NCT07156175 A Study to Investigate the Efficacy and Safety of SAR444336 in Adults With Microscopic Colitis in Clinical Remission

Eligibility & Interventions

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.

This trial targets 54 participants in total. It began in 2025-10-14 with a primary completion date of 2027-04-08.

Brief 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 Criteria

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Contact & Investigator

Frequently Asked Questions

Related Trials