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Budesonide will be taken at the dose administered by the physician.",[42],"Drug: SAR444336",{"label":44,"type":45,"description":46,"interventionNames":47},"Placebo","PLACEBO_COMPARATOR","Each participant will receive several injections of placebo. 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91",{"type":72,"coordinates":278},[271,272],{"lat":272,"lon":271},{"facility":281,"status":66,"city":282,"state":283,"zip":284,"country":285,"countryCode":286,"cosmosGeoPoint":287,"geoPoint":291,"contacts":16},"Investigational Site Number : 8260002","Cambridge","Cambridgeshire","CB2 2QQ","United Kingdom","UK",{"type":72,"coordinates":288},[289,290],0.11667,52.2,{"lat":290,"lon":289},{"facility":293,"status":66,"city":294,"state":295,"zip":296,"country":285,"countryCode":286,"cosmosGeoPoint":297,"geoPoint":301,"contacts":16},"Investigational Site Number : 8260001","Oxford","Oxfordshire","OX3 9DU",{"type":72,"coordinates":298},[299,300],-1.25596,51.75222,{"lat":300,"lon":299},{"type":303,"investigatorFullName":16,"investigatorTitle":16,"investigatorAffiliation":16,"oldNameTitle":16,"oldOrganization":16},"SPONSOR","100604950","phase-2-a-study-to-investigate-the-efficacy-and-safety-of-sar444336-in-adults-with-microscopic-colitis-in-clinical-remission-100604950",false,"NCT07156175","A Study to Investigate the Efficacy and Safety of SAR444336 in Adults With Microscopic Colitis in Clinical Remission","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","Inclusion Criteria:\n\n* Participants with histologically confirmed diagnosis of microscopic colitis (including all histological sub-types).\n* Receiving budesonide therapy.\n* Documented clinical remission from 2 weeks before screening.\n* At least 1 microscopic colitis relapse in the last 8 months prior to screening that required treatment with budesonide.\n* Body mass index within the range 18 to 35 kg\u002Fm2 (inclusive) at screening visit.\n* All contraceptive methods used by participants should be consistent with local regulations regarding the methods of contraception.\n\nExclusion Criteria:\n\n* Significant neutrophilic\u002Feosinophilic infiltration, crypt abscesses, granulomata, or any evidence of IBD other than microscopic colitis.\n* Evidence of infectious diarrhea in the 3 months prior to randomization.\n* Other active diarrheal conditions or suspicion of drug--induced microscopic colitis at screening, or diarrhea predominant irritable bowel syndrome.\n* Any current active viral, bacterial, or fungal infection or any medically relevant infection having occurred within 3 weeks before randomization.\n* Previous bowel surgeries.\n* Planned surgery while receiving study treatment. Dental surgeries or other types of minor surgery requiring only local anesthetic are allowed.\n* Other immunologic disorder, except controlled diabetes or thyroid disorder receiving appropriate treatment.\n* Presence or history of drug hypersensitivity associated with eosinophilia in the past 6 months.\n* History or presence of alcohol or illicit drug abuse within the past 2 years.\n* Excessive consumption of beverages containing xanthine bases.\n* History of solid organ transplant.\n* 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.\n* 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.\n* 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.\n* Live attenuated vaccines within 6 weeks of randomization and during the study.\n* Currently receiving or had treatment within 12 months prior to screening with B or T cell depleting agents.\n* At screening, have abnormal laboratory values or ECG abnormalities.\n* Participants with recent tuberculosis (TB) vaccination or positive TB test results.\n\nThe above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.","ALL","18 Years",{"count":314,"type":315},54,"ESTIMATED","INTERVENTIONAL",[318],"PHASE2","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.",[321],"Microscopic Colitis","2026-09-18",{"date":324,"type":325},"2026-09-23","ACTUAL",{"date":327,"type":325},"2025-10-14",{"date":329,"type":315},"2027-05-06",{"name":5,"class":6},24]