A Study of Vedolizumab in Children With Ulcerative Colitis (UC) or Crohn's Disease (CD)
Public ClinicalTrials.gov record NCT05442567. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 3b Extension Study to Evaluate the Long-term Safety of Vedolizumab Intravenous in Pediatric Patients With Ulcerative Colitis or Crohn's Disease
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05442567
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 240 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 2 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 15, 2023
- Primary completion
- Feb 6, 2033
- Completion
- Feb 6, 2033
- Last update posted
- May 6, 2026
2023 – 2033
United States locations
- U.S. sites
- 22
- U.S. states
- 17
- U.S. cities
- 22
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of South Alabama (USA) Physicians Group | Mobile | Alabama | 36604 | Not yet recruiting |
| Phoenix Childrens Hospital - Thomas Rd - PIN | Phoenix | Arizona | 85016 | Recruiting |
| Cedars Sinai Medical Center - 127 San Vicente Blvd | Los Angeles | California | 90048 | Withdrawn |
| Rady Children's Hospital - San Diego - PIN | San Diego | California | 92123 | Not yet recruiting |
| University of California San Francisco | San Francisco | California | 94158 | Withdrawn |
| I.H.S Health LLC-Kissimmee-445 W Oak St | Kissimmee | Florida | 34741 | Withdrawn |
| Childrens Center For Digestive Healthcare | Atlanta | Georgia | 30342 | Not yet recruiting |
| Advocate Children's Hospital - Park Ridge - PIN | Park Ridge | Illinois | 60068 | Recruiting |
| Riley Hospital For Children - PIN | Indianapolis | Indiana | 46202 | Withdrawn |
| Johns Hopkins University | Baltimore | Maryland | 21287 | Withdrawn |
| Boston Children's Hospital - PIN | Boston | Massachusetts | 02215 | Withdrawn |
| MNGI Digestive Health PA-Plymouth | Minneapolis | Minnesota | 55413 | Terminated |
| Mayo Clinic - PIN | Rochester | Minnesota | 55905 | Terminated |
| Goryeb Children's Hospital | Morristown | New Jersey | 07960 | Terminated |
| Cohen Children's Medical Center Northwell - BRANY - PPDS - PIN | New Hyde Park | New York | 11042 | Withdrawn |
| University of Rochester Medical Center - PPDS | Rochester | New York | 14642 | Withdrawn |
| Stony Brook University Medical Center | Stony Brook | New York | 11794 | Withdrawn |
| University Hospitals Cleveland Medical Center - 11100 Euclid Ave | Cleveland | Ohio | 44106 | Not yet recruiting |
| UPMC Children's Hospital of Pittsburgh - Adolescent Medicine (Oakland) - PIN | Pittsburgh | Pennsylvania | 15201 | Withdrawn |
| Hasbro Children's Hospital - PIN | Providence | Rhode Island | 02903 | Withdrawn |
| Texas Children's Hospital - Baylor - PIN | Houston | Texas | 77030 | Not yet recruiting |
| Carilion Children's Tanglewood Center | Roanoke | Virginia | 24018 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 75 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05442567, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 6, 2026 · Synced Sep 5, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05442567 live on ClinicalTrials.gov.