A Long-Term Extension Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis (UC) or Crohn's Disease (CD)
Recruiting now · Phase 3
Conditions studied: Ulcerative Colitis, Crohn's Disease
In brief
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.
Key facts
- Study ID
- NCT06405087
- Run by
- Takeda
- People needed
- 70
- Starts
- 2025-10-27
- Expected to finish
- 2030-08-12
- Last updated by the study team
- 2026-06-22
Who can join
Age: 2 and older, up to 17. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Seoul National University Hospital — Seoul, South Korea (enrolling)
- UMHAT Sv. Georgi, EAD — Plovdiv, Bulgaria (enrolling)
- Kyungpook National University Chilgok hospital — Daegu, South Korea (enrolling)
- The University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma, United States (enrolling)
- Instytut Pomnik - Centrum Zdrowia Dziecka — Warsaw, Poland (enrolling)
- Korczowski Bartosz, Gabinet Lekarski — Rzeszów, Poland (enrolling)
- WIP Warsaw IBD Point Profesor Kierkus — Warsaw, Poland (enrolling)
- Grigore Alexandrescu Emergency Clinical Hospital for Children — Bucharest, Romania (enrolling)
- University Hospital of Bern — Bern, Switzerland (enrolling)
- Juntendo University Hospital — Bunkyo-ku, Tokyo, Japan (enrolling)
- Severance Hospital, Yonsei University Health System — Seoul, South Korea (enrolling)
- Victor Gomoiu Clinical Hospital for Children — Bucharest, Bucharest, Romania (enrolling)
- Cliniques Universitaires Saint-Luc — Brussels, Brussels Capital, Belgium
- Multicare Health System Institute for Research and Innovation — Tacoma, Washington, United States
- Atlantic Health - Morristown Medical Center — Morristown, New Jersey, United States
- Medical University of South Carolina — Charleston, South Carolina, United States
- Penn State Health Milton South Hershey Medical Center — Hershey, Pennsylvania, United States
- Childrens Hospital of Michigan — Detroit, Michigan, United States
- Children's Hospital of Orange County — Orange, California, United States
- Bambin Gesu Hospital - Ospedale Pediatrico Bambin Gesu — Roma, Italy
- Unita Operativa Complessa Di Pediatria Medica — Pescara, Italy
- ASST Fatebenefratelli Sacco - Ospedale dei Bambini Vittore Buzzi - INCIPIT - PIN — Milan, Italy
- Kurume University Hospital — Kurume-shi, Fukuoka, Japan
- Azienda Ospedaliera Universitaria Gaetano Martino, Messina — Messina, Italy
- Cleveland Clinic — Cleveland, Ohio, United States
Full record on ClinicalTrials.gov
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