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SAR444336 to help adults with microscopic colitis stay in remission while on budesonide.

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

Phase 2 Interventional Sanofi · NCT07156175

This will test whether adding SAR444336 to budesonide helps adults with microscopic colitis who are in remission stay symptom-free longer than placebo.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment54 (estimated)
Ages18 Years and up
SexAll
SponsorSanofi Industry-sponsored
Locations26 sites (Ghent and 25 other locations)
Trial IDNCT07156175 on ClinicalTrials.gov

What this trial studies

This multicenter, randomized, double-blind, parallel, placebo-controlled Phase 2 proof-of-concept trial compares SAR444336 versus placebo in adults with histologically confirmed microscopic colitis who are in clinical remission while receiving budesonide. Eligible participants must have had at least one relapse in the prior 8 months and meet BMI and contraception requirements. Participants are randomized and followed for approximately 32 weeks to monitor maintenance of remission, relapse rates, symptoms, and safety. The study focuses on whether SAR444336 can prolong remission and documents adverse events.

Who should consider this trial

Good fit: Adults with histologically confirmed microscopic colitis who are in clinical remission, currently taking budesonide, and who had at least one relapse in the past 8 months are ideal candidates.

Not a fit: Patients with active infectious diarrhea, other forms of inflammatory bowel disease, drug-induced microscopic colitis, significant neutrophilic or eosinophilic infiltration on biopsy, or who are not on budesonide are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, SAR444336 could reduce relapse rates and help patients remain in remission with less need for repeated steroid courses.

How similar studies have performed: This is a Phase 2 proof-of-concept effort and biologic therapies for microscopic colitis have limited prior evidence, so the approach is relatively novel for this condition.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Ghent and 25 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Microscopic Colitis
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.