This is a parallel, placebo-controlled, multicenter, randomized, double-blind, Phase 2, proof of concept study. The study aims to evaluate the efficacy and safety of SAR444336 in adult participants with microscopic colitis. Participants are required to have a histologically confirmed diagnosis of microscopic colitis, be in clinical remission and be receiving budesonide therapy. The overall study duration is approximately 32 weeks.
Protocol Amendment History
6 amendments
This ClinicalTrials.gov record has been amended 6 times since 2025-09-03; most recent amendment 2026-02-23.
Status change: Not Yet Recruiting → Recruiting2025-11-10