treatment period lasts up to approximately 48 weeks, followed by either a maintenance phase or participation in a long-term extension study. The full duration of involvement is up to about 60 weeks for those not entering the extension and approximately 52 weeks for those who do. Throughout the study, participants will undergo regular assessments including clinical evaluations of HS severity, lesion counts, and pain levels using standardized scales. Quality of life will also be measured alongside monitoring for any adverse events or laboratory changes. The main outcome is the percentage of participants achieving a significant clinical response by week 16. Safety and drug levels will be monitored continuously until the end of the study.
CONDITIONS
Brief Title
Brivekimig for the Treatment of Moderate to Severe Hidradenitis Suppurativa
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Diagnosis of moderate to severe hidradenitis suppurativa for at least 6 months prior to baseline
- Presence of HS lesions in at least 2 distinct body areas, with at least one area being Hurley Stage II or III
- Inadequate response, recurrence, intolerance, or contraindication to oral antibiotics for HS
- Biologic-naive or biologic-experienced participants
- Total abscess and inflammatory nodule count of 5 or more at baseline
- Draining tunnel count of 20 or less at baseline
You will not qualify if you...
- Any other active skin disease or condition that may affect HS assessment
- History of recurrent or recent serious infections
- Known significant immunosuppression
- History of solid organ or stem cell transplant
- History of splenectomy
- History of moderate to severe congestive heart failure
- History of demyelinating disease or related neurological symptoms
- History of malignancy or lymphoproliferative disease except certain treated skin cancers
- Any condition posing risk as judged by the investigator
- Active suicidality or significant suicide risk
- History of adverse event related to anti-TNF therapy contraindicating its use
- Sensitivity or allergy to study drugs or their components
- Significant prescription drug or substance abuse within 2 years prior to baseline
Research Team
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