Brivekimig for the Treatment of Moderate to Severe Hidradenitis Suppurativa
Condition(s) studied
Investigational drug(s) / intervention(s)
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
Primary outcome measure(s)
- Percentage of participants achieving Hidradenitis Suppurativa Clinical Response 75 (HiSCR75) — Up to Week 16
Hidradenitis Suppurativa Clinical Response 75 (HiSCR75) is defined as ≥75% reduction from Baseline in the total abscess and inflammatory nodule \[AN\] count, with no increase from Baseline in abscess or draining tunnel count.
Trial sites (79)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 Italy
Other trials for the same condition
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 Italy