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NCT06637631 · ClinicalTrials.gov registry record · Phase 2
A Study to Investigate Efficacy and Safety of SAR441566 in Patients With Crohn's Disease.
A Phase 2 study of Crohn's Disease, sponsored by Sanofi.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 260
- Enrollment target
- 20
- Study locations
NCT06637631: Recruiting Phase 2 study of Crohn's Disease, sponsored by Sanofi.
NCT06637631 is a Phase 2 study of Crohn's Disease that is actively recruiting participants, run by Sanofi. The registered enrollment target is 260 participants, below the 2,392-participant average among 105 other Crohn's Disease trials with a reported enrollment target (89% lower). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06637631, a Phase 2 study of Crohn's Disease, is actively recruiting participants, sponsored by Sanofi.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 260 participants
- Enrollment target
- 20
- Study locations
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 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.
Primary Outcome
Endoscopic response is defined as ≥50% reduction from baseline in centrally read Simple Endoscopic Score for Crohn's Disease (SES-CD). The SES-CD evaluates 4 endoscopic variables (ulcer size, ulcerated surface, affected surface, and narrowing, each on a scale from 0 (none) to 3 in 5 segments assessed during ileocolonoscopy (ileum, right colon, transverse colon, sigmoid and left colon, and rectum). The total score is the sum of the 4 endoscopic variable scores and ranges from 0 to 56, where high
Conditions Studied
Interventions
- DRUG SAR441566
- DRUG SAR441566 matching Placebo
Study Locations (20)
Florida
- Novum Research- Site Number : 8400021 - Clermont
- Homestead Associates in Research- Site Number : 8400012 - Homestead
- Clinical Research of Osceola- Site Number : 8400013 - Kissimmee
- Wellness Clinical Research - Miami Lakes - 8181 Northwest 154th Street- Site Number : 8400010 - Miami Lakes
- GCP Clinical Research- Site Number : 8400004 - Tampa
Illinois
- GI Alliance - Glenview- Site Number : 8400015 - Glenview
- Illinois Gastroenterology Group- Site Number : 8400011 - Gurnee
Texas
- Gastro Health & Nutrition- Site Number : 8400003 - Katy
- Texas Digestive Disease Consultants - Southlake- Site Number : 8400002 - Southlake
Arizona
- GI Alliance - Arizona Digestive Health - Sun City- Site Number : 8400020 - Sun City
Connecticut
- Bristol Hospital- Site Number : 8400007 - Bristol
Michigan
- University of Michigan Health System - Ann Arbor- Site Number : 8400017 - Ann Arbor
Mississippi
- GI Alliance - Flowood- Site Number : 8400019 - Flowood
Nevada
- Vector Clinical Trials- Site Number : 8400001 - Las Vegas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 260 participants |
| Start Date | 2024-12-10 |
| Est. Completion | 2029-05-23 |
| Phase | Phase 2 |
What NCT06637631 shows while recruiting
NCT06637631 is an interventional study that assigns participants to a tested intervention. The registered 260 participants enrollment target is mid-sized for trials with a published cap, below the 2,392-participant average among 105 other Crohn's Disease trials with a reported enrollment target (89% lower).
The record links to 1 condition, with Crohn's Disease appearing as the primary indexed condition, and to 2 interventions - of which SAR441566 is the first listed.
NCT06637631 names 20 study sites across 14 states, led by Florida, Illinois, Texas.
Frequently Asked Questions
What is clinical trial NCT06637631 about?
NCT06637631 is a clinical study titled "A Study to Investigate Efficacy and Safety of SAR441566 in Patients With Crohn's Disease.". 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...
What is the current status of trial NCT06637631?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 260 participants. The study started on 2024-12-10. Estimated completion is 2029-05-23.
What conditions does trial NCT06637631 study?
This clinical trial studies the following conditions: Crohn's Disease.
What interventions are being tested in trial NCT06637631?
The interventions under investigation include: SAR441566 (DRUG), SAR441566 matching Placebo (DRUG).
Who is sponsoring clinical trial NCT06637631?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06637631 being conducted?
This trial has 20 study locations across Arizona, Connecticut, Florida, Illinois, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06637631's enrollment target sits among peer trials
260 46th of 105 higher than 60 of 105 other Crohn's Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Crohn's Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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