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
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
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
Where Is This Study? (2 UK sites)
Investigational Site Number : 8260008
London E1 1BB, United Kingdom
Investigational Site Number : 8260006
Leeds LS9 7TF, United Kingdom
How to Get in Touch
Trial Transparency email recommended (Toll free for US & Canada)
Sponsor contactCONTACT
