A Phase 2 Study Evaluating the Safety and Effectiveness of SAR444336 Injections in Adults with Microscopic Colitis in Remission on Budesonide Treatment

What this Trial Is About

Researchers are evaluating the efficacy and safety of SAR444336 in adults with microscopic colitis who are currently in clinical remission and receiving budesonide therapy. This is a randomized, double-blind, placebo-controlled, Phase 2 study designed as a proof of concept to better understand this treatment in this patient population. The study is conducted across multiple centers with a total duration of about 32 weeks. Participants will be randomly assigned to receive either SAR444336 or a placebo. Both SAR444336 and placebo are given as several subcutaneous injections. Budesonide will continue to be taken at the dose prescribed by the participants physician. The study includes a treatment period where participants receive these injections while continuing their usual budesonide medication. During the study, participants will be monitored for sustained steroid-free clinical remission up to 24 weeks. Safety assessments will include tracking treatment-emergent adverse events, serious adverse events, and other safety-related outcomes up to 28 weeks. Plasma concentrations of SAR444336 and the presence of anti-drug antibodies will also be measured. Participants will undergo various evaluations throughout the study to assess efficacy and safety, with the entire involvement lasting about 32 weeks.

A Study to Investigate the Efficacy and Safety of SAR444336 in Adults With Microscopic Colitis in Clinical Remission