A Study of Vedolizumab in Children and Teenagers With Moderate to Severe Crohn's Disease (CD)
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.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Vedolizumab is a medicine that helps to reduce inflammation and pain in the digestive system. In this study, children and teenagers with moderate to severe Crohn's disease will be treated with vedolizumab. The main aim of the study is to check if participants achieve remission after treatment with the vedolizumab. Remission means symptoms improve or disappear and an endoscopy shows no signs of inflammation. Participants will receive 3 infusions of vedolizumab over 6 weeks. Then, those who have a clinical response will receive either a high dose or low dose of vedolizumab once every 8 weeks. They will receive the same dose every time.
Study identification
- NCT ID
- NCT04779320
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 120 participants
Conditions and interventions
Conditions
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| Cedars Sinai Medical Center | Los Angeles | California | 90048 | Withdrawn |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 Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04779320 live on ClinicalTrials.gov.