A Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis or Crohn's Disease

ClinicalTrials.gov ID: NCT06100289

Public ClinicalTrials.gov record NCT06100289. 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, 8:44 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

An Open-Label, Phase 3 Study to Evaluate the Pharmacokinetics, Safety, and Immunogenicity of Vedolizumab Subcutaneous in Pediatric Subjects With Moderately to Severely Active Ulcerative Colitis or Crohn's Disease Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy

Study identification

NCT ID: NCT06100289
Recruitment status: Recruiting
Study type: Interventional
Phase: Phase 3
Lead sponsor: Takeda; Industry
Enrollment: 70 participants

Conditions and interventions

Conditions

Interventions

Vedolizumab IV Drug
Vedolizumab SC 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: Jan 21, 2025
Primary completion: Nov 14, 2027
Completion: Nov 14, 2027
Last update posted: May 5, 2026

2025 – 2027

United States locations

U.S. sites: 11
U.S. states: 8
U.S. cities: 11

Facility	City	State	ZIP	Site status
VVCRD Clinical Research	Garden Grove	California	92845-2006	Terminated
Loma Linda University School of Medicine	Loma Linda	California	92354	Active, not recruiting
Children's Hospital Of Orange County	Orange	California	92868	Active, not recruiting
Stanford Children's Health	Palo Alto	California	94304	Active, not recruiting
Advocate Children's Hospital	Park Ridge	Illinois	60068	Active, not recruiting
Children's Hospital of Michigan	Detroit	Michigan	48201	Recruiting
Atlantic Health System	Morristown	New Jersey	07960	Active, not recruiting
New York Presbyterian Hospital, Weill Cornell Medical College	New York	New York	10065	Active, not recruiting
Cleveland Clinic Foundation	Cleveland	Ohio	44195	Active, not recruiting
The University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma	73104	Active, not recruiting
Medical University of South Carolina	North Charleston	South Carolina	29406	Active, not 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 46 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT06100289, 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 5, 2026 · Synced May 6, 2026

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The complete protocol, eligibility criteria, and contact information for NCT06100289 live on ClinicalTrials.gov.

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