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Recruiting Phase 3 Interventional

A Study of Vedolizumab in Children and Teenagers With Moderate to Severe Crohn's Disease (CD)

ClinicalTrials.gov ID: NCT04779320

Public ClinicalTrials.gov record NCT04779320. 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.

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ClinicalTrials.gov public records Last synced May 6, 2026, 8:11 PM 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 Randomized, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of Vedolizumab Intravenous as Maintenance Therapy in Pediatric Subjects With Moderately to Severely Active Crohn's Disease Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy

Study identification

NCT ID
NCT04779320
Recruitment status
Recruiting
Study type
Interventional
Phase
Phase 3
Lead sponsor
Takeda
Industry
Enrollment
120 participants

Conditions and interventions

Interventions

  • Vedolizumab IV Drug

Drug

Eligibility (public fields only)

Age range
2 Years to 17 Years
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
Feb 9, 2022
Primary completion
Sep 12, 2027
Completion
Sep 12, 2027
Last update posted
May 4, 2026

2022 – 2027

United States locations

U.S. sites
22
U.S. states
16
U.S. cities
22
Facility City State ZIP Site status
Phoenix Childrens Hospital Phoenix Arizona 85016 Not yet recruiting
Cedars Sinai Medical Center Los Angeles California 90048 Withdrawn
Rady Childrens Hospital San Diego - PIN San Diego California 92123 Not yet recruiting
University of California San Francisco San Francisco California 94143 Withdrawn
I.H.S Health LLC Kissimmee Florida 34741 Withdrawn
Childrens Center For Digestive Healthcare Atlanta Georgia 30342 Recruiting
Advocate Children's Hospital Park Ridge Park Ridge Illinois 60068 Recruiting
Riley Hospital For Children Indianapolis Indiana 46202 Withdrawn
Johns Hopkins University Baltimore Maryland 21287 Not yet recruiting
Boston Children's Hospital Boston Massachusetts 02115 Not yet recruiting
MNGI Digestive Health, PA Minneapolis Minnesota 55413 Recruiting
Mayo Clinic - PIN Rochester Minnesota 55905 Not yet recruiting
Goryeb Children's Hospital Morristown New Jersey 07960 Recruiting
The Steven and Alexandra Cohen Childrens Medical Center of New York - BRANY - PPDS New Hyde Park New York 11042 Recruiting
University of Rochester Medical Center PPDS Rochester New York 14642 Withdrawn
Stony Brook University Medical Center Stony Brook New York 11794 Recruiting
SUNY Upstate Medical Center Syracuse New York 13202 Withdrawn
University Hospitals Cleveland Medical Center Cleveland Ohio 44106 Not yet recruiting
Children's Hospital of Pittsburgh Pittsburgh Pennsylvania 15201 Not yet recruiting
Hasbro Children's Hospital Providence Rhode Island 02903 Withdrawn
Texas Children's Hospital Houston Texas 77030 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 73 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04779320, 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 4, 2026 · Synced May 6, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT04779320 live on ClinicalTrials.gov.

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