A Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis or Crohn's Disease
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.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The main aim of this study is to learn how the body of a child or teenager with moderately to severely active ulcerative colitis (UC) or Crohn's disease (CD) processes vedolizumab (pharmacokinetics) given just under the skin subcutaneously (SC). The participants will be treated with vedolizumab for up to 34 weeks. During the study, participants will visit their study clinic several times.
Study identification
- NCT ID
- NCT06100289
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 70 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
- Jan 21, 2025
- Primary completion
- May 15, 2028
- Completion
- May 15, 2028
- Last update posted
- Aug 2, 2026
2025 – 2028
United States locations
- U.S. sites
- 14
- U.S. states
- 11
- U.S. cities
- 13
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Phoenix Children's Hospital | Phoenix | Arizona | 85016 | Not yet recruiting |
| Loma Linda University School of Medicine | Loma Linda | California | 92354 | Active, not recruiting |
| Children's Hospital Of Orange County | Orange | California | 92868 | 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 |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | Active, not recruiting |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | Active, not recruiting |
| The University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73104 | Recruiting |
| Penn State Health Milton S. Hershey Medical Center/ Penn State University College of Medicine | Hershey | Pennsylvania | 17033 | Active, not recruiting |
| Medical University of South Carolina | North Charleston | South Carolina | 29406 | Not yet recruiting |
| MultiCare Institute for Research & Innovation | Tacoma | Washington | 98405 | Not yet 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 40 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 Aug 2, 2026 · Synced Sep 1, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06100289 live on ClinicalTrials.gov.