A Study to Investigate Efficacy and Safety of SAR441566 in Patients With Ulcerative Colitis
Public ClinicalTrials.gov record NCT06867094. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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 Ulcerative Colitis
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT06867094
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 204 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 75 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 27, 2025
- Primary completion
- Jul 28, 2027
- Completion
- May 10, 2028
- Last update posted
- Jun 22, 2026
2025 – 2028
United States locations
- U.S. sites
- 19
- U.S. states
- 11
- U.S. cities
- 19
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| GI Alliance - Arizona Digestive Health - Sun City- Site Number : 8400003 | Sun City | Arizona | 85351 | Recruiting |
| Bristol Hospital- Site Number : 8400017 | Bristol | Connecticut | 06010 | Recruiting |
| Novum Research- Site Number : 8400018 | Clermont | Florida | 34711 | Recruiting |
| Clinical Research of Osceola- Site Number : 8400012 | Kissimmee | Florida | 34741 | Recruiting |
| Wellness Clinical Research - Miami Lakes - 8181 Northwest 154th Street- Site Number : 8400002 | Miami Lakes | Florida | 33016 | Recruiting |
| GCP Clinical Research- Site Number : 8400016 | Tampa | Florida | 33609 | Recruiting |
| GI Alliance - Glenview- Site Number : 8400005 | Glenview | Illinois | 60026 | Recruiting |
| Illinois Gastroenterology Group- Site Number : 8400004 | Gurnee | Illinois | 60031 | Recruiting |
| University of Michigan Health System - Ann Arbor- Site Number : 8400010 | Ann Arbor | Michigan | 48109 | Recruiting |
| Icahn School of Medicine at Mount Sinai- Site Number : 8400001 | New York | New York | 10029 | Recruiting |
| Queens Village Primary Medical Center- Site Number : 8400011 | Queens Village | New York | 11428 | Recruiting |
| NexGen Research- Site Number : 8400020 | Lima | Ohio | 45805 | Recruiting |
| Frontier Clinical Research - Uniontown- Site Number : 8400006 | Uniontown | Pennsylvania | 15401 | Recruiting |
| Medical University Of South Carolina - MUSC Health Ashley River Tower - ART- Site Number : 8400008 | Charleston | South Carolina | 29401 | Recruiting |
| Gastro Health & Nutrition- Site Number : 8400007 | Katy | Texas | 77494 | Recruiting |
| SI Research Associates- Site Number : 8400019 | Lubbock | Texas | 79424 | Recruiting |
| Texas Digestive Disease Consultants - Southlake- Site Number : 8400015 | Southlake | Texas | 76092 | Recruiting |
| University of Washington Medical Center- Site Number : 8400014 | Seattle | Washington | 98195 | Recruiting |
| Washington Gastroenterology - Tacoma- Site Number : 8400009 | Tacoma | Washington | 98405 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 96 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06867094, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 22, 2026 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06867094 live on ClinicalTrials.gov.