An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis (NCT07184996)
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 Ulcerative Colitis.
🩺 Plain-English Summary (8th-Grade Level)
This is a multinational, multicenter, randomized, double-blind, placebo-controlled, Phase 3 induction study to evaluate the efficacy and safety of duvakitug in participants with moderately to severely active Ulcerative Colitis (UC). Study details include: The study duration may be up to 35 weeks with: * 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) * 45 days follow-up visit for participants who do not enroll into the maintenance study (EFC18359) The treatment duration will be up to 12 weeks in each sub-study. The number of scheduled on-site visits will be up to 8 for the Sub-Study 1 and Sub Study 2 or a maximum of 15 visits for participants completing extended induction.
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 (219 Sites)
Showing the first 25 of 219 sites.
- Onyx Clinical Research - Site Number: 8400021 — Peoria, Arizona
- One of a Kind Clinical Research Center LLC - Site Number: 8400061 — Scottsdale, Arizona
- Scottsdale Clinical Trials - Site Number: 8400145 — Scottsdale, Arizona
- Del Sol Research Management, LLC - Site Number: 8400012 — Tucson, Arizona
- Preferred Research Partners - Site Number: 8400018 — Little Rock, Arkansas
- FOMAT - Unio Specialty Care Arcadia - Site Number: 8400027 — Arcadia, California
- Alliance Research Institute - 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
- Om Research, LLC - Lancaster - Site Number: 8400148 — Lancaster, California
- TLC Clinical Research Inc. - Site Number: 8400030 — Los Angeles, California
- United Medical Doctors CA - Site Number: 8400044 — Murrieta, California
- Om Research, LLC - Oxnard - Site Number: 8400150 — Oxnard, 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
- Santa Maria Gastroenterology - FOMAT Medical Research HyperCORE - Site Number: 8400025 — Santa Maria, California
- Valiance Clinical Research - Tarzana - Site Number: 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
- UCHealth Digestive Health Center - Anschutz Medical Campus - Site Number: 8400085 — Aurora, Colorado
- Peak Gastroenterology Associates - Colorado Springs - Site Number: 8400039 — Colorado Springs, Colorado
- Gastroenterology of the Rockies - Denver - Site Number: 8400122 — Denver, Colorado
- Yale University Digestive Disease - Site Number: 8400108 — New Haven, Connecticut
📞 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.
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- A Study to Evaluate the Safety of Ozanimod Exposure During Pregnancy in Women With Ulcerative Colitis and Their Infants — Eden Prairie, Minnesota
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Explore by condition: All Ulcerative Colitis 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.