Brivekimig for the Treatment of Moderate to Severe Hidradenitis Suppurativa (NCT07170917) | Clinical Trial Compass
RecruitingPhase 2
Brivekimig for the Treatment of Moderate to Severe Hidradenitis Suppurativa
United States, Australia, Canada208 participantsStarted 2025-11-06
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Participants with a diagnosis of moderate to severe hidradenitis suppurativa (HS) for at least 6 months prior to Baseline
* Participants must have HS lesions present in at least 2 distinct anatomic areas (eg, left and right axilla; or left axilla and left inguinocrural fold), one of which must be Hurley Stage II or Hurley Stage III.
* Participant must have had an inadequate response to a trial of an oral antibiotic for treatment of HS, exhibited recurrence after discontinuation of antibiotics, demonstrated intolerance to antibiotics, or has a contraindication to oral antibiotics for treatment of their HS as assessed by the Investigator through participant interview and review of medical history.
* Participants must be either biologic-naive or biologic-experienced.
* Participant must have a total abscess and inflammatory nodule (AN) count of ≥5 at the Baseline visit.
* Participant must have a draining tunnel count of ≤20 at the Baseline visit.
Exclusion Criteria:
Participants are excluded from the study if any of the following criteria apply:
* Any other active skin disease or condition (eg, bacterial, fungal, or viral infection) that may interfere with assessment of HS
* History of recurrent or recent serious infection
* Known history of significant immunosuppression
* History of solid organ transplant or stem cell transplant
* History of splenectomy
* History of moderate to severe congestive heart failure.
* History of demyelinating disease (includi…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage of participants achieving Hidradenitis Suppurativa Clinical Response 75 (HiSCR75)
Timeframe: Up to Week 16
Trial details
NCT IDNCT07170917
SponsorSanofi
Sponsor typeINDUSTRY
Study typeINTERVENTIONAL
Primary completion2027-08-01
Contact for this trial
Trial Transparency email recommended (Toll free for US & Canada)