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

Investigation of the Efficacy and Safety of an Investigational Medication in Adults with Microscopic Colitis

Recruiting
18 years or above
All
Phase 2
54 participants needed
3 Locations

Study Overview

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

You may be eligible for this study if you meet the following criteria:

  • Conditions: Microscopic Colitis
  • Age: 18 years or above
  • Gender: All

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.

This study investigates the efficacy and safety of an investigational medication in adults with microscopic colitis who are in clinical remission. Participants in this study must have a confirmed diagnosis of microscopic colitis and be in clinical remission while receiving budesonide therapy.

Participants will be randomly assigned to receive either the investigational medication or a placebo, which is an inactive substance that looks like the investigational medication but does not contain any medicine. The study is double-blind, meaning neither participants nor researchers will know who is receiving the investigational medication or the placebo. The study will take place across multiple centers and will include regular monitoring of participants' health and symptoms.

  • Who can participate: Adults with a confirmed diagnosis of microscopic colitis who are in clinical remission and have had at least one relapse in the past 8 months may be eligible. They must be receiving budesonide therapy and have a body mass index between 18 and 35 kg/m2.
  • Study details: Participants will be randomly assigned to receive either the investigational medication or a placebo, an inactive substance that looks like the investigational medication but does not contain any medicine. They will continue their current budesonide therapy and attend regular study visits for health monitoring.
  • Study timelines: The study will last approximately 32 weeks.
Updated on 05 Jan 2026. Study ID: NCT07156175

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