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Clinical Trials in China / NCT07170917
Recruiting Phase 2

Brivekimig for the Treatment of Moderate to Severe Hidradenitis Suppurativa

NCT07170917 · tracked via the Priya Life Science China tracker
Sponsor
Sanofi
Phase
Phase 2
Started
2025-11-06
Last updated
2026-08-20

Condition(s) studied

Hidradenitis Suppurativa

Investigational drug(s) / intervention(s)

BrivekimigPlacebo

Brivekimig: * Pharmaceutical form: Solution for injection in vial * Route of administration: Subcutaneous injection

Placebo: * Pharmaceutical form: Solution for injection in vial * Route of administration: Subcutaneous injection

Study 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 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

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (79)

FacilityCityRegionStatus
Medical Dermatology Specialists - Site Number: 8400019 Phoenix Arizona Recruiting
Mayo Clinic in Arizona - Scottsdale- Site Number : 8400014 Scottsdale Arizona Recruiting
Northridge Clinical Trials - Northridge- Site Number : 8400005 Northridge California Recruiting
FXM Clinical Research - Miami- Site Number : 8400017 Miami Florida Recruiting
FXM Clinical Research - Miramar- Site Number : 8400004 Miramar Florida Recruiting
Advanced Medical Research - Atlanta- Site Number : 8400011 Atlanta Georgia Recruiting
Georgia Skin & Cancer Clinic- Site Number : 8400009 Savannah Georgia Recruiting
The Iowa Clinic West Des Moines Campus- Site Number : 8400007 West Des Moines Iowa Recruiting
Louisiana Dermatology Associates- Site Number : 8400006 Baton Rouge Louisiana Recruiting
Washington University- Site Number : 8400010 St Louis Missouri Recruiting
JDR Dermatology Research - Site number: 8400012 Las Vegas Nevada Recruiting
Clinical Partners- Site Number : 8400002 Johnston Rhode Island Recruiting
AMR Clinical South Strand, South Carolina- Site Number : 8400018 Myrtle Beach South Carolina Recruiting
UT Southwestern Medical Center, Department of Dermatology- Site Number : 8400022 Dallas Texas Recruiting
Alpine Research Association- Site Number : 8400008 Layton Utah Recruiting
Investigational Site Number: 0360001 Liverpool New South Wales Recruiting
Alfred Hospital - Site Number: 0360002 Melbourne Victoria Recruiting
Investigational Site Number : 1240008 Edmonton Alberta Recruiting
Interior Dermatology Centre - Site Number: 1240003 Kelowna British Columbia Recruiting
Lima's Excellence in Allergy and Dermatology Research (LEADER) Inc. Hamilton Ontario Recruiting
Investigational Site Number : 1240009 Toronto Ontario Recruiting
Investigational Site Number: 1240005 Québec Quebec Recruiting
Park Dermatology - Site number: 1240007 Sherwood Park Canada Recruiting
Investigational Site Number: 1520003 Santiago Reg Metropolitana de Santiago Recruiting
Investigational Site Number: 1520002 Santiago Reg Metropolitana de Santiago Recruiting
Investigational Site Number: 1520001 Santiago Reg Metropolitana de Santiago Recruiting
Investigational Site Number: 1520005 Santiago Reg Metropolitana de Santiago Recruiting
Investigational Site Number : 1560002 Chengdu China Recruiting
Investigational Site Number : 1560001 Guangzhou China Recruiting
Investigational Site Number : 1560004 Shanghai China Recruiting
Investigational Site Number : 1560005 Ürümqi China Recruiting
Investigational Site Number: 2030002 Ostrava Czechia Recruiting
Investigational Site Number: 2030003 Ostrava Czechia Recruiting
Investigational Site Number: 2030001 Prague Czechia Recruiting
Investigational Site Number: 2030004 Prague Czechia Recruiting
Investigational Site Number: 2500001 Antony France Recruiting
Investigational Site Number: 2500004 Bezannes France Recruiting
Investigational Site Number : 2500003 Bordeaux France Recruiting
Investigational Site Number : 2500002 Lyon France Recruiting
Investigational Site Number : 2500006 Saint-Priest-en-Jarez France Recruiting

+ 39 more sites — see the full list on the official registry below.

More Sanofi trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07170917 on ClinicalTrials.gov ↗ ← All trials in China