A Study of Vedolizumab With and Without Upadacitinib in Adults With Crohn's Disease (NCT06227910)
A Randomized, Double-Blind, Phase 3b Study to Evaluate the Short- and Long-Term Efficacy and Safety of Dual Targeted Therapy With Intravenous Vedolizumab and Oral Upadacitinib Compared With Intravenous Vedolizumab and Oral Placebo for Induction Followed by Intravenous Vedolizumab Monotherapy for Maintenance in the Treatment of Adults With Moderately to Severely Active Crohn's Disease
🩺 Plain-English Summary (8th-Grade Level)
The main aim of this study is to learn whether vedolizumab and upadacitinib given together (also called dual targeted therapy or DTT) reduces bowel inflammation and ulcers in the bowel compared to vedolizumab only (also called monotherapy) in adults with moderately or severely active Crohn's Disease (CD) after 12 weeks of treatment. Other aims are to learn how safe and effective DTT is compared to monotherapy for these participants. All participants will receive DTT (either vedolizumab and upadacitinib or vedolizumab and placebo) for 12 weeks. Participants responding to the treatment will then receive vedolizumab only (monotherapy) for an additional 40 weeks. During the study, participants will visit their study clinic 15 times.
Who can join: Review the eligibility criteria below.
Location: UCSD Medical Center — La Jolla, California
Age range: 18 Years to 65 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 (138 Sites)
Showing the first 25 of 138 sites.
- UCSD Medical Center — La Jolla, California
- Keck Medicine Of USC - USC Healthcare Center 1 — Los Angeles, California
- Peak Gastroenterology Associates — Colorado Springs, Colorado
- GI PROS, Inc. — Naples, Florida
- Orlando Health Ambulatory Care Center — Orlando, Florida
- USF Health Morsani Center for Advanced Healthcare — Tampa, Florida
- Indiana University (IU) Health University Hospital — Indianapolis, Indiana
- University of Kentucky — Lexington, Kentucky
- Mount Sinai Hospital - The Susan and Leonard Feinstein Inflammatory Bowel Disease (IBD) Clinical Center — New York, New York
- Columbia University Medical Center, New York-Presbyterian Hospital — New York, New York
- Lenox Hill Hospital Northwell Health — New York, New York
- Gastroenterology Associates — Greenville, South Carolina
- Rapid City Medical Center — Rapid City, South Dakota
- Southern Star Research Institute, LLC — San Antonio, Texas
- Tyler Research Institute, LLC — Tyler, Texas
- Virginia Mason Medical Center — Seattle, Washington
- Swedish Cancer Institute — Seattle, Washington
- University of Washington Medical Center - Montlake — Seattle, Washington
- Medical College of Wisconsin Cancer Center - Froedtert Hospital — Milwaukee, Wisconsin
- Medizinische Universitaet Wien - Allgemeines Krankenhaus der Stadt Wien (AKH) - Universitaetsklinik fuer Innere Medizin III — Vienna, State of Vienna
- Medical University Innsbruck — Innsbruck, Tyrol
- Johannes Kepler Universitat Linz (JKU) — Linz,
- Landeskrankenhaus Salzburg, Innere Medizin I, Labor im Erdgeschoss — Salzburg,
- Krankenhaus der Barmherzigen Brueder Wien — Vienna,
- Hopital Universitaire de Bruxelles/ Academisch Ziekenhuis Brussel — Brussels, Anderlecht
📞 Contact the Study Coordinator
Phone: (877) 825-3327
Email: medinfoUS@takeda.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.