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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05442567
The ClinicalTrials.gov registry entry for NCT05442567 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 240 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,055-participant average among 122 other Ulcerative Colitis trials with a reported enrollment target (88% lower). The listed sponsor is Takeda, which has 408 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 18 distinct geographic areas - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.