A Study to Investigate Efficacy and Safety of SAR441566 in Patients With Crohn's Disease.
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Official title
A Phase 2, Multinational, Multicenter, Randomized, Doubleblind, Placebocontrolled, Dose-ranging Study to Evaluate the Efficacy and Safety of SAR441566 in Adults With Moderate to Severe Crohn's Disease.
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 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.
Study identification
- NCT ID
- NCT06637631
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 105 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
- Dec 10, 2024 (Actual)
- Primary completion
- Jul 30, 2026 (Actual)
- Completion
- Oct 2, 2026 (Actual)
- Last update posted
- Oct 13, 2026
2024 – 2026
United States locations
- U.S. sites
- 19
- U.S. states
- 13
- U.S. cities
- 19
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| GI Alliance - Arizona Digestive Health - Sun City- Site Number : 8400020 | Sun City | Arizona | 85351 | — |
| Bristol Hospital- Site Number : 8400007 | Bristol | Connecticut | 06010 | — |
| Novum Research- Site Number : 8400021 | Clermont | Florida | 34711 | — |
| Homestead Associates in Research- Site Number : 8400012 | Homestead | Florida | 33033 | — |
| Clinical Research of Osceola- Site Number : 8400013 | Kissimmee | Florida | 34741 | — |
| Wellness Clinical Research - Miami Lakes - 8181 Northwest 154th Street- Site Number : 8400010 | Miami Lakes | Florida | 33016 | — |
| GCP Clinical Research- Site Number : 8400004 | Tampa | Florida | 33609 | — |
| GI Alliance - Glenview- Site Number : 8400015 | Glenview | Illinois | 60026 | — |
| Illinois Gastroenterology Group- Site Number : 8400011 | Gurnee | Illinois | 60031 | — |
| University of Michigan Health System - Ann Arbor- Site Number : 8400017 | Ann Arbor | Michigan | 48109 | — |
| Gi Alliance - Flowood- Site Number : 8400019 | Flowood | Mississippi | 39232 | — |
| Vector Clinical Trials- Site Number : 8400001 | Las Vegas | Nevada | 89128 | — |
| Queens Village Primary Medical Center- Site Number : 8400005 | Queens Village | New York | 11428 | — |
| Carolina Digestive Diseases and Endoscopy Center- Site Number : 8400014 | Greenville | North Carolina | 27834 | — |
| Frontier Clinical Research - Uniontown- Site Number : 8400009 | Uniontown | Pennsylvania | 15401 | — |
| Medical University Of South Carolina - MUSC Health Ashley River Tower - ART- Site Number : 8400016 | Charleston | South Carolina | 29401 | — |
| Gastro Health & Nutrition- Site Number : 8400003 | Katy | Texas | 77494 | — |
| Texas Digestive Disease Consultants - Southlake- Site Number : 8400002 | Southlake | Texas | 76092 | — |
| Washington Gastroenterology - Tacoma- Site Number : 8400008 | Tacoma | Washington | 98405 | — |
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 122 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06637631, 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 Oct 13, 2026 · Synced Nov 14, 2026
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