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
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 46 weeks with a total of 16 visits. The treatment duration will be 32 weeks which includes 16-week double-blinded initial treatment period and a 16-week treatment-blinded extension period.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 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…
Interventions
- DrugSAR445399
Pharmaceutical form: Solution for injection -Route of administration: Injection
- DrugPlacebo
Pharmaceutical form: Solution for injection -Route of administration: Injection
Locations (46)
- Scottsdale Clinical Trials- Site Number : 8400006Scottsdale, Arizona
- Carbon Health - North Hollywood - NoHo West- Site Number : 8400017North Hollywood, California
- Encore Medical Research of Boynton Beach- Site Number : 8400005Boynton Beach, Florida
- FXM Clinical Research - Fort Lauderdale- Site Number : 8400013Fort Lauderdale, Florida
- Alliance for Multispeciality Research - Fort Myers- Site Number : 8400007Fort Myers, Florida
- Encore Medical Research - Hollywood- Site Number : 8400004Hollywood, Florida