Phase 2 Study to Evaluate Safety and Effectiveness of Two Doses of SAR445399 Compared to Placebo in Adults with Moderate to Severe Hidradenitis Suppurativa

What this Trial Is About

Researchers are evaluating SAR445399 in adults with moderate to severe hidradenitis suppurativa, a chronic skin condition. This Phase 2, multinational, randomized, double-blind, placebo-controlled study aims to assess the effectiveness and safety of two different doses of SAR445399 compared to placebo. The study is sponsored by Sanofi and involves adult participants who have had symptoms for at least six months and meet specific severity criteria. Participants will be randomly assigned to receive one of two SAR445399 dose regimens or a matching placebo. The study involves a 32-week treatment period, which is divided into a 16-week initial double-blind phase followed by a 16-week treatment-blinded extension phase. SAR445399 and placebo are given by injection. The trial includes a total of 16 visits over approximately 46 weeks. During the study, participants will undergo regular assessments to measure skin improvement, pain levels, quality of life, and safety. Researchers will monitor clinical responses using standardized scales such as the Hidradenitis Suppurativa Clinical Response HiSCR and other quality of life questionnaires. Laboratory tests, vital signs, and ECGs will also be performed. Safety will be tracked throughout the treatment and extension periods, with follow-up visits included in the 46-week study duration.

A Study to Investigate Efficacy and Safety With SAR445399 in Adult Participants With Moderate to Severe Hidradenitis Suppurativa