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RECRUITING

NCT07170917

PHASE2

Brivekimig for the Treatment of Moderate to Severe Hidradenitis Suppurativa

Sponsor: Sanofi

View on ClinicalTrials.gov

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.

Official title: A Randomized, Double-blind, Placebo-controlled, Dose-ranging Phase 2 Study of Brivekimig Followed by a Maintenance Period in Participants With Moderate to Severe Hidradenitis Suppurativa

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

208

Start Date

2025-11-06

Completion Date

2028-04-27

Last Updated

2026-04-08

Healthy Volunteers

Conditions

Hidradenitis Suppurativa

Interventions

DRUG

Brivekimig

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

DRUG

Placebo

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

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.

Locations (69)

Northridge Clinical Trials - Northridge- Site Number : 8400005

Northridge, California, United States

FXM Clinical Research - Miami- Site Number : 8400017

Miami, Florida, United States

FXM Clinical Research Miramar, LLC - Site Number: 8400004

Miramar, Florida, United States

Advanced Medical Research - Atlanta- Site Number : 8400011

Atlanta, Georgia, United States

Georgia Skin & Cancer Clinic- Site Number : 8400009

Savannah, Georgia, United States

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

West Des Moines, Iowa, United States

Louisiana Dermatology Associates- Site Number : 8400006

Baton Rouge, Louisiana, United States

JDR Dermatology Research - Site number: 8400012

Las Vegas, Nevada, United States

Clinical Partners- Site Number : 8400002

Johnston, Rhode Island, United States

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

Myrtle Beach, South Carolina, United States

Alpine Research Association- Site Number : 8400008

Layton, Utah, United States

Investigational Site Number: 0360001

Liverpool, New South Wales, Australia

Alfred Hospital - Site Number: 0360002

Melbourne, Victoria, Australia

Interior Dermatology Centre - Site Number: 1240003

Kelowna, British Columbia, Canada

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

Hamilton, Ontario, Canada

Investigational Site Number : 1240009

Toronto, Ontario, Canada

Investigational Site Number: 1240005

Québec, Quebec, Canada

Park Dermatology - Site number: 1240007

Sherwood Park, Canada

Investigational Site Number: 1520003

Santiago, Reg Metropolitana de Santiago, Chile

Investigational Site Number: 1520002

Santiago, Reg Metropolitana de Santiago, Chile

Investigational Site Number: 1520001

Santiago, Reg Metropolitana de Santiago, Chile

Investigational Site Number: 1520005

Santiago, Reg Metropolitana de Santiago, Chile

Investigational Site Number : 1560002

Chengdu, China

Investigational Site Number : 1560001

Guangzhou, China

Investigational Site Number : 1560005

Ürümqi, China

Investigational Site Number: 2030002

Ostrava, Czechia

Investigational Site Number: 2030003

Ostrava, Czechia

Investigational Site Number: 2030001

Prague, Czechia

Investigational Site Number: 2030004

Prague, Czechia

Investigational Site Number: 2500001

Antony, France

Investigational Site Number: 2500004

Bezannes, France

Investigational Site Number : 2500003

Bordeaux, France

Investigational Site Number : 2500002

Lyon, France

Investigational Site Number : 2500006

Saint-Priest-en-Jarez, France

Investigational Site Number: 2500007

Toulouse, France

Investigational Site Number : 2760002

Bochum, Germany

Investigational Site Number : 2760008

Bramsche, Germany

Investigational Site Number : 2760003

Frankfurt, Germany

Investigational Site Number : 2760005

Kiel, Germany

Investigational Site Number : 2760004

Mainz, Germany

Investigational Site Number : 2760001

Münster, Germany

Investigational Site Number : 2760006

Würzburg, Germany

Investigational Site Number : 3000001

Athens, Greece

Investigational Site Number : 3000005

Athens, Greece

Investigational Site Number : 3000004

Thessaloniki, Greece

Site Number: 3480001

Debrecen, Gangwon-do, Hungary

Investigational Site Number: 3480003

Pécs, Hungary

Investigational Site Number : 3480004

Székesfehérvár, Hungary

Investigational Site Number: 3760002

Jerusalem, Israel

Investigational Site Number: 3760001

Tel Aviv, Israel

Investigational Site Number: 3800002

Milan, Milano, Italy

Istituto Dermatologico San Gallicano, IRCCS - Site Number : 3800004

Roma, Italy

Meiwa Hospital

Nishinomiya, Hyōgo, Japan

University of the Ryukyus Hospital - Site Number: 3920002

Nishihara, Okinawa, Japan

Nihon University Itabashi Hospital

Tokyo, Japan

Investigational Site Number : 5280002

Groningen, Netherlands

Investigational Site Number: 6160001

Wroclaw, Lower Silesian Voivodeship, Poland

Investigational Site Number: 6160003

Lodz, Lódzkie, Poland

Investigational Site Number: 6160002

Warsaw, Masovian Voivodeship, Poland

Grupo Dermatologico de Carolina- Site Number : 8400023

Carolina, Puerto Rico

Investigational Site Number: 7240006

Santiago de Compostela, A Coruña [La Coruña], Spain

Investigational Site Number: 7240003

Las Palmas de Gran Canaria, Las Palmas, Spain

Investigational Site Number: 7240002

Manises, Valencia, Spain

Investigational Site Number: 7240004

Cadiz, Spain

Investigational Site Number : 7240007

Granada, Spain

Investigational Site Number: 7240005

Madrid, Spain

Investigational Site Number: 7240001

Madrid, Spain

Investigational Site Number : 8260008

London, England, United Kingdom

Investigational Site Number : 8260006

Leeds, United Kingdom

Clinical Research Directory

Brivekimig for the Treatment of Moderate to Severe Hidradenitis Suppurativa

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (69)