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NCT07170917PHASE2Recruiting

Brivekimig for the Treatment of Moderate to Severe Hidradenitis Suppurativa

Sanofi

Start Date

11/6/2025

Completion Date

4/27/2028

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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.

Interventions

DRUG

Brivekimig

DRUG

Placebo

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Conditions

Hidradenitis Suppurativa

Locations

Medical Dermatology Specialists - Site Number: 8400019

Phoenix, Arizona 85006

United States

Mayo Clinic in Arizona - Scottsdale- Site Number : 8400014

Scottsdale, Arizona 85259

United States

Northridge Clinical Trials - Northridge- Site Number : 8400005

Northridge, California 91325

United States

FXM Clinical Research - Miami- Site Number : 8400017

Miami, Florida 33175

United States

FXM Clinical Research - Miramar- Site Number : 8400004

Miramar, Florida 33027

United States

Advanced Medical Research - Atlanta- Site Number : 8400011

Atlanta, Georgia 30342

United States

Georgia Skin & Cancer Clinic- Site Number : 8400009

Savannah, Georgia 31419

United States

The Iowa Clinic West Des Moines Campus- Site Number : 8400007

West Des Moines, Iowa 50266

United States

Louisiana Dermatology Associates- Site Number : 8400006

Baton Rouge, Louisiana 70809

United States

Washington University- Site Number : 8400010

St Louis, Missouri 63110

United States

JDR Dermatology Research - Site number: 8400012

Las Vegas, Nevada 89145

United States

Clinical Partners- Site Number : 8400002

Johnston, Rhode Island 02919

United States

AMR Clinical South Strand, South Carolina- Site Number : 8400018

Myrtle Beach, South Carolina 29588

United States

UT Southwestern Medical Center, Department of Dermatology- Site Number : 8400022

Dallas, Texas 75235

United States

Alpine Research Association- Site Number : 8400008

Layton, Utah 84041

United States

Investigational Site Number: 0360001

Liverpool, New South Wales 2170

Australia

Alfred Hospital - Site Number: 0360002

Melbourne, Victoria 3004

Australia

Investigational Site Number : 1240008

Edmonton, Alberta T6H 4J8

Canada

Interior Dermatology Centre - Site Number: 1240003

Kelowna, British Columbia V1W 4V5

Canada

Lima's Excellence in Allergy and Dermatology Research (LEADER) Inc.

Hamilton, Ontario L8L 3C3

Canada

Investigational Site Number : 1240009

Toronto, Ontario M4E 1R7

Canada

Investigational Site Number: 1240005

Québec, Quebec G1W 4R4

Canada

Park Dermatology - Site number: 1240007

Sherwood Park, T8H 0P1

Canada

Investigational Site Number: 1520003

Santiago, Reg Metropolitana de Santiago 7580206

Chile

Investigational Site Number: 1520002

Santiago, Reg Metropolitana de Santiago 7640881

Chile

Investigational Site Number: 1520001

Santiago, Reg Metropolitana de Santiago 8380465

Chile

Investigational Site Number: 1520005

Santiago, Reg Metropolitana de Santiago 8420383

Chile

Investigational Site Number : 1560002

Chengdu, 610041

China

Investigational Site Number : 1560001

Guangzhou, 510018

China

Investigational Site Number : 1560004

Shanghai, 200040

China

Investigational Site Number : 1560005

Ürümqi, 830001

China

Investigational Site Number: 2030002

Ostrava, 702 00

Czechia

Investigational Site Number: 2030003

Ostrava, 708 52

Czechia

Investigational Site Number: 2030001

Prague, 110 00

Czechia

Investigational Site Number: 2030004

Prague, 150 06

Czechia

Investigational Site Number: 2500001

Antony, 92160

France

Investigational Site Number: 2500004

Bezannes, 51430

France

Investigational Site Number : 2500003

Bordeaux, 33000

France

Investigational Site Number : 2500002

Lyon, 69003

France

Investigational Site Number : 2500006

Saint-Priest-en-Jarez, 42270

France

Investigational Site Number: 2500007

Toulouse, 31059

France

Investigational Site Number : 2760002

Bochum, 44791

Germany

Investigational Site Number : 2760008

Bramsche, 49565

Germany

Investigational Site Number : 2760003

Frankfurt, 60590

Germany

Investigational Site Number : 2760005

Kiel, 24105

Germany

Investigational Site Number : 2760004

Mainz, 55131

Germany

Investigational Site Number : 2760001

Münster, 48149

Germany

Investigational Site Number : 2760006

Würzburg, 97080

Germany

Investigational Site Number : 3000002

Athens, 124 62

Greece

Investigational Site Number : 3000001

Athens, 16121

Greece

Investigational Site Number : 3000005

Athens, 16121

Greece

Investigational Site Number : 3000004

Thessaloniki, 564 29

Greece

Site Number: 3480001

Debrecen, Gangwon-do 4032

Hungary

Investigational Site Number: 3480003

Pécs, 7632

Hungary

Investigational Site Number : 3480004

Székesfehérvár, 8000

Hungary

Investigational Site Number : 3760003

Haifa, 3109601

Israel

Investigational Site Number: 3760002

Jerusalem, 9112001

Israel

Investigational Site Number: 3760001

Tel Aviv, 6423906

Israel

Investigational Site Number: 3800002

Milan, Milano 20122

Italy

Investigational Site Number : 3800001

Catania, 95123

Italy

Istituto Dermatologico San Gallicano, IRCCS - Site Number : 3800004

Roma, 00144

Italy

Meiwa Hospital

Nishinomiya, Hyōgo 663-8186

Japan

University of the Ryukyus Hospital - Site Number: 3920002

Nishihara, Okinawa 903-0215

Japan

Nihon University Itabashi Hospital

Tokyo, 173-8610

Japan

Investigational Site Number : 5280002

Groningen, 9713 GR

Netherlands

Investigational Site Number: 6160001

Wroclaw, Lower Silesian Voivodeship 50-566

Poland

Investigational Site Number: 6160003

Lodz, Lódzkie 90-265

Poland

Investigational Site Number: 6160002

Warsaw, Masovian Voivodeship 02-507

Poland

Grupo Dermatologico de Carolina- Site Number : 8400023

Carolina, 00985

Puerto Rico

Investigational Site Number: 7240006

Santiago de Compostela, A Coruña [La Coruña] 15706

Spain

Investigational Site Number: 7240003

Las Palmas de Gran Canaria, Las Palmas 35010

Spain

Investigational Site Number: 7240002

Manises, Valencia 46940

Spain

Investigational Site Number: 7240004

Cadiz, 11009

Spain

Investigational Site Number : 7240007

Granada, 18014

Spain

Investigational Site Number: 7240005

Madrid, 28007

Spain

Investigational Site Number: 7240001

Madrid, 28046

Spain

Investigational Site Number : 7840001

Abu Dhabi, 4167

United Arab Emirates

Investigational Site Number : 8260008

London, England E1 1BB

United Kingdom

Investigational Site Number : 8260006

Leeds, LS9 7TF

United Kingdom