A Maintenance Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease (NCT07184944)
A Multicenter, Multinational, Randomized, Double-blind, Placebo-controlled Phase 3, Maintenance Study to Evaluate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease
🩺 Plain-English Summary (8th-Grade Level)
This is a multicenter, randomized, double-blind, placebo-controlled, maintenance, Phase 3 study to evaluate the efficacy and safety of duvakitug in participants with moderately to severely active Crohn's Disease (CD). Study details include: The study duration may be up to 286 weeks including: * 40-week Pivotal Maintenance Sub-Study * 240-week Open-Label Extension (OLE) Sub-Study * 45-day Follow-Up visit Note: For the participants who do not enroll into OLE Sub-Study, the duration will be up to 46 weeks, including the 40-week maintenance period and a 45-day follow-up visit. The treatment duration may be up to 280 weeks including: * 40 weeks in the Pivotal Maintenance Sub-Study * 240 weeks in OLE Sub-Study The total number of on-site visits will be up to 43: - 21 visits in the Pivotal Maintenance Sub-Study - 22 visits in the OLE Sub-Study
Who can join: Review the eligibility criteria below.
Location: Peak Gastroenterology Associates - Colorado Springs-Site Number: 8400039 — Colorado Springs, Colorado
Age range: 16 Years to 80 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 (35 Sites)
Showing the first 25 of 35 sites.
- Peak Gastroenterology Associates - Colorado Springs-Site Number: 8400039 — Colorado Springs, Colorado
- Clinical Research of Osceola-Site Number: 8400013 — Kissimmee, Florida
- Bioresearch Partner-Kendale Lakes-Site Number: 8400053 — Miami, Florida
- NMC Research LLC-Site Number: 8400033 — Tampa, Florida
- Gastroenterology Health Partners, PLLC - New Albany-Site Number: 8400100 — New Albany, Indiana
- GI Alliance - Baton Rouge-Site Number: 8400129 — Baton Rouge, Louisiana
- Texas Digestive Disease Consultants, PLLC d/b/a GI Alliance - Mandeville-Site Number: 8400128 — Mandeville, Louisiana
- Gateway Gastroenterology-Site Number: 8400097 — St Louis, Missouri
- MedTraits NY-Site Number: 8400045 — Maspeth, New York
- NYU Langone Health-Site Number: 8400091 — New York, New York
- Weill Cornell Medicine - NewYork-Presbyterian Hospital-Site Number: 8400040 — New York, New York
- New York Gastroenterology Associates-Site Number: 8400009 — New York, New York
- UNC Hospitals, The University of North Carolina at Chapel Hill-Site Number: 8400074 — Chapel Hill, North Carolina
- Cross Creek Medical Clinic-Site Number: 8400057 — Fayetteville, North Carolina
- Ohio Gastroenterology Group Inc.-Site Number: 8400006 — Columbus, Ohio
- OSU Wexner Medical Center-Site Number: 8400077 — Columbus, Ohio
- North Shore Gastroenterology Research-Site Number: 8400130 — Westlake, Ohio
- University of Pennsylvania School of Medicine-Site Number: 8400072 — Philadelphia, Pennsylvania
- GI Alliance - Lubbock-Site Number: 8400092 — Lubbock, Texas
- Gastroenterology Research of San Antonio LLC-Site Number: 8400054 — San Antonio, Texas
- Tyler Research Institute LLC-Site Number: 8400095 — Tyler, Texas
- Gastroenterology Associates of Western Michigan-Site Number: 8400060 — Wyoming, Wyoming
- Investigational Site Number : 1240009 — Hamilton,
- Investigational Site Number : 1240003 — Toronto,
- Investigational Site Number : 2680008 — Tbilisi,
📞 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.