Brivekimig for the Treatment of Moderate to Severe Hidradenitis Suppurativa
Sanofi · NCT07170917
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 18+ · All sexes
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Phase 2
- Target enrollment
- 208
- US sites recruiting
- 17
- Study start
- November 6, 2025
- Record last updated
- October 14, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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 164 weeks for participants transitioning into the long-term extension (LTE) period and will be up to approximately 60 weeks for participants not transitioning into the LTE period.
The randomized treatment duration will be up to approximately 152 weeks
Being studied: Brivekimig; Placebo
Conditions: Hidradenitis Suppurativa
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
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 (including myelitis) or neurologic symptoms suggestive of demyelinating disease
- Participants with a history of malignancy or lymphoproliferative disease other than adequately treated or nonmetastatic squamous cell carcinoma of the skin that was excised and completely cured or nonmetastatic basal cell carcinoma of the skin that was excised and completely cured
- History of any other condition which, in the opinion of the Investigator, would put the participant at risk by participation in the protocol
- Active suicidality and therefore significant suicide risk, as judged by the Investigator
- A history of an Adverse Event (AE) attributed to or related to anti-TNF therapy (examples include, but are not limited, to serum sickness or anaphylaxis) for an HS or non-HS indication that would contraindicate readministration of an anti-TNF class therapy
- Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the Investigator, contraindicates participation in the study
- History (within last 2 years prior to Baseline visit) of prescription drug or substance abuse, including alcohol, considered significant by the Investigator
The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Recruiting US locations
Medical Dermatology Specialists- Site Number : 8400019
Phoenix, AZ 85006
Mayo Clinic in Arizona - Scottsdale- Site Number : 8400014
Scottsdale, AZ 85259
Northridge Clinical Trials - Northridge- Site Number : 8400005
Northridge, CA 91325
Beth Israel Deaconess Medical Center - Fort Myers- Site Number : 8400001
Fort Myers, FL 33919
FXM Clinical Research - Miami- Site Number : 8400017
Miami, FL 33175
FXM Clinical Research - Miramar- Site Number : 8400004
Miramar, FL 33027
Advanced Medical Research - Atlanta- Site Number : 8400011
Atlanta, GA 30342
Georgia Skin & Cancer Clinic- Site Number : 8400009
Savannah, GA 31419
The Iowa Clinic West Des Moines Campus- Site Number : 8400007
West Des Moines, IA 50266
Louisiana Dermatology Associates- Site Number : 8400006
Baton Rouge, LA 70809
Washington University- Site Number : 8400010
St Louis, MO 63110
JDR Dermatology Research- Site Number : 8400012
Las Vegas, NV 89145
Icahn School of Medicine at Mount Sinai- Site Number : 8400021
New York, NY 10029
University of North Carolina at Chapel Hill- Site Number : 8400025
Chapel Hill, NC 27514
Clinical Partners- Site Number : 8400002
Johnston, RI 02919
AMR Clinical South Strand, South Carolina- Site Number : 8400018
Myrtle Beach, SC 29588
Ut Southwestern Medical Center, Department Of Dermatology- Site Number : 8400022
Dallas, TX 75235
Study contacts (from the official record)
- Trial Transparency email recommended (Toll free for US & Canada) · 800-633-1610 · contact-us@sanofi.com
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