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Brivekimig for moderate to severe hidradenitis suppurativa

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

Phase 2 Interventional Sanofi · NCT07170917

This trial will test whether brivekimig can reduce symptoms in people with moderate to severe hidradenitis suppurativa.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment208 (estimated)
Ages18 Years and up
SexAll
SponsorSanofi Industry-sponsored
Locations69 sites (Northridge, California and 68 other locations)
Trial IDNCT07170917 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are people with at least six months of moderate to severe HS who have lesions in two or more body areas (one Hurley II or III), an AN count ≥5, a draining tunnel count ≤20, and a history of inadequate response or intolerance to oral antibiotics.

Not a fit: People with mild HS, fewer than five abscesses/inflammatory nodules, more than 20 draining tunnels, or who do not meet the listed anatomical or antibiotic-response criteria are unlikely to qualify or benefit from this trial.

Why it matters

Potential benefit: If successful, brivekimig could reduce inflammatory lesions and improve symptoms and quality of life for people with moderate to severe HS.

How similar studies have performed: Other biologic and targeted therapies have shown benefit in some HS trials, but brivekimig is an investigational agent with limited prior public data.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Northridge, California and 68 other locations

+19 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Hidradenitis Suppurativa
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.