SAR444336

DRUG3 trials

Sponsors

Sanofi-Aventis Recherche & Developpement, Sanofi

Conditions

Digestive system diseasesHealthy VolunteerMicroscopic Colitis

Phase 1

Tolerability, Pharmacokinetics and Pharmacodynamics of Ascending Single and Repeated Doses of SAR444336 in Healthy Adult Participants

CompletedNCT05876767

SanofiHealthy Volunteer

Start: 2021-10-15End: 2023-12-12Updated: 2025-09-16

Phase 2

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

RecruitingNCT07156175

SanofiMicroscopic Colitis

Start: 2025-10-14End: 2027-05-06Target: 54Updated: 2026-02-24

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.

RecruitingCTIS2024-519495-83-00

Sanofi-Aventis Recherche & DeveloppementDigestive system diseases

Start: 2025-10-28Target: 78Updated: 2025-11-07