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

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Microscopic Colitis

In brief

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.

Key facts

Study ID

NCT07156175

Run by

Sanofi

People needed

54

Starts

2025-10-14

Expected to finish

2027-05-06

Last updated by the study team

2026-02-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants with histologically confirmed diagnosis of microscopic colitis (including all histological sub-types).
• Receiving budesonide therapy.
• Documented clinical remission from 2 weeks before screening.
• At least 1 microscopic colitis relapse in the last 8 months prior to screening that required treatment with budesonide.
• Body mass index within the range 18 to 35 kg/m2 (inclusive) at screening visit.
• All contraceptive methods used by participants should be consistent with local regulations regarding the methods of contraception.

You may not qualify if…

• Significant neutrophilic/eosinophilic infiltration, crypt abscesses, granulomata, or any evidence of IBD other than microscopic colitis.
• Evidence of infectious diarrhea in the 3 months prior to randomization.
• Other active diarrheal conditions or suspicion of drug--induced microscopic colitis at screening, or diarrhea predominant irritable bowel syndrome.
• Any current active viral, bacterial, or fungal infection or any medically relevant infection having occurred within 3 weeks before randomization.
• Previous bowel surgeries.
• Planned surgery while receiving study treatment. Dental surgeries or other types of minor surgery requiring only local anesthetic are allowed.
• Other immunologic disorder, except controlled diabetes or thyroid disorder receiving appropriate treatment.
• Presence or history of drug hypersensitivity associated with eosinophilia in the past 6 months.
• History or presence of alcohol or illicit drug abuse within the past 2 years.
• Excessive consumption of beverages containing xanthine bases.
• History of solid organ transplant.
• Active malignancy, lymphoproliferative disease, or malignancy in remission for less than 2 years, except adequately treated (cured) localized carcinoma in situ of the cervix or ductal breast, or squamous cell carcinoma, or basal cell carcinoma of the skin.
• Have experienced any of the following within 12 months before screening: myocardial infarction, unstable ischemic heart disease, stroke, or New York Heart Association Stage III or IV heart failure.
• Participants with a history or presence of another significant illness such as renal, neurological, ophthalmological, psychiatric, endocrine, cardiovascular, gastrointestinal, hepatic disease, metabolic, pulmonary or lymphatic.
• Live attenuated vaccines within 6 weeks of randomization and during the study.
• Currently receiving or had treatment within 12 months prior to screening with B or T cell depleting agents.
• At screening, have abnormal laboratory values or ECG abnormalities.
• Participants with recent tuberculosis (TB) vaccination or positive TB test results.
• The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Where it is running

• Investigational Site Number : 0560002 — Ghent, Belgium (enrolling)
• Investigational Site Number : 0560001 — Leuven, Belgium (enrolling)
• Investigational Site Number : 2080003 — Aarhus, Denmark (enrolling)
• Investigational Site Number : 2080002 — Hvidovre, Denmark (enrolling)
• Investigational Site Number : 2500001 — Créteil, France (enrolling)
• Investigational Site Number : 2500002 — Montfermeil, France (enrolling)
• Investigational Site Number : 2500003 — Pessac, France (enrolling)
• Investigational Site Number : 2760001 — Frankfurt, Germany (enrolling)
• Investigational Site Number : 2760005 — Ludwigshafen, Germany (enrolling)
• Investigational Site Number : 2760002 — Potsdam, Germany (enrolling)
• Investigational Site Number : 2760003 — Tübingen, Germany (enrolling)
• Investigational Site Number : 2760004 — Ulm, Germany (enrolling)
• Investigational Site Number : 3480002 — Budapest, Hungary (enrolling)
• Investigational Site Number : 3480003 — Székesfehérvár, Hungary (enrolling)
• Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico, Investigational Site Number : 380004 — Milan, Milano, Italy (enrolling)
• Azienda Ospedale Università Padova, Investigational Site Number : 380001 — Padua, Padova, Italy (enrolling)
• Fondazione Policlinico Gemelli IRCCS Roma, Investigational Site Number : 380003 — Rome, Roma, Italy (enrolling)
• A.O.U. Città della Salute e della Scienza di Torino, Presidio Molinette, S.C. Gastroenterologia U., Investigational Site Number : 380002 — Turin, Torino, Italy (enrolling)
• Investigational Site Number : 6160004 — Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland (enrolling)
• Investigational Site Number : 6160003 — Warsaw, Masovian Voivodeship, Poland (enrolling)
• Investigational Site Number : 6160002 — Warsaw, Masovian Voivodeship, Poland (enrolling)
• Investigational Site Number : 7520001 — Linköping, Sweden (enrolling)
• Investigational Site Number : 7520002 — Stockholm, Sweden (enrolling)
• Investigational Site Number : 7520003 — Stockholm, Sweden (enrolling)
• Investigational Site Number : 8260002 — Cambridge, Cambridgeshire, United Kingdom (enrolling)

Full record on ClinicalTrials.gov

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