SAR441566: Pharmaceutical form: Tablet Route of administration: Oral
SAR441566 matching Placebo: Pharmaceutical form: Tablet Route of administration: Oral
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.
| Facility | City | Region | Status |
|---|---|---|---|
| GI Alliance - Arizona Digestive Health - Sun City- Site Number : 8400020 | Sun City | Arizona | |
| Bristol Hospital- Site Number : 8400007 | Bristol | Connecticut | |
| Novum Research- Site Number : 8400021 | Clermont | Florida | |
| Homestead Associates in Research- Site Number : 8400012 | Homestead | Florida | |
| Clinical Research of Osceola- Site Number : 8400013 | Kissimmee | Florida | |
| Wellness Clinical Research - Miami Lakes - 8181 Northwest 154th Street- Site Number : 8400010 | Miami Lakes | Florida | |
| GCP Clinical Research- Site Number : 8400004 | Tampa | Florida | |
| GI Alliance - Glenview- Site Number : 8400015 | Glenview | Illinois | |
| Illinois Gastroenterology Group- Site Number : 8400011 | Gurnee | Illinois | |
| University of Michigan Health System - Ann Arbor- Site Number : 8400017 | Ann Arbor | Michigan | |
| Gi Alliance - Flowood- Site Number : 8400019 | Flowood | Mississippi | |
| Vector Clinical Trials- Site Number : 8400001 | Las Vegas | Nevada | |
| Queens Village Primary Medical Center- Site Number : 8400005 | Queens Village | New York | |
| Carolina Digestive Diseases and Endoscopy Center- Site Number : 8400014 | Greenville | North Carolina | |
| Frontier Clinical Research - Uniontown- Site Number : 8400009 | Uniontown | Pennsylvania | |
| Medical University Of South Carolina - MUSC Health Ashley River Tower - ART- Site Number : 8400016 | Charleston | South Carolina | |
| Gastro Health & Nutrition- Site Number : 8400003 | Katy | Texas | |
| Texas Digestive Disease Consultants - Southlake- Site Number : 8400002 | Southlake | Texas | |
| Washington Gastroenterology - Tacoma- Site Number : 8400008 | Tacoma | Washington | |
| Investigational Site Number : 0320002 | San Miguel de Tucumán | Tucumán Province | |
| Investigational Site Number : 0320003 | Buenos Aires | Argentina | |
| Investigational Site Number : 0320005 | Buenos Aires | Argentina | |
| Investigational Site Number : 0320001 | Buenos Aires | Argentina | |
| Investigational Site Number : 0320004 | Buenos Aires | Argentina | |
| Investigational Site Number : 0320006 | Buenos Aires | Argentina | |
| Investigational Site Number : 0360002 | Sydney | New South Wales | |
| Investigational Site Number : 0360001 | South Brisbane | Queensland | |
| Investigational Site Number : 0360003 | Parkville | Victoria | |
| Centro de Pesquisas da Clínica IBIS- Site Number : 0760001 | Salvador | Estado de Bahia | |
| Hospital Moinhos de Vento- Site Number : 0760006 | Porto Alegre | Rio Grande do Sul | |
| Hospital de Clinicas de Porto Alegre- Site Number : 0760007 | Porto Alegre | Rio Grande do Sul | |
| Hospital Ernesto Dornelles- Site Number : 0760002 | Porto Alegre | Rio Grande do Sul | |
| Pesquisare Saude- Site Number : 0760004 | Santo André | São Paulo | |
| Investigational Site Number : 1000001 | Gorna Oryahovitsa | Bulgaria | |
| Investigational Site Number : 1000004 | Sofia | Bulgaria | |
| Investigational Site Number : 1000005 | Sofia | Bulgaria | |
| Investigational Site Number : 1240001 | Calgary | Alberta | |
| Investigational Site Number : 1240003 | Montreal | Quebec | |
| Investigational Site Number : 1240005 | Québec | Quebec | |
| Investigational Site Number : 1520006 | Concepción | Biobio |
+ 99 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06637631 on ClinicalTrials.gov ↗ ← All trials in India