A Study of Vedolizumab in Children With Ulcerative Colitis (UC) or Crohn's Disease (CD)
Condition(s) studied
Investigational drug(s) / intervention(s)
Vedolizumab IV: Vedolizumab IV infusion
No Intervention: Participants will not receive any intervention in the Observational Cohort.
Study summary
The study is an extension of two parent studies (MLN0002-3024 \[NCT04779307\] and MLN0002-3025 \[NCT04779320\]). Participants must have participated in one of the previous studies. The purpose of this study is to collect the long-term safety of vedolizumab in children with UC or CD.
Eligibility
Primary outcome measure(s)
- Treatment Cohort: Number of Participants With at Least One Adverse Event (AE) — From first dose of study drug up to approximately 5 years
An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have causal relationship with this treatment. AE can be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a drug whether or not it is considered related to drug. - Observational Cohort: Number of Participants With Prespecified Safety Events — Up to approximately 2 years
Prespecified safety events will include serious infections, malignancies, progressive multifocal leukoencephalopathy (PML), concerns about growth and pubertal development, and bowel surgery.
Trial sites (98)
| Facility | City | Region | Status |
|---|---|---|---|
| University of South Alabama (USA) Physicians Group | Mobile | Alabama | Not Yet Recruiting |
| Phoenix Childrens Hospital - Thomas Rd - PIN | Phoenix | Arizona | Recruiting |
| Cedars Sinai Medical Center - 127 San Vicente Blvd | Los Angeles | California | Withdrawn |
| Rady Children's Hospital - San Diego - PIN | San Diego | California | Not Yet Recruiting |
| University of California San Francisco | San Francisco | California | Withdrawn |
| I.H.S Health LLC-Kissimmee-445 W Oak St | Kissimmee | Florida | Withdrawn |
| Childrens Center For Digestive Healthcare | Atlanta | Georgia | Not Yet Recruiting |
| Advocate Children's Hospital - Park Ridge - PIN | Park Ridge | Illinois | Recruiting |
| Riley Hospital For Children - PIN | Indianapolis | Indiana | Withdrawn |
| Johns Hopkins University | Baltimore | Maryland | Withdrawn |
| Boston Children's Hospital - PIN | Boston | Massachusetts | Withdrawn |
| MNGI Digestive Health PA-Plymouth | Minneapolis | Minnesota | Terminated |
| Mayo Clinic - PIN | Rochester | Minnesota | Terminated |
| Goryeb Children's Hospital | Morristown | New Jersey | Terminated |
| Cohen Children's Medical Center Northwell - BRANY - PPDS - PIN | New Hyde Park | New York | Withdrawn |
| University of Rochester Medical Center - PPDS | Rochester | New York | Withdrawn |
| Stony Brook University Medical Center | Stony Brook | New York | Withdrawn |
| University Hospitals Cleveland Medical Center - 11100 Euclid Ave | Cleveland | Ohio | Not Yet Recruiting |
| UPMC Children's Hospital of Pittsburgh - Adolescent Medicine (Oakland) - PIN | Pittsburgh | Pennsylvania | Withdrawn |
| Hasbro Children's Hospital - PIN | Providence | Rhode Island | Withdrawn |
| Texas Children's Hospital - Baylor - PIN | Houston | Texas | Not Yet Recruiting |
| Carilion Children's Tanglewood Center | Roanoke | Virginia | Recruiting |
| Children's Hospital at Westmead | Westmead | New South Wales | Recruiting |
| Queensland Childrens Hospital | South Brisbane | Queensland | Recruiting |
| Monash Health, Monash Medical Centre | Clayton | Victoria | Not Yet Recruiting |
| Royal Children's Hospital Melbourne - PIN | Parkville | Victoria | Recruiting |
| UZ Antwerpen - PIN | Edegem | Antwerpen | Recruiting |
| UZ Brussel - PIN | Jette | Brussels Capital | Recruiting |
| UZ Leuven | Leuven | Vlaams Brabant | Recruiting |
| University of Alberta Hospital | Edmonton | Alberta | Withdrawn |
| British Columbia Children's Hospital - 4480 Oak St | Vancouver | British Columbia | Withdrawn |
| London Health Sciences Centre -800 Commissioners Rd E | London | Ontario | Terminated |
| Centre Hospitalier Universitaire Sainte-Justine | Montreal | Quebec | Withdrawn |
| Beijing Children's Hospital, Capital Medical University - PIN | Beijing | Beijing Municipality | Not Yet Recruiting |
| Henan Children's Hospital Zhengzhou Children's Hospital - Zhengdong Campus | Zhengzhou | Henan | Recruiting |
| Hunan Children's Hospital | Changsha | Hunan | Recruiting |
| Children's Hospital of Fudan University | Shanghai | Shanghai Municipality | Recruiting |
| The Children's Hospital Zhejiang University School of Medicine - Binjiang Campus | Hangzhou | Zhejiang | Recruiting |
| Children's Hospital Zagreb | Zagreb | City of Zagreb | Recruiting |
| University Hospital Center Zagreb | Zagreb | City of Zagreb | Withdrawn |
+ 58 more sites — see the full list on the official registry below.
More Takeda trials in the USA
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 NCT05442567 on ClinicalTrials.gov ↗ ← All trials in the USA