A Study of Vedolizumab in Children and Teenagers With Moderate to Severe Ulcerative Colitis (UC)
Public ClinicalTrials.gov record NCT04779307. 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 Ulcerative Colitis 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 ulcerative colitis will be treated with vedolizumab. The main aim of the study is to check if participants achieve remission after treatment with vedolizumab. Remission means symptoms improve or disappear and an endoscopy shows no or limited signs of disease. The study is also evaluating side effects of vedolizumab in the children and teenager with moderately to severely active ulcerative colitis. Participants will receive 3 infusions of vedolizumab over 6 weeks. Then, those who have a clinical response will receive 1 of 3 doses of vedolizumab once every 8 weeks. They will receive the same dose every time.
Study identification
- NCT ID
- NCT04779307
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 121 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
- Oct 18, 2021
- Primary completion
- Jun 30, 2025
- Completion
- Jun 30, 2025
- Last update posted
- Apr 29, 2026
2021 – 2025
United States locations
- U.S. sites
- 11
- U.S. states
- 10
- U.S. cities
- 11
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Phoenix Childrens Hospital -1919 E Thompson Rd | Phoenix | Arizona | 85016-7710 | — |
| Rady Childrens Hospital San Diego - PIN | San Diego | California | 92123 | — |
| Childrens Center For Digestive Healthcare | Atlanta | Georgia | 30318-4833 | — |
| Advocate Children's Hospital Park Ridge | Park Ridge | Illinois | 60068 | — |
| Boston Children's Hospital | Boston | Massachusetts | 02115 | — |
| MNGI Digestive Health PA-Plymouth | Minneapolis | Minnesota | 55413 | — |
| Mayo Clinic - PIN | Rochester | Minnesota | 55905-0001 | — |
| Goryeb Children's Hospital | Morristown | New Jersey | 07960-6136 | — |
| UPMC Children's Hospital of Pittsburgh-120 Lytton Ave | Pittsburgh | Pennsylvania | 15224-1334 | — |
| Texas Childrens Hospital West Campus | Houston | Texas | 77030-2358 | — |
| Carilion Children's Tanglewood Center | Roanoke | Virginia | 24013-2253 | — |
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 54 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04779307, 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 Apr 29, 2026 · Synced Sep 3, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04779307 live on ClinicalTrials.gov.