RecruitingPhase 2NCT07156175

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

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

Sponsor

Sanofi

Enrollment

54 participants

Start Date

Oct 14, 2025

Study Type

INTERVENTIONAL

Conditions

Microscopic Colitis

Summary

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Placebo and a drug called SAR444336 for people with microscopic colitis. The study is currently recruiting participants at 26 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSAR444336

Pharmaceutical form:Solution for injection -Route of administration:Subcutaneous

DRUGPlacebo

Pharmaceutical form:Solution for injection -Route of administration:Subcutaneous

Locations(26)

Investigational Site Number : 0560002

Ghent, Belgium

Investigational Site Number : 0560001

Leuven, Belgium

Investigational Site Number : 2080003

Aarhus, Denmark

Investigational Site Number : 2080002

Hvidovre, Denmark

Investigational Site Number : 2500001

Créteil, France

Investigational Site Number : 2500002

Montfermeil, France

Investigational Site Number : 2500003

Pessac, France

Investigational Site Number : 2760001

Frankfurt, Germany

Investigational Site Number : 2760005

Ludwigshafen, Germany

Investigational Site Number : 2760002

Potsdam, Germany

Investigational Site Number : 2760003

Tübingen, Germany

Investigational Site Number : 2760004

Ulm, Germany

Investigational Site Number : 3480002

Budapest, Hungary

Investigational Site Number : 3480003

Székesfehérvár, Hungary

Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico, Investigational Site Number : 380004

Milan, Milano, Italy

Azienda Ospedale Università Padova, Investigational Site Number : 380001

Padua, Padova, Italy

Fondazione Policlinico Gemelli IRCCS Roma, Investigational Site Number : 380003

Rome, Roma, Italy

A.O.U. Città della Salute e della Scienza di Torino, Presidio Molinette, S.C. Gastroenterologia U., Investigational Site Number : 380002

Turin, Torino, Italy

Investigational Site Number : 6160004

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland

Investigational Site Number : 6160003

Warsaw, Masovian Voivodeship, Poland

Investigational Site Number : 6160002

Warsaw, Masovian Voivodeship, Poland

Investigational Site Number : 7520001

Linköping, Sweden

Investigational Site Number : 7520002

Stockholm, Sweden

Investigational Site Number : 7520003

Stockholm, Sweden

Investigational Site Number : 8260002

Cambridge, Cambridgeshire, United Kingdom

Investigational Site Number : 8260001

Oxford, Oxfordshire, United Kingdom

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NCT07156175

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