NCT07156175
A Study to Investigate the Efficacy and Safety of SAR444336 in Adults With Microscopic Colitis in Clinical Remission
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Record History
All 10 versions: 10 with changes below. See every version on ClinicalTrials.gov ↗
- Minor Enrollment closed, study ongoing
- Final enrollment: 60 participants (planned 54)
- Site details revised at 24 of 24 sites
- Minor Site details revised at 2 of 24 sites
- Notable Eligibility criteria expanded, about 24 words
- Study sites: 26 to 24
- Minor Study sites: 25 to 26v7
- Minor Study sites: 23 to 25v6
Show 4 earlier versionsHide 4 earlier versions
- Minor Study sites: 18 to 23v5
- Minor Study sites revised (18)v4
- Minor Study sites: 11 to 18v3
- Notable Trial status: Not Yet Recruiting to Recruiting
- Study sites: 0 to 11
- Start date changed from estimate of Sep 15, 2025 to Oct 14, 2025
- Study First Submitted
- Notable: the plan changed
- Minor: routine updates
Endpoints
Primary
Proportion of participants with sustained steroid-free clinical remission
Timeframe: up to week 24
Secondary (4)
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
Arms and interventions
SAR444336Experimental
Each participant will receive several injections of SAR444336. Budesonide will be taken at the dose administered by the physician.
PlaceboPlacebo comparator
Each participant will receive several injections of placebo. Budesonide will be taken at the dose administered by the physician.
Drugs: SAR444336, Placebo
Sites
24 sites in 9 countries
Germany 4, Italy 4, France 3, Poland 3, Sweden 3, Denmark 2, Hungary 2, United Kingdom 2, Belgium 1