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A Study to Investigate the Efficacy and Safety of SAR444336 in Adults With Microscopic Colitis in Clinical Remission
A Study to Investigate the Efficacy and Safety of SAR444336 in Adults With Microscopic Colitis in Clinical Remission
RecruitingPhase 2
Sponsor: Sanofi
Conditions: Microscopic Colitis
Interventions: SAR444336, Placebo
Countries: Belgium, Denmark, France, Germany, Hungary, Italy, Poland, Sweden
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 overview
Sex: ALL
Age: 18 Years to —
Healthy volunteers: No
Study type: INTERVENTIONAL
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.
Locations (26)
- Ghent, Belgium
- Leuven, Belgium
- Aarhus, Denmark
- Hvidovre, Denmark
- Créteil, France
- Montfermeil, France
- Pessac, France
- Frankfurt, Germany
- Ludwigshafen, Germany
- Potsdam, Germany
- Tübingen, Germany
- Ulm, Germany
- Budapest, Hungary
- Székesfehérvár, Hungary
- Milan, Milano, Italy
- Padua, Padova, Italy
- Rome, Roma, Italy
- Turin, Torino, Italy
- Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
- Warsaw, Masovian Voivodeship, Poland
- Warsaw, Masovian Voivodeship, Poland
- Linköping, Sweden
- Stockholm, Sweden
- Stockholm, Sweden
- Cambridge, Cambridgeshire, United Kingdom
- Oxford, Oxfordshire, United Kingdom