Skip to content
Bored Studies
RecruitingPhase 2

Brivekimig for the Treatment of Moderate to Severe Hidradenitis Suppurativa

Sanofi · NCT07170917

View Study & Apply (opens in a new tab)

Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 2
Target enrollment
208
US sites recruiting
17
Study start
November 6, 2025
Record last updated
October 14, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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

Being studied: Brivekimig; Placebo

Conditions: Hidradenitis Suppurativa

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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.

Recruiting US locations

  • Medical Dermatology Specialists- Site Number : 8400019

    Phoenix, AZ 85006

  • Mayo Clinic in Arizona - Scottsdale- Site Number : 8400014

    Scottsdale, AZ 85259

  • Northridge Clinical Trials - Northridge- Site Number : 8400005

    Northridge, CA 91325

  • Beth Israel Deaconess Medical Center - Fort Myers- Site Number : 8400001

    Fort Myers, FL 33919

  • FXM Clinical Research - Miami- Site Number : 8400017

    Miami, FL 33175

  • FXM Clinical Research - Miramar- Site Number : 8400004

    Miramar, FL 33027

  • Advanced Medical Research - Atlanta- Site Number : 8400011

    Atlanta, GA 30342

  • Georgia Skin & Cancer Clinic- Site Number : 8400009

    Savannah, GA 31419

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

    West Des Moines, IA 50266

  • Louisiana Dermatology Associates- Site Number : 8400006

    Baton Rouge, LA 70809

  • Washington University- Site Number : 8400010

    St Louis, MO 63110

  • JDR Dermatology Research- Site Number : 8400012

    Las Vegas, NV 89145

  • Icahn School of Medicine at Mount Sinai- Site Number : 8400021

    New York, NY 10029

  • University of North Carolina at Chapel Hill- Site Number : 8400025

    Chapel Hill, NC 27514

  • Clinical Partners- Site Number : 8400002

    Johnston, RI 02919

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

    Myrtle Beach, SC 29588

  • Ut Southwestern Medical Center, Department Of Dermatology- Site Number : 8400022

    Dallas, TX 75235

Study contacts (from the official record)

  • Trial Transparency email recommended (Toll free for US & Canada) · 800-633-1610 · contact-us@sanofi.com
All dermatology studies in Arizona →
Brivekimig for the Treatment of Moderate to Severe Hidradenitis… (NCT07170917) | Bored Studies