A Long-Term Extension Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis (UC) or Crohn's Disease (CD)
Public ClinicalTrials.gov record NCT06405087. 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 Phase 3b Extension Study to Evaluate the Long-term Safety of Vedolizumab Subcutaneous in Pediatric Subjects With Ulcerative Colitis or Crohn's Disease
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The main aim of this study is to learn about medical problems (adverse events) if vedolizumab subcutaneously (SC) is given to a child or teenager with UC or CD for a long time. Other aims are to understand if the long time use of vedolizumab SC has an impact on the time period until hospital visits because of bowel swelling (inflammation) are needed and has an impact on the quality of life of children and teenagers who received vedolizumab SC. In this study, participants who responded well to the treatment with vedolizumab SC in the parent study (VedolizumabSC-3003 \[NCT06100289\]) will continue to be treated with vedolizumab SC. Participants who did not respond well to the treatment with vedolizumab SC in the parent study or who received corticosteroids in the last 4 weeks of the parent study will not receive vedolizumab SC in this study but will be followed for up to 2 years after the last treatment with vedolizumab SC in the parent study. During the study, participants will visit their study clinic several times.
Study identification
- NCT ID
- NCT06405087
- 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
- Oct 26, 2025
- Primary completion
- Aug 11, 2030
- Completion
- Aug 11, 2030
- Last update posted
- Jun 21, 2026
2025 – 2030
United States locations
- U.S. sites
- 14
- U.S. states
- 11
- U.S. cities
- 13
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Phoenix Childrens Hospital | Phoenix | Arizona | 85016 | Not yet recruiting |
| Loma Linda University | Loma Linda | California | 92350 | Not yet recruiting |
| Children's Hospital of Orange County | Orange | California | 92868 | Not yet recruiting |
| Stanford Children's Health | Palo Alto | California | 94304 | Not yet recruiting |
| Advocate Children's Hospital Park Ridge | Park Ridge | Illinois | 60068 | Not yet recruiting |
| Childrens Hospital of Michigan | Detroit | Michigan | 48201 | Not yet recruiting |
| Atlantic Health - Morristown Medical Center | Morristown | New Jersey | 07960 | Not yet recruiting |
| New York Presbyterian Hospital | New York | New York | 10029 | Not yet recruiting |
| University Children's Clinic | Cleveland | Ohio | 44106 | Not yet recruiting |
| Cleveland Clinic | Cleveland | Ohio | 44195 | Not yet recruiting |
| The University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73104 | Recruiting |
| Penn State Health Milton South Hershey Medical Center | Hershey | Pennsylvania | 17033 | Not yet recruiting |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | Not yet recruiting |
| Multicare Health System Institute for Research and 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 NCT06405087, 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 Jun 21, 2026 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06405087 live on ClinicalTrials.gov.