Find Hidradenitis Suppurativa Clinical Trials Near You
A Randomized, Double-blind, Placebo-controlled, Phase 2, Dose-finding Study to Investigate the Efficacy and Safety of SAR445399 in Participants With Moderate to Severe Hidradenitis Suppurativa
Status: Recruiting
Location: See all (20) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
This is a multinational, randomized, double-blind, placebo-controlled, Phase 2, dose finding study to evaluate the efficacy and safety of different doses of SAR445399 in adult participants with moderate to severe hidradenitis suppurativa. The purpose of this study is to assess the efficacy and safety of two doses of SAR445399 compared with placebo in adult participants with moderate to severe hidradenitis suppurativa. The study duration (per participant) will be up to 30 weeks with a total of 12 visits. The treatment duration will be 16 weeks.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
⁃ Participants are eligible to be included in the study only if all of the following criteria apply:
• Participants with a history of signs and symptoms consistent with 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 inguino-crural fold), with at least 1 body site being Hurley Stage II or III.
• Participant must have a total abscess and inflammatory nodule (AN) count of ≥5 at the Baseline Visit.
• Participant must have had an inadequate response to a trial of an oral antibiotic for treatment of HS, exhibited recurrence after discontinuation of antibiotics or 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 in the biologic-naïve stratum must be naïve to any prior use of biologic therapy with a potential impact on HS; Participants in the biologic-experienced stratum must have documented history of use of at least one dose of biologic therapy for HS.
Locations
United States
Arizona
Scottsdale Clinical Trials- Site Number : 8400006
RECRUITING
Scottsdale
California
Carbon Health - North Hollywood - NoHo West- Site Number : 8400017
RECRUITING
North Hollywood
Florida
Encore Medical Research of Boynton Beach- Site Number : 8400005
RECRUITING
Boynton Beach
Alliance for Multispeciality Research - Fort Myers- Site Number : 8400007
RECRUITING
Fort Myers
Encore Medical Research - Hollywood- Site Number : 8400004
RECRUITING
Hollywood
Florida International Research Center- Site Number : 8400002
RECRUITING
Miami
Fxm Clinical Research/Fax Pharma Clinical Research- Site Number : 8400014
RECRUITING
Miami
Kansas
Essential Medical Research- Site Number : 8400015
RECRUITING
Overland Park
New York
Equity Medical- Site Number : 8400010
RECRUITING
New York
Other Locations
China
Investigational Site Number : 1560001
RECRUITING
Beijing
Investigational Site Number : 1560003
RECRUITING
Changsha
Investigational Site Number : 1560002
RECRUITING
Wuhan
Hungary
Investigational Site Number : 3480001
ACTIVE_NOT_RECRUITING
Debrecen
Investigational Site Number : 3480003
RECRUITING
Kaposvár
Spain
Investigational Site Number : 7240006
RECRUITING
Barcelona
Investigational Site Number : 7240002
RECRUITING
Bilbao
Investigational Site Number : 7240001
RECRUITING
Córdoba
Investigational Site Number : 7240004
RECRUITING
Málaga
Sweden
Investigational Site Number : 7520001
RECRUITING
Örebro
Investigational Site Number : 7520002
RECRUITING
Uppsala
Contact Information
Primary
Trial Transparency email recommended (Toll free for US & Canada)
Contact-US@sanofi.com
800-633-1610
Time Frame
Start Date:2025-12-29
Estimated Completion Date:2027-12-01
Participants
Target number of participants:144
Treatments
Experimental: SAR445399 dose regimen A
Participants will receive SAR445399 dose regimen A.
Experimental: SAR445399 dose regimen B
Participants will receive SAR445399 dose regimen B.
Placebo_comparator: Placebo
Participants will receive SAR445399-matching placebo.