A Study to Investigate Efficacy and Safety of SAR441566 in Patients With Crohn's Disease. (NCT06637631)
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.
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: GI Alliance - Arizona Digestive Health - Sun City- Site Number : 8400020 — Sun City, Arizona
Age range: 18 Years to 75 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (139 Sites)
Showing the first 25 of 139 sites.
- GI Alliance - Arizona Digestive Health - Sun City- Site Number : 8400020 — Sun City, Arizona
- Bristol Hospital- Site Number : 8400007 — Bristol, Connecticut
- Novum Research- Site Number : 8400021 — Clermont, Florida
- Homestead Associates in Research- Site Number : 8400012 — Homestead, Florida
- Clinical Research of Osceola- Site Number : 8400013 — Kissimmee, Florida
- Wellness Clinical Research - Miami Lakes - 8181 Northwest 154th Street- Site Number : 8400010 — Miami Lakes, Florida
- GCP Clinical Research- Site Number : 8400004 — Tampa, Florida
- GI Alliance - Glenview- Site Number : 8400015 — Glenview, Illinois
- Illinois Gastroenterology Group- Site Number : 8400011 — Gurnee, Illinois
- University of Michigan Health System - Ann Arbor- Site Number : 8400017 — Ann Arbor, Michigan
- Gi Alliance - Flowood- Site Number : 8400019 — Flowood, Mississippi
- Vector Clinical Trials- Site Number : 8400001 — Las Vegas, Nevada
- Queens Village Primary Medical Center- Site Number : 8400005 — Queens Village, New York
- Carolina Digestive Diseases and Endoscopy Center- Site Number : 8400014 — Greenville, North Carolina
- Frontier Clinical Research - Uniontown- Site Number : 8400009 — Uniontown, Pennsylvania
- Medical University Of South Carolina - MUSC Health Ashley River Tower - ART- Site Number : 8400016 — Charleston, South Carolina
- Gastro Health & Nutrition- Site Number : 8400003 — Katy, Texas
- Texas Digestive Disease Consultants - Southlake- Site Number : 8400002 — Southlake, Texas
- Washington Gastroenterology - Tacoma- Site Number : 8400008 — Tacoma, Washington
- Investigational Site Number : 0320002 — San Miguel de Tucumán, Tucumán Province
- Investigational Site Number : 0320003 — Buenos Aires,
- Investigational Site Number : 0320005 — Buenos Aires,
- Investigational Site Number : 0320001 — Buenos Aires,
- Investigational Site Number : 0320004 — Buenos Aires,
- Investigational Site Number : 0320006 — Buenos Aires,
📞 Contact the Study Coordinator
Phone: (800) 633-1610
Email: contact-us@sanofi.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Crohn's Disease
- A Non-Interventional Clinical Study to Evaluate Long-Term Safety and Effectiveness of HUMIRA (Adalimumab) in Pediatric Patients With Moderately to Severely Active Crohn's Disease (CD) — Birmingham, Alabama
- A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Crohn's Disease — Birmingham, Alabama
- A Study to Assess Adverse Events and Change in Disease Activity of Risankizumab Subcutaneous Induction Treatment for Moderately to Severely Active Crohn's Disease. — Sun City, Arizona
- Study to Assess Speed of Onset and Durability of Effectiveness of Upadacitinib in Adult Participants With Moderate to Severe Crohn's Disease (CD) in Real World Clinical Practice. — Blacktown, New South Wales
- Transmural Healing and Disease-Modifying Effect of Guselkumab in Crohn's Disease Patients — San Francisco, California
- Dietary Therapy and Gut Microbiome in Crohn's Disease and Ulcerative Colitis — Boston, Massachusetts
Explore by condition: All Crohn's Disease clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.