A Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis or Crohn's Disease
Condition(s) studied
Investigational drug(s) / intervention(s)
Vedolizumab IV: Vedolizumab IV injection.
Vedolizumab SC: Vedolizumab SC injection.
Study summary
The main aim of this study is to learn how the body of a child or teenager with moderately to severely active ulcerative colitis (UC) or Crohn's disease (CD) processes vedolizumab (pharmacokinetics) given just under the skin subcutaneously (SC).
The participants will be treated with vedolizumab for up to 34 weeks.
During the study, participants will visit their study clinic several times.
Eligibility
Primary outcome measure(s)
- Ctrough,ss: Steady-state Median Observed Plasma Concentration at the End of a Dosing Interval for Vedolizumab at Week 34 — Predose at Week 34
- Cavg,ss: Average Serum Concentration at Steady-state for Vedolizumab at Week 34 — Multiple time points prior to Week 34; pre-dose at Week 34
Trial sites (54)
| Facility | City | Region | Status |
|---|---|---|---|
| Phoenix Children's Hospital | Phoenix | Arizona | Not Yet Recruiting |
| Loma Linda University School of Medicine | Loma Linda | California | Active Not Recruiting |
| Children's Hospital Of Orange County | Orange | California | Recruiting |
| Stanford Children's Health | Palo Alto | California | Active Not Recruiting |
| Advocate Children's Hospital | Park Ridge | Illinois | Active Not Recruiting |
| Children's Hospital of Michigan | Detroit | Michigan | Recruiting |
| Atlantic Health System | Morristown | New Jersey | Active Not Recruiting |
| New York Presbyterian Hospital, Weill Cornell Medical College | New York | New York | Active Not Recruiting |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | Active Not Recruiting |
| Cleveland Clinic Foundation | Cleveland | Ohio | Active Not Recruiting |
| The University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | Recruiting |
| Penn State Health Milton S. Hershey Medical Center/ Penn State University College of Medicine | Hershey | Pennsylvania | Active Not Recruiting |
| Medical University of South Carolina | North Charleston | South Carolina | Not Yet Recruiting |
| MultiCare Institute for Research & Innovation | Tacoma | Washington | Not Yet Recruiting |
| Cliniques Universitaires Saint-Luc | Brussels | Belgium | Recruiting |
| Centre Hospitalier Chretien MontLegia | Liège | Belgium | Recruiting |
| University Hospital "Saint George" | Plovdiv | Bulgaria | Recruiting |
| Hvidovre University Hospital | Hvidovre | Capital Region | Active Not Recruiting |
| Childrens Health Ireland | Dublin | Ireland | Active Not Recruiting |
| Azienda Ospedaliera Universitaria Gaetano Martino Messina | Messina | Italy | Recruiting |
| V. Buzzi Hospital | Milan | Italy | Recruiting |
| Unita Operativa Complessa Di Pediatria Medica | Pescara | Italy | Active Not Recruiting |
| IRCCS Ospedale Pediatrico Bambino Gesu | Rome | Italy | Active Not Recruiting |
| Kurume University Hospital | Kurume | Fukuoka | Active Not Recruiting |
| Juntendo University Hospital | Bunkyo-ku | Tokyo | Recruiting |
| National Center for Child Health and Development (NCCHD) | Setagaya-Ku | Tokyo | Active Not Recruiting |
| Radboud University Medical Center | Nijmegen | Netherlands | Active Not Recruiting |
| Instytut Pomnik - Centrum Zdrowia Dziecka | Warsaw | Masovian Voivodeship | Recruiting |
| Korczowski Bartosz, Gabinet Lekarski | Rzeszów | Poland | Recruiting |
| Medical Network Sp. Z.o.o. WIP Warsaw IBD Point Profesor Kierkus | Warsaw | Poland | Recruiting |
| SPSK Nr 1 im. Prof. S. Szyszko SUM w Katowicach | Zabrze | Poland | Active Not Recruiting |
| Hospital Pediatrico - Unidade Local de Saude de Coimbra | Coimbra | Portugal | Active Not Recruiting |
| Hospital St Maria- Centro Hospitalar de Lisboa, Norte EPE | Lisbon | Portugal | Recruiting |
| Centro Materno Infantil do Norte - Unidade Local de Saude de Santo Antonio | Porto | Portugal | Active Not Recruiting |
| "Emergency County Clinical Hospital ""Pius Brinzeu""" | Timișoara | Timiș County | Active Not Recruiting |
| Dr Victor Gomoiu Clinical Children Hospital | Bucharest | Romania | Recruiting |
| Spitalul Clinic de Urgenta Pentru Copii ,,Grigore Alexandrescu, | Bucharest | Romania | Recruiting |
| University Children's Hospital | Belgrade | Serbia | Recruiting |
| Mother and child helath care Institute of Serbia dr Vukan Cupic | Belgrade | Serbia | Active Not Recruiting |
| Institute for Childand YouthHealth Care of Vojvodina | Novi Sad | Serbia | Active Not Recruiting |
+ 14 more sites — see the full list on the official registry below.
More Takeda trials in Italy
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06100289 on ClinicalTrials.gov ↗ ← All trials in Italy