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NCT05442567 · ClinicalTrials.gov registry record · Phase 3
A Study of Vedolizumab in Children With Ulcerative Colitis (UC) or Crohn's Disease (CD)
A Phase 3 study of Ulcerative Colitis and Crohn's Disease, sponsored by Takeda.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 240
- Enrollment target
- 20
- Study locations
NCT05442567: Recruiting Phase 3 study of Ulcerative Colitis and Crohn's Disease, sponsored by Takeda.
NCT05442567 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 240 participants, below the 2,055-participant average among 122 other Ulcerative Colitis trials with a reported enrollment target (88% lower). The trial reports 20 study locations across 18 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05442567, 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
- 240 participants
- Enrollment target
- 20
- Study locations
Study Summary
The study is an extension of two parent studies (MLN0002-3024 \[NCT04779307\] and MLN0002-3025 \[NCT04779320\]). Participants must have participated in one of the previous studies. The purpose of this study is to collect the long-term safety of vedolizumab in children with UC or CD.
Primary Outcome
An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have causal relationship with this treatment. AE can be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a drug whether or not it is considered related to drug.
Conditions Studied
Interventions
- OTHER No Intervention
- DRUG Vedolizumab IV
Study Locations (20)
Minnesota
- MNGI Digestive Health PA-Plymouth - Minneapolis
- Mayo Clinic - PIN - Rochester
Victoria
- Monash Health, Monash Medical Centre - Clayton
- Royal Children's Hospital Melbourne - PIN - Parkville
Arizona
- Phoenix Childrens Hospital -1919 E Thompson Rd - Phoenix
California
- Rady Childrens Hospital San Diego - PIN - San Diego
Georgia
- Childrens Center For Digestive Healthcare - Atlanta
Illinois
- Advocate Children's Hospital Park Ridge - Park Ridge
Maryland
- Johns Hopkins University - Baltimore
Massachusetts
- Boston Children's Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 240 participants |
| Start Date | 2023-05-16 |
| Est. Completion | 2031-08-15 |
| Phase | Phase 3 |
What NCT05442567 shows while recruiting
NCT05442567 is an interventional study that assigns participants to a tested intervention. The registered 240 participants enrollment target is mid-sized for trials with a published cap, below the 2,055-participant average among 122 other Ulcerative Colitis trials with a reported enrollment target (88% lower).
The record links to 2 conditions, with Ulcerative Colitis appearing as the primary indexed condition, and to 2 interventions - of which No Intervention is the first listed.
NCT05442567 names 20 study sites across 18 states, led by Minnesota, Victoria, Arizona.
Frequently Asked Questions
What is clinical trial NCT05442567 about?
NCT05442567 is a clinical study titled "A Study of Vedolizumab in Children With Ulcerative Colitis (UC) or Crohn's Disease (CD)". The study is an extension of two parent studies (MLN0002-3024 \[NCT04779307\] and MLN0002-3025 \[NCT04779320\]). Participants must have participated in one of the previous studies. The purpose of this study is to collect the long-term safety of vedolizumab in children with UC or CD.
What is the current status of trial NCT05442567?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 240 participants. The study started on 2023-05-16. Estimated completion is 2031-08-15.
What conditions does trial NCT05442567 study?
This clinical trial studies the following conditions: Ulcerative Colitis, Crohn's Disease.
What interventions are being tested in trial NCT05442567?
The interventions under investigation include: No Intervention (OTHER), Vedolizumab IV (DRUG).
Who is sponsoring clinical trial NCT05442567?
This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05442567 being conducted?
This trial has 20 study locations across Arizona, California, Georgia, Illinois, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Ulcerative Colitis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05442567's enrollment target sits among peer trials
240 39th of 122 higher than 84 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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