Brivekimig for moderate to severe hidradenitis suppurativa

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 2b, global, multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose-ranging trial testing brivekimig in participants with moderate to severe hidradenitis suppurativa. Participants must have had HS for at least six months, lesions in two or more distinct anatomic areas with at least one area Hurley Stage II or III, an abscess and inflammatory nodule (AN) count of ≥5, and a draining tunnel count of ≤20. The randomized treatment period is up to approximately 48 weeks, and total participation may last up to about 52–60 weeks depending on transition into a long-term extension. Both biologic-naive and biologic-experienced participants are eligible, and a history of inadequate response or intolerance to oral antibiotics is required.

Why it matters

Who can join: the full rules

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.

Where it's running

• Medical Dermatology Specialists- Site Number : 8400019
  Phoenix, Arizona, United States Recruiting
• Mayo Clinic in Arizona - Scottsdale- Site Number : 8400014
  Scottsdale, Arizona, United States Recruiting
• Northridge Clinical Trials - Northridge- Site Number : 8400005
  Northridge, California, United States Recruiting
• Beth Israel Deaconess Medical Center - Fort Myers- Site Number : 8400001
  Fort Myers, Florida, United States Recruiting
• FXM Clinical Research - Miami- Site Number : 8400017
  Miami, Florida, United States Recruiting
• FXM Clinical Research - Miramar- Site Number : 8400004
  Miramar, Florida, United States Recruiting

+35 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Trial Transparency email recommended (Toll free for US & Canada)
• Email: contact-us@sanofi.com
• Phone: 800-633-1610

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• BTK inhibitor remibrutinib in hidradenitis suppurativa shows how it works in adults

  This phase 1 trial tests whether remibrutinib can safely affect HS in adults with moderate to severe disease.

  Recruiting at 2 sites Phase 1 Novartis · San Diego, California and 1 other locations · NCT07855276

• Olatorepatide vs placebo for adults with moderate-to-severe hidradenitis suppurativa who are overweight

  This study tests whether olatorepatide can help people with hidradenitis suppurativa who are overweight or obese.

  Recruiting Phase 2 Regeneron Pharmaceuticals · The Bronx, New York · NCT07830329

• Remibrutinib extension study for adults with moderate to severe hidradenitis suppurativa

  This extension study tests whether continuing remibrutinib is safe and helps skin symptoms in adults who completed prior HS trials.

  Recruiting at 61 sites Phase 3 Novartis · Birmingham, Alabama and 60 other locations · NCT07665437

• LAD328 in adults with hidradenitis suppurativa

  This study tests whether LAD328 works better than placebo for adults with moderate-to-severe hidradenitis suppurativa.

  Recruiting Phase 2 Almirall, S.A. · Warsaw, Masovian Voivodeship · NCT07547813

• Long-term real-world tracking of secukinumab treatment for moderate to severe hidradenitis suppurativa in Italy

  This project will see how secukinumab works and is used in adults with moderate to severe hidradenitis suppurativa in Italy.

  Recruiting at 16 sites Novartis · Ancona, AN and 15 other locations · NCT07543419

• Secukinumab outcomes in Canadians with hidradenitis suppurativa

  It will see how well secukinumab works and how safe it is for adults in Canada with moderate-to-severe hidradenitis suppurativa who were newly prescribed it in routine care.

  Recruiting at 15 sites Novartis · Calgary, Alberta and 14 other locations · NCT07282015

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.