A Study to Investigate Efficacy and Safety of SAR441566 in Patients With Ulcerative Colitis
Phase 2
204
about 3.1 years
18–75
18 sites in AZ, CT, FL +7
What this study is about
This trial is testing a treatment called SAR441566 for people with ulcerative colitis. The goal is to see if this treatment helps improve symptoms and is safe to use. Participants will receive either SAR441566 or a placebo (inactive pill) for up to 52 weeks, along with an optional open-label period.
Simplified from trial records by PatientMatch.
What you may be asked to do
- 1.Take SAR441566
- 2.Take SAR441566 matching Placebo
Participation Burden
What's physically and logistically required of participants.
Requires travel to a study site
How treatment is administered
You may get a placebo/standard care, and you won't know which.
Extracted study details
Pulled from the trial record to show what is being tested and what the study is measuring.
Secondary: Change from baseline in PRO2 from randomization to Week 12, Number of participants with any treatment-emergent adverse events (TEAEs) during induction and maintenance treatment period, Number of participants with any treatment-emergent adverse events (TEAEs) during open-label treatment period, Proportion of participants achieving the combination of patient-reported outcome 2 (PRO2) remission and endoscopic remission at Week 12
Gastroenterology