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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
54
Proportion of participants with sustained steroid-free clinical remission
Clinical remission defined as no relapse during the 24-week period.
Time frame: up to week 24
Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs) and adverse events of special interest (AESIs)
Time frame: up to week 28
Incidence of study investigational medicinal product (IMP) permanent discontinuations and study withdrawals due to treatment-emergent adverse events (TEAEs)
Time frame: up to week 28
Plasma concentrations of SAR444336
Time frame: through week 24
Incidence of treatment-emergent anti-drug antibody (ADA) against SAR444336
Time frame: through week 24
Trial Transparency email recommended (Toll free for US & Canada)
CONTACT
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Investigational Site Number : 0560002
Ghent, Belgium
RECRUITINGInvestigational Site Number : 0560001
Leuven, Belgium
RECRUITINGInvestigational Site Number : 2080003
Aarhus, Denmark
RECRUITINGInvestigational Site Number : 2080002
Hvidovre, Denmark
RECRUITINGInvestigational Site Number : 2500001
Créteil, France
RECRUITINGInvestigational Site Number : 2500003
Pessac, France
RECRUITINGInvestigational Site Number : 2760001
Frankfurt am Main, Germany
RECRUITINGInvestigational Site Number : 2760005
Ludwigshafen, Germany
RECRUITINGInvestigational Site Number : 2760002
Potsdam, Germany
RECRUITINGInvestigational Site Number : 2760003
Tübingen, Germany
RECRUITING...and 15 more locations