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

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 thatrequired 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 localregulations regarding the methods of contraception.

Exclusion Criteria:

• Significant neutrophilic/eosinophilic infiltration, crypt abscesses, granulomata, orany 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 colitisat screening, or diarrhea predominant irritable bowel syndrome.

• Any current active viral, bacterial, or fungal infection or any medically relevantinfection having occurred within 3 weeks before randomization.

• Previous bowel surgeries.

• Planned surgery while receiving study treatment. Dental surgeries or other types ofminor surgery requiring only local anesthetic are allowed.

• Other immunologic disorder, except controlled diabetes or thyroid disorder receivingappropriate treatment.

• Presence or history of drug hypersensitivity associated with eosinophilia in thepast 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 lessthan 2 years, except adequately treated (cured) localized carcinoma in situ of thecervix or ductal breast, or squamous cell carcinoma, or basal cell carcinoma of theskin.

• Have experienced any of the following within 12 months before screening: myocardialinfarction, unstable ischemic heart disease, stroke, or New York Heart AssociationStage III or IV heart failure.

• Participants with a history or presence of another significant illness such asrenal, 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 Tcell 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.