Condition: Colitis Ulcerative · Sponsor: Sanofi
This is a Phase 2, multinational, multicenter, randomized, double-blind, placebo-controlled, dose ranging study to evaluate the efficacy and safety of SAR441566 in adults with moderate-to-severe UC. The primary objective of this study is to assess efficacy of different doses of SAR441566 on clinical remission in participants with moderate-to-severe ulcerative colitis. This study will include a screening period of up to 28 days (+ 7 calendar days if needed) followed by the main study treatment period of 52 weeks which will be comprised of a double blind (DB) treatment period with 12 weeks of induction period followed by a maintenance period of 40 weeks and 2-week follow-up after end of treatment. Additionally, an Open Label (OL) period of up to 40 weeks will be offered to eligible participants (for participants not enrolling in the LTS study). * The study duration will be up to 59 weeks. * The treatment duration will be up to 52 weeks in the DB arm and up to 40 weeks in the OL arm. * The number of visits will be 12 for the main study treatment period and 8 for the OL treatment period.
This description comes directly from the study's public registry record.
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Always discuss trial participation with your own doctor first.
| GI Alliance - Arizona Digestive Health - Sun City- Site Number : 8400003 | Sun City, Arizona, United States | Recruiting |
| Bristol Hospital- Site Number : 8400017 | Bristol, Connecticut, United States | Recruiting |
| Novum Research- Site Number : 8400018 | Clermont, Florida, United States | Recruiting |
| Clinical Research of Osceola- Site Number : 8400012 | Kissimmee, Florida, United States | Recruiting |
| Wellness Clinical Research - Miami Lakes - 8181 Northwest 154th Street- Site Number : 8400002 | Miami Lakes, Florida, United States | Recruiting |
| GCP Clinical Research- Site Number : 8400016 | Tampa, Florida, United States | Recruiting |
| GI Alliance - Glenview- Site Number : 8400005 | Glenview, Illinois, United States | Recruiting |
| Illinois Gastroenterology Group- Site Number : 8400004 | Gurnee, Illinois, United States | Recruiting |
| University of Michigan Health System - Ann Arbor- Site Number : 8400010 | Ann Arbor, Michigan, United States | Recruiting |
| Icahn School of Medicine at Mount Sinai- Site Number : 8400001 | New York, New York, United States | Recruiting |
| Queens Village Primary Medical Center- Site Number : 8400011 | Queens Village, New York, United States | Recruiting |
| NexGen Research- Site Number : 8400020 | Lima, Ohio, United States | Recruiting |
+ 103 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT06867094