An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease (NCT07184931)
A Multicenter, Multinational, Randomized, Double-blind, Placebo-controlled Phase 3, Induction 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 multinational, multicenter, randomized, double-blind, placebo-controlled, Phase 3 induction study, comprised of 3 sub-studies, to evaluate the efficacy and safety of duvakitug in participants with moderately to severely active CD. Study details include: The study duration may be up to 35 weeks with: * Up to 5-week Screening Period. * 12-week Sub-Study 1 (Single Arm Open-Label Feeder Induction) or Sub-Study 2 (Pivotal Induction). * 12-week Sub-Study 3 (Extended Induction for non-responders). * 6 weeks (45 days) follow-up period for participants who do not enroll into the Pivotal Maintenance Study (EFC18327). The treatment duration will be up to 12 weeks in each sub-study. The number of scheduled study visits for participants who continue to the Pivotal Maintenance Study (EFC18327) will be up to 8 (Sub-Study 1 and Sub-Study 2) and up to 15 for participants who enroll in Sub-Study 3.
Who can join: Review the eligibility criteria below.
Location: Onyx Clinical Research - Site Number: 8400021 — Peoria, Arizona
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 (301 Sites)
Showing the first 25 of 301 sites.
- Onyx Clinical Research - Site Number: 8400021 — Peoria, Arizona
- One of a Kind Clinical Research Center LLC-Site Number: 8400061 — Scottsdale, Arizona
- Del Sol Research Management, LLC-Site Number: 8400012 — Tucson, Arizona
- Preferred Research Partners: 8400018 — Little Rock, Arkansas
- Kagoshima IBD Gastroenterology Clinic - Site Number: 8400008 — Canoga Park, California
- Southern California GI & Liver Centers-Site Number: 8400062 — Coronado, California
- GMC Clinical Research, LLC-Site Number: 8400113 — Folsom, California
- TLC Clinical Research Inc.: 8400030 — Los Angeles, California
- United Medical Doctors CA-Site Number: 8400044 — Murrieta, California
- Prospective Research Innovations Inc.: 8400017 — Rancho Cucamonga, California
- UC Davis Health System-Site Number: 8400071 — Sacramento, California
- Clinical Applications Laboratories Inc-Site Number: 8400056 — San Diego, California
- Medical Associates Research Group-Site Number: 8400063 — San Diego, California
- Valiance Clinical Research - Tarzana: 8400023 — Tarzana, California
- Clinical Trials Management Services-Site Number: 8400047 — Thousand Oaks, California
- Amicis Research Center-Valencia-Site Number: 8400064 — Valencia, California
- Om Research, LLC - Victorville - Site Number: 8400022 — Victorville, California
- Peak Gastroenterology Associates - Colorado Springs-Site Number: 8400039 — Colorado Springs, Colorado
- Gastroenterology of the Rockies - Denver-Site Number: 8400122 — Denver, Colorado
- Novum Research, LLC-Site Number: 8400003 — Clermont, Florida
- Precision Clinical Research: 8400059 — Coral Springs, Florida
- Sarkis Clinical Trials-Ocala-Site Number: 8400048 — Gainesville, Florida
- Clinical Research of Osceola-Site Number: 8400013 — Kissimmee, Florida
- Columbus Clinical Services LLc-Site Number: 8400038 — Miami, Florida
- Regis Clinical Research, LLC-Site Number: 8400041 — Miami, Florida
📞 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.