ClinicalTrials.gov record
Recruiting Phase 3 Interventional

A Study of Vedolizumab in Children With Ulcerative Colitis (UC) or Crohn's Disease (CD)

ClinicalTrials.gov ID: NCT05442567

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.

ClinicalTrials.gov public records Last synced May 8, 2026, 8:09 AM EDT

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

Study identification

NCT ID
NCT05442567
Recruitment status
Recruiting
Study type
Interventional
Phase
Phase 3
Lead sponsor
Takeda
Industry
Enrollment
240 participants

Conditions and interventions

Interventions

  • No Intervention Other
  • Vedolizumab IV Drug

Other · Drug

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Cedars Sinai Medical Center - 127 San Vicente Blvd Los Angeles California 90048 Withdrawn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University of California San Francisco San Francisco California 94158 Withdrawn
I.H.S Health LLC-Kissimmee-445 W Oak St Kissimmee Florida 34741 Withdrawn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Riley Hospital For Children - PIN Indianapolis Indiana 46202 Withdrawn
Johns Hopkins University Baltimore Maryland 21287 Withdrawn
Boston Children's Hospital - PIN Boston Massachusetts 02215 Withdrawn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 May 8, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT05442567 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →