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.
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.
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.
Parallel
SAR444336
DrugPharmaceutical form:Solution for injection -Route of administration:Subcutaneous
Placebo
DrugPharmaceutical form:Solution for injection -Route of administration:Subcutaneous
Proportion of participants with sustained steroid-free clinical remission
Clinical remission defined as no relapse during the 24-week period.
Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs) and adverse events of special interest (AESIs)
Incidence of study investigational medicinal product (IMP) permanent discontinuations and study withdrawals due to treatment-emergent adverse events (TEAEs)
Plasma concentrations of SAR444336
Incidence of treatment-emergent anti-drug antibody (ADA) against SAR444336
