*ACT18053

• Research type

  Research Study

• Full title

  A randomized, double-blind, placebo-controlled, parallel-group study to assess the efficacy, safety, and tolerability of SAR444336 in participants with microscopic colitis in clinical remission with budesonide

• IRAS ID

  1011540

• Contact name

  Patrick Maury

• Contact email

  Patrick.Maury@Sanofi.com

• Sponsor organisation

  Sanofi-Aventis Recherche & Développement

• Research summary

  This study aims to investigate whether SAR444336, a new medication that works by increasing regulatory T cells in the body, can help maintain remission in patients with microscopic colitis who have achieved remission with budesonide treatment. Microscopic colitis is a condition that causes chronic watery diarrhea, particularly affecting older women. While budesonide (a steroid) is effective for inducing remission, many patients relapse when treatment stops. This study will evaluate if SAR444336 can provide a steroid-free alternative for maintaining remission, potentially improving quality of life for patients and reducing the risks associated with long-term steroid use.

• REC name

  South Central - Berkshire B Research Ethics Committee

• REC reference

  25/SC/0092

• Date of REC Opinion

  31 Jul 2025

• REC opinion

  Further Information Favourable Opinion