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Recruiting Phase 2

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

NCT07156175 · tracked via the Priya Life Science UK tracker
Sponsor
Phase
Phase 2
Started
2025-10-14
Last updated
2026-10-26

Condition(s) studied

Microscopic Colitis

Investigational drug(s) / intervention(s)

SAR444336Placebo

SAR444336: Pharmaceutical form:Solution for injection -Route of administration:Subcutaneous

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

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Proportion of participants with sustained steroid-free clinical remission — up to week 24
    Clinical remission defined as no relapse during the 24-week period.

Trial sites (24)

FacilityCityRegionStatus
Investigational Site Number : 0560001 Leuven Belgium Recruiting
Investigational Site Number : 2080003 Aarhus Denmark Recruiting
Investigational Site Number : 2080002 Hvidovre Denmark Recruiting
Investigational Site Number : 2500001 Créteil France Recruiting
Investigational Site Number : 2500002 Montfermeil France Recruiting
Investigational Site Number : 2500003 Pessac France Recruiting
Investigational Site Number : 2760001 Frankfurt Germany Recruiting
Investigational Site Number : 2760005 Ludwigshafen Germany Recruiting
Investigational Site Number : 2760003 Tübingen Germany Recruiting
Investigational Site Number : 2760004 Ulm Germany Recruiting
Investigational Site Number : 3480002 Budapest Hungary Recruiting
Investigational Site Number : 3480003 Székesfehérvár Hungary Completed
Investigational Site Number : 3800004 Milan Milano Recruiting
Investigational Site Number : 3800001 Padua Padova Recruiting
Investigational Site Number : 3800003 Rome Roma Recruiting
Investigational Site Number : 3800002 Turin Torino Recruiting
Investigational Site Number : 6160004 Bydgoszcz Kuyavian-Pomeranian Voivodeship Completed
Investigational Site Number : 6160003 Warsaw Masovian Voivodeship Recruiting
Investigational Site Number : 6160002 Warsaw Masovian Voivodeship Recruiting
Investigational Site Number : 7520001 Linköping Sweden Recruiting
Investigational Site Number : 7520002 Stockholm Sweden Recruiting
Investigational Site Number : 7520003 Stockholm Sweden Recruiting
Investigational Site Number : 8260002 Cambridge Cambridgeshire Recruiting
Investigational Site Number : 8260001 Oxford Oxfordshire Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07156175 on ClinicalTrials.gov ↗ ← All trials in the UK