Brivekimig for the Treatment of Moderate to Severe Hidradenitis Suppurativa
NCT ID: NCT07170917
Last Updated: 2026-02-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
188 participants
INTERVENTIONAL
2025-11-06
2028-04-27
Brief Summary
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The purpose of this 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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Brivekimig dose regimen A
Participants will receive Brivekimig dose regimen A.
Brivekimig
* Pharmaceutical form: Solution for injection in vial
* Route of administration: Subcutaneous injection
Brivekimig dose regimen B
Participants will receive Brivekimig dose regimen B.
Brivekimig
* Pharmaceutical form: Solution for injection in vial
* Route of administration: Subcutaneous injection
Brivekimig dose regimen C
Participants will receive Brivekimig dose regimen C.
Brivekimig
* Pharmaceutical form: Solution for injection in vial
* Route of administration: Subcutaneous injection
Placebo
Participants will receive Brivekimig matching placebo.
Placebo
* Pharmaceutical form: Solution for injection in vial
* Route of administration: Subcutaneous injection
Interventions
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Brivekimig
* Pharmaceutical form: Solution for injection in vial
* Route of administration: Subcutaneous injection
Placebo
* Pharmaceutical form: Solution for injection in vial
* Route of administration: Subcutaneous injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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Locations
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Northridge Clinical Trials - Northridge- Site Number : 8400005
Northridge, California, United States
FXM Clinical Research - Miami- Site Number : 8400017
Miami, Florida, United States
FXM Clinical Research Miramar, LLC - Site Number: 8400004
Miramar, Florida, United States
Advanced Medical Research - Atlanta- Site Number : 8400011
Atlanta, Georgia, United States
Georgia Skin & Cancer Clinic- Site Number : 8400009
Savannah, Georgia, United States
Louisiana Dermatology Associates- Site Number : 8400006
Baton Rouge, Louisiana, United States
Clinical Partners- Site Number : 8400002
Johnston, Rhode Island, United States
Alliance for Multispecialty Research - Myrtle Beach- Site Number : 8400018
Myrtle Beach, South Carolina, United States
Alpine Research Association- Site Number : 8400008
Layton, Utah, United States
Alfred Hospital - Site Number: 0360002
Melbourne, Victoria, Australia
Interior Dermatology Centre - Site Number: 1240003
Kelowna, British Columbia, Canada
Lima's Excellence in Allergy and Dermatology Research (LEADER) Inc.
Hamilton, Ontario, Canada
Investigational Site Number : 1240009
Toronto, Ontario, Canada
Investigational Site Number: 1520003
Santiago, Reg Metropolitana de Santiago, Chile
Investigational Site Number: 1520002
Santiago, Reg Metropolitana de Santiago, Chile
Investigational Site Number: 1520001
Santiago, Reg Metropolitana de Santiago, Chile
Investigational Site Number: 1520005
Santiago, Reg Metropolitana de Santiago, Chile
Investigational Site Number : 1560002
Chengdu, , China
Investigational Site Number : 1560001
Guangzhou, , China
Investigational Site Number: 2030002
Ostrava, , Czechia
Investigational Site Number: 2030003
Ostrava, , Czechia
Investigational Site Number: 2030001
Prague, , Czechia
Investigational Site Number: 2030004
Prague, , Czechia
Investigational Site Number : 2760008
Bramsche, , Germany
Investigational Site Number : 3480004
Székesfehérvár, , Hungary
Investigational Site Number: 3760002
Jerusalem, , Israel
Investigational Site Number: 3760001
Tel Aviv, , Israel
Meiwa Hospital
Nishinomiya, Hyōgo, Japan
University of the Ryukyus Hospital - Site Number: 3920002
Nishihara, Okinawa, Japan
Nihon University Itabashi Hospital
Tokyo, , Japan
Investigational Site Number: 6160003
Lodz, Lódzkie, Poland
Investigational Site Number: 7240003
Las Palmas de Gran Canaria, Las Palmas, Spain
Investigational Site Number: 7240002
Manises, Valencia, Spain
Investigational Site Number : 7240007
Granada, , Spain
Investigational Site Number: 7240001
Madrid, , Spain
Investigational Site Number : 8260008
London, England, United Kingdom
Investigational Site Number : 8260006
Leeds, , United Kingdom
Countries
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Central Contacts
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Trial Transparency email recommended (Toll free for US & Canada)
Role: CONTACT
Related Links
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DRI19220 Plain Language Results Summary
Other Identifiers
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2025-522333-61-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
U1111-1318-3453
Identifier Type: OTHER
Identifier Source: secondary_id
DRI19220
Identifier Type: -
Identifier Source: org_study_id
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