A Study of Vedolizumab Intravenous (IV) and Adalimumab or Vedolizumab and Ustekinumab in Adults With Crohn's Disease (NCT06045754)
An Open-Label, Phase 4 Study to Evaluate the Efficacy and Safety of Dual Targeted Therapy With Vedolizumab Intravenous (IV) and Adalimumab Subcutaneous (SC) or Vedolizumab IV and Ustekinumab IV/SC in Moderate to Severe Crohn's Disease (CD)
🩺 Plain-English Summary (8th-Grade Level)
The main aim of this study is to learn about the effect of treatment with vedolizumab IV (vedolizumab) together with adalimumab or vedolizumab (VDZ) together with ustekinumab (UST) in adults with moderate to severe Crohn's Disease, and the effect of treatment with vedolizumab alone, after the dual targeted treatment. The study is conducted in two parts. In Part A, participants will receive the dual targeted treatment (vedolizumab together with either adalimumab or ustekinumab). In part B, participants will receive vedolizumab only. Part B will include participants who responded to the treatment in Part A. Each participant will be followed up for at least 26 weeks after the last dose of treatment.
Who can join: Review the eligibility criteria below.
Location: Digestive Health Specialsits — Dothan, Alabama
Age range: 18 Years to 70 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 (48 Sites)
Showing the first 25 of 48 sites.
- Digestive Health Specialsits — Dothan, Alabama
- GI Alliance Sun City — Sun City, Arizona
- University of California San Diego Health (UCSD) — La Jolla, California
- Cedars-Sinai Medical Center — Los Angeles, California
- Hoag Hospital Newport Beach — Newport Beach, California
- Medical Research Center of Connecticut, LLC — Hamden, Connecticut
- Clinical Research of Osceola — Kissimmee, Florida
- Endoscopic Research Inc — Orlando, Florida
- Alliance Clinical Research of Tampa, LLC — Tampa, Florida
- Gastroenterology Consultants, P.C. — Roswell, Georgia
- University of Chicago Medicine — Chicago, Illinois
- University of Kansas Medical Center — Kansas City, Kansas
- Cotton ONeil Clinical Research Center — Topeka, Kansas
- University of Louisville — Louisville, Kentucky
- GI Alliance — Metairie, Louisiana
- Tulane University — New Orleans, Louisiana
- Huron Gastroenterology Associates, P.C. — Ypsilanti, Michigan
- Mid-America Gastro-Intestinal Consultants — Kansas City, Missouri
- BVL Clinical Research — Liberty, Missouri
- Washington University School of Medicine — St Louis, Missouri
- NYU Langone Health — New York, New York
- University of Cincinnati — Cincinnati, Ohio
- Ohio Gastroenterology group, Inc. — Columbus, Ohio
- Great Lakes Gastroenterology Research, LLC — Mentor, Ohio
- Gastro Intestinal Research Institute of Northern Ohio, LLC. — Westlake, Ohio
📞 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.