A Study of Vedolizumab in Children and Teenagers With Moderate to Severe Crohn's Disease (CD) (NCT04779320)
A Randomized, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of Vedolizumab Intravenous as Maintenance Therapy in Pediatric Subjects With Moderately to Severely Active Crohn's Disease Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy
🩺 Plain-English Summary (8th-Grade Level)
Vedolizumab is a medicine that helps to reduce inflammation and pain in the digestive system. In this study, children and teenagers with moderate to severe Crohn's disease will be treated with vedolizumab. The main aim of the study is to check if participants achieve remission after treatment with the vedolizumab. Remission means symptoms improve or disappear and an endoscopy shows no signs of inflammation. Participants will receive 3 infusions of vedolizumab over 6 weeks. Then, those who have a clinical response will receive either a high dose or low dose of vedolizumab once every 8 weeks. They will receive the same dose every time.
Who can join: Review the eligibility criteria below.
Location: Phoenix Childrens Hospital — Phoenix, Arizona
Age range: 2 Years to 17 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 (96 Sites)
Showing the first 25 of 96 sites.
- Phoenix Childrens Hospital — Phoenix, Arizona
- Cedars Sinai Medical Center — Los Angeles, California
- Rady Childrens Hospital San Diego - PIN — San Diego, California
- University of California San Francisco — San Francisco, California
- I.H.S Health LLC — Kissimmee, Florida
- Childrens Center For Digestive Healthcare — Atlanta, Georgia
- Advocate Children's Hospital Park Ridge — Park Ridge, Illinois
- Riley Hospital For Children — Indianapolis, Indiana
- Johns Hopkins University — Baltimore, Maryland
- Boston Children's Hospital — Boston, Massachusetts
- MNGI Digestive Health, PA — Minneapolis, Minnesota
- Mayo Clinic - PIN — Rochester, Minnesota
- Goryeb Children's Hospital — Morristown, New Jersey
- The Steven and Alexandra Cohen Childrens Medical Center of New York - BRANY - PPDS — New Hyde Park, New York
- University of Rochester Medical Center PPDS — Rochester, New York
- Stony Brook University Medical Center — Stony Brook, New York
- SUNY Upstate Medical Center — Syracuse, New York
- University Hospitals Cleveland Medical Center — Cleveland, Ohio
- Children's Hospital of Pittsburgh — Pittsburgh, Pennsylvania
- Hasbro Children's Hospital — Providence, Rhode Island
- Texas Children's Hospital — Houston, Texas
- Carilion Children's Tanglewood Center — Roanoke, Virginia
- Children's Hospital at Westmead — Westmead, New South Wales
- Queensland Childrens Hospital — South Brisbane, Queensland
- Monash Health, Monash Medical Centre — Clayton, Victoria
📞 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 (CD)
- Study Comparing Intravenous (IV)/Subcutaneous (SC) Risankizumab to IV/SC Ustekinumab to Assess Change in Crohn's Disease Activity Index (CDAI) in Adult Participants With Moderate to Severe Crohn's Disease (CD) — Chandler, Arizona
- Comparing Over the Counter Pain Medicines for Discomfort in Crohn's Disease (AVID-CD) — Chapel Hill, North Carolina
- Ultrasound-Guided Versus Standard Margin Selection in Ileocecal Resection of Terminal Ileal CD — Cleveland, Ohio
Explore by condition: All Crohn's Disease (CD) 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.