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A Study to Investigate Efficacy and Safety of SAR441566 in Patients With Crohn's Disease.
NCT06637631 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06637631
The ClinicalTrials.gov registry entry for NCT06637631 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 260 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 275 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06637631 reports 20 study locations spanning 14 distinct geographic areas — top geographies include Florida, Illinois, Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06637631?
The interventions under investigation include: SAR441566 (DRUG), SAR441566 matching Placebo (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06637631?
This trial is sponsored by Sanofi, which has 275 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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