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New drug brivekimig aims to tame painful skin abscesses in hidradenitis suppurativa

NCT ID NCT07170917

Disease control Sponsor: Sanofi Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Aug 21, 2026 · Updated 3 times

Summary

This Phase 2 study tests brivekimig, an injected drug, in 208 people with moderate to severe hidradenitis suppurativa (HS), a chronic skin condition causing painful abscesses and tunnels. Participants receive different doses of brivekimig or a placebo for up to 48 weeks. The main goal is to see if brivekimig can reduce abscess and inflammation counts by at least 75%.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
brivekimig (a drug injected under the skin)
What this could lead to
If it works, this could point toward a new treatment option that reduces painful abscesses and inflammation in people with moderate to severe hidradenitis suppurativa.
What could go wrong
This is an early Phase 2 trial with only 208 participants, so results may not apply to everyone. The drug may not work better than placebo, and side effects are still being studied.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 208 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2025

Expected to finish

Nov 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

hidradenitis suppurativa

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hidradenitis suppurativa

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    79 sites in 19 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

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

    RECRUITING

    Myrtle Beach, South Carolina, 29588, United States

  • Advanced Medical Research - Atlanta- Site Number : 8400011

    RECRUITING

    Atlanta, Georgia, 30342, United States

  • Alfred Hospital - Site Number: 0360002

    RECRUITING

    Melbourne, Victoria, 3004, Australia

  • Alpine Research Association- Site Number : 8400008

    RECRUITING

    Layton, Utah, 84041, United States

  • Clinical Partners- Site Number : 8400002

    RECRUITING

    Johnston, Rhode Island, 02919, United States

  • FXM Clinical Research - Miami- Site Number : 8400017

    RECRUITING

    Miami, Florida, 33175, United States

  • FXM Clinical Research - Miramar- Site Number : 8400004

    RECRUITING

    Miramar, Florida, 33027, United States

  • Georgia Skin & Cancer Clinic- Site Number : 8400009

    RECRUITING

    Savannah, Georgia, 31419, United States

  • Grupo Dermatologico de Carolina- Site Number : 8400023

    RECRUITING

    Carolina, 00985, Puerto Rico

  • Interior Dermatology Centre - Site Number: 1240003

    RECRUITING

    Kelowna, British Columbia, V1W 4V5, Canada

  • Investigational Site Number : 1240008

    RECRUITING

    Edmonton, Alberta, T6H 4J8, Canada

  • Investigational Site Number : 1240009

    RECRUITING

    Toronto, Ontario, M4E 1R7, Canada

  • Investigational Site Number : 1560001

    RECRUITING

    Guangzhou, 510018, China

  • Investigational Site Number : 1560002

    RECRUITING

    Chengdu, 610041, China

  • Investigational Site Number : 1560004

    RECRUITING

    Shanghai, 200040, China

  • Investigational Site Number : 1560005

    RECRUITING

    Ürümqi, 830001, China

  • Investigational Site Number : 2500002

    RECRUITING

    Lyon, 69003, France

  • Investigational Site Number : 2500003

    RECRUITING

    Bordeaux, 33000, France

  • Investigational Site Number : 2500006

    RECRUITING

    Saint-Priest-en-Jarez, 42270, France

  • Investigational Site Number : 2760001

    RECRUITING

    Münster, 48149, Germany

  • Investigational Site Number : 2760002

    RECRUITING

    Bochum, 44791, Germany

  • Investigational Site Number : 2760003

    RECRUITING

    Frankfurt, 60590, Germany

  • Investigational Site Number : 2760004

    RECRUITING

    Mainz, 55131, Germany

  • Investigational Site Number : 2760005

    RECRUITING

    Kiel, 24105, Germany

  • Investigational Site Number : 2760006

    RECRUITING

    Würzburg, 97080, Germany

  • Investigational Site Number : 2760008

    RECRUITING

    Bramsche, 49565, Germany

  • Investigational Site Number : 3000001

    RECRUITING

    Athens, 16121, Greece

  • Investigational Site Number : 3000002

    RECRUITING

    Athens, 124 62, Greece

  • Investigational Site Number : 3000004

    RECRUITING

    Thessaloniki, 564 29, Greece

  • Investigational Site Number : 3000005

    RECRUITING

    Athens, 16121, Greece

  • Investigational Site Number : 3480004

    RECRUITING

    Székesfehérvár, 8000, Hungary

  • Investigational Site Number : 3760003

    RECRUITING

    Haifa, 3109601, Israel

  • Investigational Site Number : 3800001

    RECRUITING

    Catania, 95123, Italy

  • Investigational Site Number : 5280002

    RECRUITING

    Groningen, 9713 GR, Netherlands

  • Investigational Site Number : 7240007

    RECRUITING

    Granada, 18014, Spain

  • Investigational Site Number : 7840001

    RECRUITING

    Abu Dhabi, 4167, United Arab Emirates

  • Investigational Site Number : 8260006

    RECRUITING

    Leeds, LS9 7TF, United Kingdom

  • Investigational Site Number : 8260008

    RECRUITING

    London, England, E1 1BB, United Kingdom

  • Investigational Site Number: 0360001

    RECRUITING

    Liverpool, New South Wales, 2170, Australia

  • Investigational Site Number: 1240005

    RECRUITING

    Québec, Quebec, G1W 4R4, Canada

  • Investigational Site Number: 1520001

    RECRUITING

    Santiago, Reg Metropolitana de Santiago, 8380465, Chile

  • Investigational Site Number: 1520002

    RECRUITING

    Santiago, Reg Metropolitana de Santiago, 7640881, Chile

  • Investigational Site Number: 1520003

    RECRUITING

    Santiago, Reg Metropolitana de Santiago, 7580206, Chile

  • Investigational Site Number: 1520005

    RECRUITING

    Santiago, Reg Metropolitana de Santiago, 8420383, Chile

  • Investigational Site Number: 2030001

    RECRUITING

    Prague, 110 00, Czechia

  • Investigational Site Number: 2030002

    RECRUITING

    Ostrava, 702 00, Czechia

  • Investigational Site Number: 2030003

    RECRUITING

    Ostrava, 708 52, Czechia

  • Investigational Site Number: 2030004

    RECRUITING

    Prague, 150 06, Czechia

  • Investigational Site Number: 2500001

    RECRUITING

    Antony, 92160, France

  • Investigational Site Number: 2500004

    RECRUITING

    Bezannes, 51430, France

  • Investigational Site Number: 2500007

    RECRUITING

    Toulouse, 31059, France

  • Investigational Site Number: 3480003

    RECRUITING

    Pécs, 7632, Hungary

  • Investigational Site Number: 3760001

    RECRUITING

    Tel Aviv, 6423906, Israel

  • Investigational Site Number: 3760002

    RECRUITING

    Jerusalem, 9112001, Israel

  • Investigational Site Number: 3800002

    RECRUITING

    Milan, Milano, 20122, Italy

  • Investigational Site Number: 6160001

    RECRUITING

    Wroclaw, Lower Silesian Voivodeship, 50-566, Poland

  • Investigational Site Number: 6160002

    RECRUITING

    Warsaw, Masovian Voivodeship, 02-507, Poland

  • Investigational Site Number: 6160003

    RECRUITING

    Lodz, Lódzkie, 90-265, Poland

  • Investigational Site Number: 7240001

    RECRUITING

    Madrid, 28046, Spain

  • Investigational Site Number: 7240002

    RECRUITING

    Manises, Valencia, 46940, Spain

  • Investigational Site Number: 7240003

    RECRUITING

    Las Palmas de Gran Canaria, Las Palmas, 35010, Spain

  • Investigational Site Number: 7240004

    RECRUITING

    Cadiz, 11009, Spain

  • Investigational Site Number: 7240005

    RECRUITING

    Madrid, 28007, Spain

  • Investigational Site Number: 7240006

    RECRUITING

    Santiago de Compostela, A Coruña [La Coruña], 15706, Spain

  • Istituto Dermatologico San Gallicano, IRCCS - Site Number : 3800004

    RECRUITING

    Roma, 00144, Italy

    Contact Email: •••••@•••••

  • JDR Dermatology Research - Site number: 8400012

    RECRUITING

    Las Vegas, Nevada, 89145, United States

  • Lima's Excellence in Allergy and Dermatology Research (LEADER) Inc.

    RECRUITING

    Hamilton, Ontario, L8L 3C3, Canada

  • Louisiana Dermatology Associates- Site Number : 8400006

    RECRUITING

    Baton Rouge, Louisiana, 70809, United States

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

    RECRUITING

    Scottsdale, Arizona, 85259, United States

  • Medical Dermatology Specialists - Site Number: 8400019

    RECRUITING

    Phoenix, Arizona, 85006, United States

  • Meiwa Hospital

    RECRUITING

    Nishinomiya, Hyōgo, 663-8186, Japan

  • Nihon University Itabashi Hospital

    RECRUITING

    Tokyo, 173-8610, Japan

  • Northridge Clinical Trials - Northridge- Site Number : 8400005

    RECRUITING

    Northridge, California, 91325, United States

  • Park Dermatology - Site number: 1240007

    RECRUITING

    Sherwood Park, T8H 0P1, Canada

  • Site Number: 3480001

    RECRUITING

    Debrecen, Gangwon-do, 4032, Hungary

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

    RECRUITING

    West Des Moines, Iowa, 50266, United States

  • UT Southwestern Medical Center, Department of Dermatology- Site Number : 8400022

    RECRUITING

    Dallas, Texas, 75235, United States

  • University of the Ryukyus Hospital - Site Number: 3920002

    RECRUITING

    Nishihara, Okinawa, 903-0215, Japan

  • Washington University- Site Number : 8400010

    RECRUITING

    St Louis, Missouri, 63110, United States

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