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Looking for participantsPhase2

Brivekimig for the Treatment of Moderate to Severe Hidradenitis Suppurativa

Sponsor: Sanofi

NCT ID: NCT07170917

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Brivekimig (drug), Placebo (drug)
How long the study runs
Study runs about 48 months (dates as stated)
About the drug or intervention
Brivekimig — drug: * Pharmaceutical form: Solution for injection in vial * Route of administration: Subcutaneous injection · Placebo — drug: * Pharmaceutical form: Solution for injection in vial * Route of administration: Subcutaneous injection
Patient visit burden
Not specified by the sponsor

In plain English

This trial is testing a medicine called brivekimig in people with moderate to severe hidradenitis suppurativa (HS), a long-term skin condition causing painful lumps and abscesses. It is run by Sanofi.

Who can take part

  • Diagnosed with moderate to severe hidradenitis suppurativa (HS) at least 6 months before the start of the study
  • HS sores in at least 2 separate areas of the body, with at least one area at Hurley Stage II or III (a measure of how severe HS is)
  • HS did not get better with oral antibiotics, came back after stopping them, or antibiotics could not be used
  • May or may not have had biologic medicines before
  • At least 5 abscesses or inflamed lumps at the start of the study
  • 20 or fewer draining tunnels (tracks leaking fluid) at the start of the study

Who may not be able to

  • Another skin condition or active infection that could affect HS checks
  • Past or recent serious infections
  • A weakened immune system
  • Organ or stem cell transplant, or removal of the spleen
  • Moderate to severe heart failure
  • Nerve conditions such as demyelinating disease, or symptoms suggesting one
  • Most types of cancer, except some fully treated skin cancers
  • Any other condition the doctor thinks makes taking part unsafe
  • Active suicidal thoughts, as judged by the doctor
  • A past bad reaction to anti-TNF medicines that means they cannot be used again
  • Allergy or sensitivity to the study medicines
  • Drug, alcohol or substance misuse in the past 2 years

What taking part involves

  • • Not stated — ask the trial team

Time commitment: Not stated — ask the trial team

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
208
Started
2025-11-06
Last checked
2026-08

Plain English Summary

What is this study?

  • • Testing a new treatment for hidradenitis suppurativa
  • • Phase2 - 208 participants
  • • 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

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with hidradenitis suppurativa

Where?

  • • London - Investigational Site Number : 8260008
  • • Leeds - Investigational Site Number : 8260006

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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

Hidradenitis Suppurativa

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
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Still need:

  • • Tell us your age for better matching
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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

Treatment history

Treatments you must have had:

  • ✓ HS lesions present in at least 2 distinct anatomic areas (eg, left and right axilla
  • ✓ a total abscess and inflammatory nodule (AN) count of ≥5 at the Baseline visit
  • ✓ a draining tunnel count of ≤20 at the Baseline visit

What the study is looking for

  • ✓Participants with a diagnosis of moderate to severe hidradenitis suppurativa (HS) for at least 6 months prior to...
  • ✓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.

Who cannot take part

  • ✗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...
  • ✗History of recurrent or recent serious infection
  • ✗Known history of significant immunosuppression
  • ✗History of solid organ transplant or stem cell transplant
See the 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.

Where Is This Study? (2 UK sites)

Investigational Site Number : 8260008

London E1 1BB, United Kingdom

Recruiting

Investigational Site Number : 8260006

Leeds LS9 7TF, United Kingdom

Recruiting

How to Get in Touch

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

Sponsor contact

CONTACT

800-633-1610 contact-us@sanofi.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-08