Condition: Crohn's Disease · 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 Crohn's Disease (CD). The primary objective of this study is to assess the efficacy of different doses of SAR441566 compared with placebo in participants with moderate to severe CD. This study will have an anticipated duration of up to 59 weeks which will include a screening period of 4 weeks (+7 calendar days if needed), followed by the Main Study (MS) treatment period, lasting 52 weeks, and a 2-week follow-up period after end of treatment for participants not enrolling in the Long Term Safety (LTS) study. The MS period includes a Double-Blind (DB) treatment period with 12 weeks of induction followed by 40 weeks of maintenance. Additionally, an Open Label (OL) period of up to 40 weeks will be offered to eligible participants. The combined duration of the DB maintenance and OL periods cannot exceed 40 weeks, depending on when participants switch.
This description comes directly from the study's public registry record.
Trial Transparency email recommended (Toll free for US & Canada) · 800-633-1610 · contact-us@sanofi.com
Always discuss trial participation with your own doctor first.
| GI Alliance - Arizona Digestive Health - Sun City- Site Number : 8400020 | Sun City, Arizona, United States | Recruiting |
| Bristol Hospital- Site Number : 8400007 | Bristol, Connecticut, United States | Recruiting |
| Novum Research- Site Number : 8400021 | Clermont, Florida, United States | Recruiting |
| Homestead Associates in Research- Site Number : 8400012 | Homestead, Florida, United States | Recruiting |
| Clinical Research of Osceola- Site Number : 8400013 | Kissimmee, Florida, United States | Recruiting |
| Wellness Clinical Research - Miami Lakes - 8181 Northwest 154th Street- Site Number : 8400010 | Miami Lakes, Florida, United States | Recruiting |
| GCP Clinical Research- Site Number : 8400004 | Tampa, Florida, United States | Recruiting |
| GI Alliance - Glenview- Site Number : 8400015 | Glenview, Illinois, United States | Recruiting |
| Illinois Gastroenterology Group- Site Number : 8400011 | Gurnee, Illinois, United States | Recruiting |
| University of Michigan Health System - Ann Arbor- Site Number : 8400017 | Ann Arbor, Michigan, United States | Recruiting |
| Gi Alliance - Flowood- Site Number : 8400019 | Flowood, Mississippi, United States | Recruiting |
| Vector Clinical Trials- Site Number : 8400001 | Las Vegas, Nevada, United States | Recruiting |
+ 127 more locations — full list on the registry record.
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