Brivekimig for the Treatment of Moderate to Severe Hidradenitis Suppurativa (BRIGHTEN)

June 11, 2026 updated by: Sanofi

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

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 60 weeks for participants not transitioning into the long-term extension (LTE) study and will be up to approximately 52 weeks for participants transitioning into the LTE study.

The randomized treatment duration will be up to approximately 48 weeks.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

208

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Trial Transparency email recommended (Toll free for US & Canada)
  • Phone Number: option 6 800-633-1610
  • Email: Contact-US@sanofi.com

Study Locations

  • Australia
    • New South Wales
      • Liverpool, New South Wales, Australia, 2170
        • Recruiting
        • Investigational Site Number: 0360001
    • Victoria
      • Melbourne, Victoria, Australia, 3004
        • Recruiting
        • Alfred Hospital - Site Number: 0360002
  • Canada
      • Sherwood Park, Canada, T8H 0P1
        • Recruiting
        • Park Dermatology - Site number: 1240007
    • Alberta
      • Edmonton, Alberta, Canada, T6H 4J8
        • Recruiting
        • Investigational Site Number : 1240008
    • British Columbia
      • Kelowna, British Columbia, Canada, V1W 4V5
        • Recruiting
        • Interior Dermatology Centre - Site Number: 1240003
    • Ontario
      • Hamilton, Ontario, Canada, L8L 3C3
        • Recruiting
        • Lima's Excellence in Allergy and Dermatology Research (LEADER) Inc.
      • Toronto, Ontario, Canada, M4E 1R7
        • Recruiting
        • Investigational Site Number : 1240009
    • Quebec
      • Québec, Quebec, Canada, G1W 4R4
        • Recruiting
        • Investigational Site Number: 1240005
  • Chile
    • Reg Metropolitana de Santiago
      • Santiago, Reg Metropolitana de Santiago, Chile, 7580206
        • Recruiting
        • Investigational Site Number: 1520003
      • Santiago, Reg Metropolitana de Santiago, Chile, 7640881
        • Recruiting
        • Investigational Site Number: 1520002
      • Santiago, Reg Metropolitana de Santiago, Chile, 8380465
        • Recruiting
        • Investigational Site Number: 1520001
      • Santiago, Reg Metropolitana de Santiago, Chile, 8420383
        • Recruiting
        • Investigational Site Number: 1520005
  • China
      • Chengdu, China, 610041
        • Recruiting
        • Investigational Site Number : 1560002
      • Guangzhou, China, 510018
        • Recruiting
        • Investigational Site Number : 1560001
      • Shanghai, China, 200040
        • Recruiting
        • Investigational Site Number : 1560004
      • Ürümqi, China, 830001
        • Recruiting
        • Investigational Site Number : 1560005
  • Czechia
      • Ostrava, Czechia, 702 00
        • Recruiting
        • Investigational Site Number: 2030002
      • Ostrava, Czechia, 708 52
        • Recruiting
        • Investigational Site Number: 2030003
      • Prague, Czechia, 150 06
        • Recruiting
        • Investigational Site Number: 2030004
      • Prague, Czechia, 110 00
        • Recruiting
        • Investigational Site Number: 2030001
  • France
      • Antony, France, 92160
        • Recruiting
        • Investigational Site Number: 2500001
      • Bezannes, France, 51430
        • Recruiting
        • Investigational Site Number: 2500004
      • Bordeaux, France, 33000
        • Recruiting
        • Investigational Site Number : 2500003
      • Lyon, France, 69003
        • Recruiting
        • Investigational Site Number : 2500002
      • Saint-Priest-en-Jarez, France, 42270
        • Recruiting
        • Investigational Site Number : 2500006
      • Toulouse, France, 31059
        • Recruiting
        • Investigational Site Number: 2500007
  • Germany
      • Bochum, Germany, 44791
        • Recruiting
        • Investigational Site Number : 2760002
      • Bramsche, Germany, 49565
        • Recruiting
        • Investigational Site Number : 2760008
      • Frankfurt, Germany, 60590
        • Recruiting
        • Investigational Site Number : 2760003
      • Kiel, Germany, 24105
        • Recruiting
        • Investigational Site Number : 2760005
      • Mainz, Germany, 55131
        • Recruiting
        • Investigational Site Number : 2760004
      • Münster, Germany, 48149
        • Recruiting
        • Investigational Site Number : 2760001
      • Würzburg, Germany, 97080
        • Recruiting
        • Investigational Site Number : 2760006
  • Greece
      • Athens, Greece, 16121
        • Recruiting
        • Investigational Site Number : 3000001
      • Athens, Greece, 124 62
        • Recruiting
        • Investigational Site Number : 3000002
      • Athens, Greece, 16121
        • Recruiting
        • Investigational Site Number : 3000005
      • Thessaloniki, Greece, 564 29
        • Recruiting
        • Investigational Site Number : 3000004
  • Hungary
      • Pécs, Hungary, 7632
        • Recruiting
        • Investigational Site Number: 3480003
      • Székesfehérvár, Hungary, 8000
        • Recruiting
        • Investigational Site Number : 3480004
    • Gangwon-do
      • Debrecen, Gangwon-do, Hungary, 4032
        • Recruiting
        • Site Number: 3480001
  • Israel
      • Haifa, Israel, 3109601
        • Recruiting
        • Investigational Site Number : 3760003
      • Jerusalem, Israel, 9112001
        • Recruiting
        • Investigational Site Number: 3760002
      • Tel Aviv, Israel, 6423906
        • Recruiting
        • Investigational Site Number: 3760001
  • Italy
      • Catania, Italy, 95123
        • Recruiting
        • Investigational Site Number : 3800001
      • Roma, Italy, 00144
        • Recruiting
        • Istituto Dermatologico San Gallicano, IRCCS - Site Number : 3800004
        • Contact:
    • Milano
      • Milan, Milano, Italy, 20122
        • Recruiting
        • Investigational Site Number: 3800002
  • Japan
      • Tokyo, Japan, 173-8610
        • Recruiting
        • Nihon University Itabashi Hospital
    • Hyōgo
      • Nishinomiya, Hyōgo, Japan, 663-8186
        • Recruiting
        • Meiwa Hospital
    • Okinawa
      • Nishihara, Okinawa, Japan, 903-0215
        • Recruiting
        • University of the Ryukyus Hospital - Site Number: 3920002
  • Netherlands
      • Groningen, Netherlands, 9713 GR
        • Recruiting
        • Investigational Site Number : 5280002
  • Poland
    • Lower Silesian Voivodeship
      • Wroclaw, Lower Silesian Voivodeship, Poland, 50-566
        • Recruiting
        • Investigational Site Number: 6160001
    • Lódzkie
      • Lodz, Lódzkie, Poland, 90-265
        • Recruiting
        • Investigational Site Number: 6160003
    • Masovian Voivodeship
      • Warsaw, Masovian Voivodeship, Poland, 02-507
        • Recruiting
        • Investigational Site Number: 6160002
  • Puerto Rico
      • Carolina, Puerto Rico, 00985
        • Recruiting
        • Grupo Dermatologico de Carolina- Site Number : 8400023
  • Spain
      • Cadiz, Spain, 11009
        • Recruiting
        • Investigational Site Number: 7240004
      • Granada, Spain, 18014
        • Recruiting
        • Investigational Site Number : 7240007
      • Madrid, Spain, 28046
        • Recruiting
        • Investigational Site Number: 7240001
      • Madrid, Spain, 28007
        • Recruiting
        • Investigational Site Number: 7240005
    • A Coruña [La Coruña]
      • Santiago de Compostela, A Coruña [La Coruña], Spain, 15706
        • Recruiting
        • Investigational Site Number: 7240006
    • Las Palmas
      • Las Palmas de Gran Canaria, Las Palmas, Spain, 35010
        • Recruiting
        • Investigational Site Number: 7240003
    • Valencia
      • Manises, Valencia, Spain, 46940
        • Recruiting
        • Investigational Site Number: 7240002
  • United Arab Emirates
      • Abu Dhabi, United Arab Emirates, 4167
        • Recruiting
        • Investigational Site Number : 7840001
  • United Kingdom
      • Leeds, United Kingdom, LS9 7TF
        • Recruiting
        • Investigational Site Number : 8260006
    • England
      • London, England, United Kingdom, E1 1BB
        • Recruiting
        • Investigational Site Number : 8260008
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • Recruiting
        • Medical Dermatology Specialists - Site Number: 8400019
      • Scottsdale, Arizona, United States, 85259
        • Recruiting
        • Mayo Clinic in Arizona - Scottsdale- Site Number : 8400014
    • California
      • Northridge, California, United States, 91325
        • Recruiting
        • Northridge Clinical Trials - Northridge- Site Number : 8400005
    • Florida
      • Miami, Florida, United States, 33175
        • Recruiting
        • FXM Clinical Research - Miami- Site Number : 8400017
      • Miramar, Florida, United States, 33027
        • Recruiting
        • FXM Clinical Research - Miramar- Site Number : 8400004
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Recruiting
        • Advanced Medical Research - Atlanta- Site Number : 8400011
      • Savannah, Georgia, United States, 31419
        • Recruiting
        • Georgia Skin & Cancer Clinic- Site Number : 8400009
    • Iowa
      • West Des Moines, Iowa, United States, 50266
        • Recruiting
        • The Iowa Clinic West Des Moines Campus- Site Number : 8400007
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70809
        • Recruiting
        • Louisiana Dermatology Associates- Site Number : 8400006
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University- Site Number : 8400010
    • Nevada
      • Las Vegas, Nevada, United States, 89145
        • Recruiting
        • JDR Dermatology Research - Site number: 8400012
    • Rhode Island
      • Johnston, Rhode Island, United States, 02919
        • Recruiting
        • Clinical Partners- Site Number : 8400002
    • South Carolina
      • Myrtle Beach, South Carolina, United States, 29588
        • Recruiting
        • AMR Clinical South Strand, South Carolina- Site Number : 8400018
    • Texas
      • Dallas, Texas, United States, 75235
        • Recruiting
        • UT Southwestern Medical Center, Department of Dermatology- Site Number : 8400022
    • Utah
      • Layton, Utah, United States, 84041
        • Recruiting
        • Alpine Research Association- Site Number : 8400008

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Brivekimig dose regimen A
Participants will receive Brivekimig dose regimen A.
Drug: Brivekimig
  • Pharmaceutical form: Solution for injection in vial
  • Route of administration: Subcutaneous injection
Other Names:
  • SAR442970
Experimental: Brivekimig dose regimen B
Participants will receive Brivekimig dose regimen B.
Drug: Brivekimig
  • Pharmaceutical form: Solution for injection in vial
  • Route of administration: Subcutaneous injection
Other Names:
  • SAR442970
Experimental: Brivekimig dose regimen C
Participants will receive Brivekimig dose regimen C.
Drug: Brivekimig
  • Pharmaceutical form: Solution for injection in vial
  • Route of administration: Subcutaneous injection
Other Names:
  • SAR442970
Placebo Comparator: Placebo
Participants will receive Brivekimig matching placebo.
Drug: Placebo
  • Pharmaceutical form: Solution for injection in vial
  • Route of administration: Subcutaneous injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of participants achieving Hidradenitis Suppurativa Clinical Response 75 (HiSCR75)
Time Frame: Up to Week 16
Hidradenitis Suppurativa Clinical Response 75 (HiSCR75) is defined as ≥75% reduction from Baseline in the total abscess and inflammatory nodule [AN] count, with no increase from Baseline in abscess or draining tunnel count.
Up to Week 16

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of participants achieving Hidradenitis Suppurativa Clinical Response 50 (HiSCR50)
Time Frame: Up to Week 16
Hidradenitis Suppurativa Clinical Response 50 (HiSCR50) is defined as ≥50% reduction from Baseline in the total AN count, with no increase from Baseline in abscess or draining tunnel count.
Up to Week 16
Percentage of participants achieving Hidradenitis Suppurativa Clinical Response 90 (HiSCR90)
Time Frame: Up to Week 16
Hidradenitis Suppurativa Clinical Response 90 (HiSCR90) is defined as ≥90% reduction from Baseline in the total AN count, with no increase from Baseline in abscess or draining tunnel count.
Up to Week 16
Change from Baseline in draining tunnel count at Week 16.
Time Frame: From Baseline to Week 16
From Baseline to Week 16
Percentage of participants achieving response on the Hidradenitis Suppurativa Skin Pain Numeric Rating Scale from the HS Symptom Assessment Questionnaire (HS-SAQ skin pain NRS) at week 8
Time Frame: From Baseline to Week 8
The Hidradenitis Suppurativa Symptom Assessment Questionnaire (HS-SAQ) is a 7-item scale comprising unidimensional numeric rating scale (NRS) items assessing symptoms of HS. The HS-SAQ Skin Pain is based on worst skin pain in a 24-hour recall period (daily assessment is averaged over 7-day period). HS-SAQ skin pain NRS response is defined as ≥3-unit reduction from baseline in the weekly average of daily HS-SAQ Skin Pain NRS.
From Baseline to Week 8
Change from Baseline in Hidradenitis Suppurativa Quality of Life (HiSQOL) total score at Week 16.
Time Frame: From Baseline to Week 16
The Hidradenitis Suppurativa Quality of Life is a 17-item content-validated questionnaire with a 7-day recall period. It is scored by summing items to create a total score (0 to 68) with higher score indicating more severe impact on QoL.
From Baseline to Week 16
Change from Baseline in Dermatology Life Quality Index (DLQI) total score at Week 16.
Time Frame: From Baseline to Week 16
The Dermatology Life Quality Index (DLQI) is a 10-item dermatology specific health related quality of life (HRQoL) instrument. Total score ranges from 0 to 30, with higher scores indicating greater detrimental impact on QoL.
From Baseline to Week 16
Number of participants with treatment-emergent adverse events (TEAE), serious adverse events (SAE) and laboratory anomalies.
Time Frame: Up to End of Study (approximately 60 weeks)
Up to End of Study (approximately 60 weeks)
Serum brivekimig concentration throughout the study.
Time Frame: Up to End of Study (approximately 60 weeks)
Up to End of Study (approximately 60 weeks)
Incidence of treatment-emergent (TE) anti-drug antibody responses.
Time Frame: Up to End of Study (approximately 60 weeks)
Up to End of Study (approximately 60 weeks)
Change from Baseline in International Hidradenitis Suppurativa Severity Score System (IHS4) at Week 16
Time Frame: From Baseline to Week 16
The determination of IHS4 requires counting the inflammatory nodules, abscesses and draining tunnels and multiplying each by a specific coefficient. A high score signifies severe disease.
From Baseline to Week 16

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 6, 2025

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

April 27, 2028

Study Registration Dates

First Submitted

September 5, 2025

First Submitted That Met QC Criteria

September 5, 2025

First Posted (Actual)

September 12, 2025

Study Record Updates

Last Update Posted (Actual)

June 12, 2026

Last Update Submitted That Met QC Criteria

June 11, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DRI19220
  • 2025-522333-61-00 (Registry Identifier: CTIS)
  • U1111-1318-3453 (Other Identifier: WHO ICTRP)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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