A Study to Investigate Efficacy and Safety of SAR441566 in Patients With Ulcerative Colitis
Condition(s) studied
Investigational drug(s) / intervention(s)
SAR441566: Pharmaceutical form: Tablet Route of administration: Oral
SAR441566 matching Placebo: Pharmaceutical form: Tablet Route of administration: Oral
Study summary
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.
Eligibility
Primary outcome measure(s)
- Proportion of participants achieving clinical remission at Week 12 by modified Mayo Score (mMS) — Week 12
Clinical remission by modified Mayo score (mMS) is defined as a mMS ≤2 with no subscore \>1 (stool frequency \[SF\] of 0 or 1 with at least a 1-point decrease from baseline, rectal bleeding \[RB\] of 0 and modified Mayo Endoscopic Subscore \[mMES\] of 0 or 1 where 1 does not include friability). Each component of the mMS (SF, RB, and mMES) is scored from 0 to 3. The total mMS ranges from 0 to 9 with higher scores indicating greater disease severity.
Trial sites (117)
| Facility | City | Region | Status |
|---|---|---|---|
| GI Alliance - Arizona Digestive Health - Sun City- Site Number : 8400003 | Sun City | Arizona | |
| Bristol Hospital- Site Number : 8400017 | Bristol | Connecticut | |
| Novum Research- Site Number : 8400018 | Clermont | Florida | |
| Clinical Research of Osceola- Site Number : 8400012 | Kissimmee | Florida | |
| Wellness Clinical Research - Miami Lakes - 8181 Northwest 154th Street- Site Number : 8400002 | Miami Lakes | Florida | |
| GCP Clinical Research- Site Number : 8400016 | Tampa | Florida | |
| GI Alliance - Glenview- Site Number : 8400005 | Glenview | Illinois | |
| Illinois Gastroenterology Group- Site Number : 8400004 | Gurnee | Illinois | |
| University of Michigan Health System - Ann Arbor- Site Number : 8400010 | Ann Arbor | Michigan | |
| Icahn School of Medicine at Mount Sinai- Site Number : 8400001 | New York | New York | |
| Queens Village Primary Medical Center- Site Number : 8400011 | Queens Village | New York | |
| NexGen Research- Site Number : 8400020 | Lima | Ohio | |
| Frontier Clinical Research - Uniontown- Site Number : 8400006 | Uniontown | Pennsylvania | |
| Medical University Of South Carolina - MUSC Health Ashley River Tower - ART- Site Number : 8400008 | Charleston | South Carolina | |
| Gastro Health & Nutrition- Site Number : 8400007 | Katy | Texas | |
| SI Research Associates- Site Number : 8400019 | Lubbock | Texas | |
| Texas Digestive Disease Consultants - Southlake- Site Number : 8400015 | Southlake | Texas | |
| University of Washington Medical Center- Site Number : 8400014 | Seattle | Washington | |
| Washington Gastroenterology - Tacoma- Site Number : 8400009 | Tacoma | Washington | |
| Investigational Site Number : 0320004 | San Miguel de Tucumán | Tucumán Province | |
| Investigational Site Number : 0320003 | Buenos Aires | Argentina | |
| Investigational Site Number : 0320002 | Buenos Aires | Argentina | |
| Investigational Site Number : 0320001 | Buenos Aires | Argentina | |
| Investigational Site Number : 0320005 | Buenos Aires | Argentina | |
| Investigational Site Number : 0360003 | Kurralta Park | South Australia | |
| Investigational Site Number : 0360005 | Richmond | Victoria | |
| Investigational Site Number : 0400002 | Salzburg | Austria | |
| Investigational Site Number : 0400001 | Vienna | Austria | |
| Investigational Site Number : 0560002 | Ghent | Belgium | |
| Investigational Site Number : 0560001 | Leuven | Belgium | |
| Hospital de Clinicas de Porto Alegre- Site Number : 0760002 | Porto Alegre | Rio Grande do Sul | |
| Hospital Ernesto Dornelles- Site Number : 0760003 | Porto Alegre | Rio Grande do Sul | |
| Investigational Site Number : 1000001 | Burgas | Bulgaria | |
| Investigational Site Number : 1000003 | Rousse | Bulgaria | |
| Investigational Site Number : 1000002 | Sofia | Bulgaria | |
| Investigational Site Number : 1240004 | Kentville | Nova Scotia | |
| Investigational Site Number : 1240006 | Ajax | Ontario | |
| Investigational Site Number : 1240005 | Richmond Hill | Ontario | |
| Investigational Site Number : 1240001 | Québec | Quebec | |
| Investigational Site Number : 1520002 | Santiago | Reg Metropolitana de Santiago |
+ 77 more sites — see the full list on the official registry below.
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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 NCT06867094 on ClinicalTrials.gov ↗ ← All trials in France