Recruiting
Phase 2

Brivekimig

Sponsor:

Sanofi

Code:

NCT07170917

Conditions

Hidradenitis Suppurativa

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Brivekimig

Placebo

Study Details

Brief 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

Conditions

Hidradenitis Suppurativa

Study ID

NCT07170917

Start date

Nov 6, 2025

Status verified date

Aug, 2026

Completion date

Nov 23, 2029

Anticipated

Primary completion date

Feb 9, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

208 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Brivekimig dose regimen A

Participants will receive Brivekimig dose regimen A.

experimental: Brivekimig dose regimen B

Participants will receive Brivekimig dose regimen B.

experimental: Brivekimig dose regimen C

Participants will receive Brivekimig dose regimen C.

placebo comparator: Placebo

Participants will receive Brivekimig matching placebo.

Interventions

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

Primary outcome measure

  • Percentage of participants achieving Hidradenitis Suppurativa Clinical Response 75 (HiSCR75) [ Time Frame: Up to Week 16 ]

Central Contacts and Locations

Central contacts

Trial Transparency email recommended (Toll free for US & Canada)

800-633-1610contact-us@sanofi.com

Locations

Medical Dermatology Specialists - Site Number: 8400019

Recruiting

Phoenix, Arizona, United States, 85006

Mayo Clinic in Arizona - Scottsdale- Site Number : 8400014

Recruiting

Scottsdale, Arizona, United States, 85259

Northridge Clinical Trials - Northridge- Site Number : 8400005

Recruiting

Northridge, California, United States, 91325

FXM Clinical Research - Miami- Site Number : 8400017

Recruiting

Miami, Florida, United States, 33175

FXM Clinical Research - Miramar- Site Number : 8400004

Recruiting

Miramar, Florida, United States, 33027

Advanced Medical Research - Atlanta- Site Number : 8400011

Recruiting

Atlanta, Georgia, United States, 30342

Georgia Skin & Cancer Clinic- Site Number : 8400009

Recruiting

Savannah, Georgia, United States, 31419

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

Recruiting

West Des Moines, Iowa, United States, 50266

Louisiana Dermatology Associates- Site Number : 8400006

Recruiting

Baton Rouge, Louisiana, United States, 70809

Washington University- Site Number : 8400010

Recruiting

St Louis, Missouri, United States, 63110

JDR Dermatology Research - Site number: 8400012

Recruiting

Las Vegas, Nevada, United States, 89145

Clinical Partners- Site Number : 8400002

Recruiting

Johnston, Rhode Island, United States, 02919

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

Recruiting

Myrtle Beach, South Carolina, United States, 29588

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

Recruiting

Dallas, Texas, United States, 75235

Alpine Research Association- Site Number : 8400008

Recruiting

Layton, Utah, United States, 84041

Investigational Site Number : 1240008

Recruiting

Edmonton, Alberta, Canada, T6H 4J8

Interior Dermatology Centre - Site Number: 1240003

Recruiting

Kelowna, British Columbia, Canada, V1W 4V5

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

Recruiting

Hamilton, Ontario, Canada, L8L 3C3

Investigational Site Number : 1240009

Recruiting

Toronto, Ontario, Canada, M4E 1R7

Investigational Site Number: 1240005

Recruiting

Québec, Quebec, Canada, G1W 4R4

Park Dermatology - Site number: 1240007

Recruiting

Sherwood Park, Canada, T8H 0P1

More Information

Sponsor

Sanofi

Last update posted

Aug 20, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Sanofi on 2026-08-20.