Hidradenitis Suppurativa Clinical Trials

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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

Status: Recruiting
Location: See all (65) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
California
Northridge Clinical Trials - Northridge- Site Number : 8400005
RECRUITING
Northridge
Florida
FXM Clinical Research - Miami- Site Number : 8400017
RECRUITING
Miami
FXM Clinical Research Miramar, LLC - Site Number: 8400004
RECRUITING
Miramar
Georgia
Advanced Medical Research - Atlanta- Site Number : 8400011
RECRUITING
Atlanta
Georgia Skin & Cancer Clinic- Site Number : 8400009
RECRUITING
Savannah
Iowa
The Iowa Clinic West Des Moines Campus- Site Number : 8400007
RECRUITING
West Des Moines
Louisiana
Louisiana Dermatology Associates- Site Number : 8400006
RECRUITING
Baton Rouge
Nevada
JDR Dermatology Research - Site number: 8400012
RECRUITING
Las Vegas
Rhode Island
Clinical Partners- Site Number : 8400002
RECRUITING
Johnston
South Carolina
AMR Clinical South Strand, South Carolina- Site Number : 8400018
RECRUITING
Myrtle Beach
Utah
Alpine Research Association- Site Number : 8400008
RECRUITING
Layton
Other Locations
Australia
Investigational Site Number: 0360001
RECRUITING
Liverpool
Alfred Hospital - Site Number: 0360002
RECRUITING
Melbourne
Canada
Lima's Excellence in Allergy and Dermatology Research (LEADER) Inc.
RECRUITING
Hamilton
Interior Dermatology Centre - Site Number: 1240003
RECRUITING
Kelowna
Investigational Site Number: 1240005
RECRUITING
Québec
Park Dermatology - Site number: 1240007
RECRUITING
Sherwood Park
Investigational Site Number : 1240009
RECRUITING
Toronto
Chile
Investigational Site Number: 1520001
RECRUITING
Santiago
Investigational Site Number: 1520002
RECRUITING
Santiago
Investigational Site Number: 1520003
RECRUITING
Santiago
Investigational Site Number: 1520005
RECRUITING
Santiago
China
Investigational Site Number : 1560002
RECRUITING
Chengdu
Investigational Site Number : 1560001
RECRUITING
Guangzhou
Investigational Site Number : 1560005
RECRUITING
Ürümqi
France
Investigational Site Number: 2500001
RECRUITING
Antony
Investigational Site Number: 2500004
RECRUITING
Bezannes
Investigational Site Number : 2500003
RECRUITING
Bordeaux
Investigational Site Number : 2500002
RECRUITING
Lyon
Investigational Site Number : 2500006
RECRUITING
Saint-priest-en-jarez
Investigational Site Number: 2500007
RECRUITING
Toulouse
Germany
Investigational Site Number : 2760002
RECRUITING
Bochum
Investigational Site Number : 2760008
RECRUITING
Bramsche
Investigational Site Number : 2760003
RECRUITING
Frankfurt
Investigational Site Number : 2760005
RECRUITING
Kiel
Investigational Site Number : 2760004
RECRUITING
Mainz
Investigational Site Number : 2760001
RECRUITING
Münster
Investigational Site Number : 2760006
RECRUITING
Würzburg
Greece
Investigational Site Number : 3000001
RECRUITING
Athens
Investigational Site Number : 3000005
RECRUITING
Athens
Investigational Site Number : 3000004
RECRUITING
Thessaloniki
Hungary
Site Number: 3480001
RECRUITING
Debrecen
Investigational Site Number: 3480003
RECRUITING
Pécs
Investigational Site Number : 3480004
RECRUITING
Székesfehérvár
Israel
Investigational Site Number: 3760002
RECRUITING
Jerusalem
Investigational Site Number: 3760001
RECRUITING
Tel Aviv
Italy
Investigational Site Number: 3800002
RECRUITING
Milan
Istituto Dermatologico San Gallicano, IRCCS - Site Number : 3800004
RECRUITING
Roma
Japan
University of the Ryukyus Hospital - Site Number: 3920002
RECRUITING
Nishihara
Meiwa Hospital
RECRUITING
Nishinomiya
Nihon University Itabashi Hospital
RECRUITING
Tokyo
Netherlands
Investigational Site Number : 5280002
RECRUITING
Groningen
Poland
Investigational Site Number: 6160003
RECRUITING
Lodz
Investigational Site Number: 6160002
RECRUITING
Warsaw
Investigational Site Number: 6160001
RECRUITING
Wroclaw
Puerto Rico
Grupo Dermatologico de Carolina- Site Number : 8400023
RECRUITING
Carolina
Spain
Investigational Site Number: 7240004
RECRUITING
Cadiz
Investigational Site Number : 7240007
RECRUITING
Granada
Investigational Site Number: 7240003
RECRUITING
Las Palmas De Gran Canaria
Investigational Site Number: 7240001
RECRUITING
Madrid
Investigational Site Number: 7240005
RECRUITING
Madrid
Investigational Site Number: 7240002
RECRUITING
Manises
Investigational Site Number: 7240006
RECRUITING
Santiago De Compostela
United Kingdom
Investigational Site Number : 8260006
RECRUITING
Leeds
Investigational Site Number : 8260008
RECRUITING
London
Contact Information
Primary
Trial Transparency email recommended (Toll free for US & Canada)
contact-us@sanofi.com
800-633-1610
Time Frame
Start Date: 2025-11-06
Estimated Completion Date: 2028-04-27
Participants
Target number of participants: 208
Treatments
Experimental: Brivekimig dose regimen A
Participants will receive Brivekimig dose regimen A.
Experimental: Brivekimig dose regimen B
Participants will receive Brivekimig dose regimen B.
Experimental: Brivekimig dose regimen C
Participants will receive Brivekimig dose regimen C.
Placebo_comparator: Placebo
Participants will receive Brivekimig matching placebo.
Related Therapeutic Areas
Sponsors
Leads: Sanofi

This content was sourced from clinicaltrials.gov

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