Clinical Trial

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

Study acronym: CLAROS
Recruiting Phase 2
View on ClinicalTrials.gov →
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.
Protocol Amendment History 6 changes
notable Trial sites expanded: 63 -> 66 locations 2026-07-02
notable Trial sites expanded: 58 -> 63 locations 2026-06-13
notable Trial sites expanded: 46 -> 58 locations 2026-05-27
notable Trial sites expanded: 43 -> 46 locations 2026-05-05
notable Trial sites expanded: 20 -> 43 locations 2026-04-24
notable Trial sites expanded: 17 -> 20 locations 2026-03-31
Trial Details
NCT Number NCT07225569
Lead Sponsor Sanofi
Conditions Hidradenitis Suppurativa
Enrollment 144 participants
Start Date 2025-12-29
Primary Completion 2027-09-22 (estimated)
Study Completion 2027-12-01 (estimated)
Updated on ClinicalTrials.gov 2026-07-01