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NCT06100289 · ClinicalTrials.gov registry record · Phase 3
A Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis or Crohn's Disease
A Phase 3 study of Ulcerative Colitis and Crohn's Disease, sponsored by Takeda.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 70
- Enrollment target
- 20
- Study locations
NCT06100289: Recruiting Phase 3 study of Ulcerative Colitis and Crohn's Disease, sponsored by Takeda.
NCT06100289 is a Phase 3 study of Ulcerative Colitis and Crohn's Disease that is actively recruiting participants, run by Takeda. The registered enrollment target is 70 participants, below the 2,057-participant average among 122 other Ulcerative Colitis trials with a reported enrollment target (97% lower). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06100289, a Phase 3 study of Ulcerative Colitis and Crohn's Disease, is actively recruiting participants, sponsored by Takeda.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 70 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Conditions Studied
Interventions
- DRUG Vedolizumab IV
- DRUG Vedolizumab SC
Study Locations (20)
Other
- Cliniques Universitaires Saint-Luc - Brussels
- Centre Hospitalier Chretien MontLegia - Liège
- University Hospital "Saint George" - Plovdiv
- Specialized Hospital for Active Treatment of Children Diseases "Prof. Dr. Ivan Mitev" EAD - Sofia
- H.C Andersens Hospital - Odense
- Childrens Health Ireland - Dublin
- Azienda Ospedaliera Universitaria Gaetano Martino Messina - Messina
- V. Buzzi Hospital - Milan
California
- VVCRD Clinical Research - Garden Grove
- Loma Linda University School of Medicine - Loma Linda
- Children's Hospital Of Orange County - Orange
- Stanford Children's Health - Palo Alto
Illinois
- Advocate Children's Hospital - Park Ridge
Michigan
- Children's Hospital of Michigan - Detroit
New Jersey
- Atlantic Health System - Morristown
New York
- New York Presbyterian Hospital, Weill Cornell Medical College - New York
Ohio
- Cleveland Clinic Foundation - Cleveland
Oklahoma
- The University of Oklahoma Health Sciences Center - Oklahoma City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2025-01-22 |
| Est. Completion | 2027-06-30 |
| Phase | Phase 3 |
What NCT06100289 shows while recruiting
NCT06100289 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 70 participants, a relatively small participant target, below the 2,057-participant average among 122 other Ulcerative Colitis trials with a reported enrollment target (97% lower).
The record links to 2 conditions, with Ulcerative Colitis appearing as the primary indexed condition, and to 2 interventions - of which Vedolizumab IV is the first listed.
NCT06100289 names 20 study sites across 10 states, led by Other, California, Illinois.
Frequently Asked Questions
What is clinical trial NCT06100289 about?
NCT06100289 is a clinical study titled "A Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis or Crohn's Disease". 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...
What is the current status of trial NCT06100289?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 70 participants. The study started on 2025-01-22. Estimated completion is 2027-06-30.
What conditions does trial NCT06100289 study?
This clinical trial studies the following conditions: Ulcerative Colitis, Crohn's Disease.
What interventions are being tested in trial NCT06100289?
The interventions under investigation include: Vedolizumab IV (DRUG), Vedolizumab SC (DRUG).
Who is sponsoring clinical trial NCT06100289?
This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06100289 being conducted?
This trial has 20 study locations across California, Illinois, Michigan, New Jersey, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06100289's enrollment target sits among peer trials
70 72nd of 122 higher than 49 of 122 other Ulcerative Colitis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Ulcerative Colitis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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