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A Study to Investigate Efficacy and Safety With SAR445399 in Adult Participants With Moderate to Severe Hidradenitis Suppurativa
Sponsor: Sanofi
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
144
Start Date
2025-12-29
Completion Date
2027-12-01
Last Updated
2026-03-30
Healthy Volunteers
No
Conditions
Interventions
SAR445399
Pharmaceutical form: Solution for injection/infusion -Route of administration: Injection/infusion
Placebo
Pharmaceutical form: Solution for injection -Route of administration: Injection/infusion
Locations (20)
Scottsdale Clinical Trials- Site Number : 8400006
Scottsdale, Arizona, United States
Carbon Health - North Hollywood - NoHo West- Site Number : 8400017
North Hollywood, California, United States
Encore Medical Research of Boynton Beach- Site Number : 8400005
Boynton Beach, Florida, United States
Alliance for Multispeciality Research - Fort Myers- Site Number : 8400007
Fort Myers, Florida, United States
Encore Medical Research - Hollywood- Site Number : 8400004
Hollywood, Florida, United States
Fxm Clinical Research/Fax Pharma Clinical Research- Site Number : 8400014
Miami, Florida, United States
Florida International Research Center- Site Number : 8400002
Miami, Florida, United States
Essential Medical Research- Site Number : 8400015
Overland Park, Kansas, United States
Equity Medical- Site Number : 8400010
New York, New York, United States
Investigational Site Number : 1560001
Beijing, China
Investigational Site Number : 1560003
Changsha, China
Investigational Site Number : 1560002
Wuhan, China
Investigational Site Number : 3480001
Debrecen, Hungary
Investigational Site Number : 3480003
Kaposvár, Hungary
Investigational Site Number : 7240006
Barcelona, Barcelona [Barcelona], Spain
Investigational Site Number : 7240002
Bilbao, Basque Country, Spain
Investigational Site Number : 7240001
Córdoba, Spain
Investigational Site Number : 7240004
Málaga, Spain
Investigational Site Number : 7520001
Örebro, Sweden
Investigational Site Number : 7520002
Uppsala, Sweden