A Long-Term Extension Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis (UC) or Crohn's Disease (CD) (NCT06405087)
A Phase 3b Extension Study to Evaluate the Long-term Safety of Vedolizumab Subcutaneous in Pediatric Subjects With Ulcerative Colitis or Crohn's Disease
🩺 Plain-English Summary (8th-Grade Level)
The main aim of this study is to learn about medical problems (adverse events) if vedolizumab subcutaneously (SC) is given to a child or teenager with UC or CD for a long time. Other aims are to understand if the long time use of vedolizumab SC has an impact on the time period until hospital visits because of bowel swelling (inflammation) are needed and has an impact on the quality of life of children and teenagers who received vedolizumab SC. In this study, participants who responded well to the treatment with vedolizumab SC in the parent study (VedolizumabSC-3003 \[NCT06100289\]) will continue to be treated with vedolizumab SC. Participants who did not respond well to the treatment with vedolizumab SC in the parent study or who received corticosteroids in the last 4 weeks of the parent study will not receive vedolizumab SC in this study but will be followed for up to 2 years after the last treatment with vedolizumab SC in the parent study. During the study, participants will visit their study clinic several times.
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 (54 Sites)
Showing the first 25 of 54 sites.
- Phoenix Childrens Hospital — Phoenix, Arizona
- Loma Linda University — Loma Linda, California
- Children's Hospital of Orange County — Orange, California
- Stanford Children's Health — Palo Alto, California
- Advocate Children's Hospital Park Ridge — Park Ridge, Illinois
- Childrens Hospital of Michigan — Detroit, Michigan
- Atlantic Health - Morristown Medical Center — Morristown, New Jersey
- New York Presbyterian Hospital — New York, New York
- University Children's Clinic — Cleveland, Ohio
- Cleveland Clinic — Cleveland, Ohio
- The University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma
- Penn State Health Milton South Hershey Medical Center — Hershey, Pennsylvania
- Medical University of South Carolina — Charleston, South Carolina
- Multicare Health System Institute for Research and Innovation — Tacoma, Washington
- Cliniques Universitaires Saint-Luc — Brussels, Brussels Capital
- Centre Hospitalier Chretien MontLegia — Liège,
- UMHAT Sv. Georgi, EAD — Plovdiv,
- Hvidovre Hospital — Hvidovre, Capital Region
- Childrens Health Ireland at Crumlin - PIN — Crumlin, Dublin
- Azienda Ospedaliera Universitaria Gaetano Martino, Messina — Messina,
- ASST Fatebenefratelli Sacco - Ospedale dei Bambini Vittore Buzzi - INCIPIT - PIN — Milan,
- Unita Operativa Complessa Di Pediatria Medica — Pescara,
- Bambin Gesu Hospital - Ospedale Pediatrico Bambin Gesu — Roma,
- Kurume University Hospital — Kurume-shi, Fukuoka
- Juntendo University Hospital — Bunkyo-ku, Tokyo
📞 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 Ulcerative Colitis
- A Study to Evaluate Efficacy and Safety of Tulisokibart (MK-7240) in Participants With Moderately to Severely Active Ulcerative Colitis (MK-7240-001) — Dothan, Alabama
- Pharmacokinetics of IFX and TNF Concentrations in Serum, Stool, and Colonic Mucosa in Acute Severe Ulcerative Colitis — San Diego, California
- A Study to Evaluate the Safety of Ozanimod Exposure During Pregnancy in Women With Ulcerative Colitis and Their Infants — Eden Prairie, Minnesota
- CP101 for the Treatment of Ulcerative Colitis — Boston, Massachusetts
- A Study on the Safety of TAK-279 and Whether it Can Reduce Inflammation in the Bowel of Participants With Moderately to Severely Active Ulcerative Colitis — Los Angeles, California
- Angiographic Delivery of AD-MSC for Ulcerative Colitis — Rochester, Minnesota
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.