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NCT04779307 · ClinicalTrials.gov registry record · Phase 3
A Study of Vedolizumab in Children and Teenagers With Moderate to Severe Ulcerative Colitis (UC)
A Phase 3 study, sponsored by Takeda.
- Completed
- Registry status
- Phase 3
- Development phase
- 121
- Enrollment target
NCT04779307: Completed Phase 3 study, sponsored by Takeda.
NCT04779307 is a Phase 3 study that has completed, run by Takeda. The registered enrollment target is 121 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (84% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04779307, a Phase 3 study, has completed, sponsored by Takeda.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 121 participants
- Enrollment target
Study Summary
Vedolizumab is a medicine that helps to reduce inflammation and pain in the digestive system. In this study, children and teenagers with moderate to severe ulcerative colitis will be treated with vedolizumab. The main aim of the study is to check if participants achieve remission after treatment with vedolizumab. Remission means symptoms improve or disappear and an endoscopy shows no or limited signs of disease. The study is also evaluating side effects of vedolizumab in the children and teenager with moderately to severely active ulcerative colitis. Participants will receive 3 infusions of vedolizumab over 6 weeks. Then, those who have a clinical response will receive 1 of 3 doses of vedolizumab once every 8 weeks. They will receive the same dose every time.
Primary Outcome
Clinical remission based on the modified Mayo score was defined as stool frequency sub score 0 to 1 and a decrease of 1 or more from baseline, rectal bleeding sub score of 0, and endoscopy sub score 0 to 1 (modified so that a score of 1 does not include friability) and without presence of any intercurrent event. Mayo score was an instrument designed to measure disease activity of UC. Modified Mayo score was a composite index of 3 disease activity variables (stool frequency, rectal bleeding, and
Interventions
- DRUG Vedolizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 121 participants |
| Start Date | 2021-10-19 |
| Est. Completion | 2025-07-01 |
| Phase | Phase 3 |
What the finished NCT04779307 record still lists
NCT04779307 is an interventional study that assigns participants to a tested intervention. The registered 121 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (84% lower).
The record links to 0 conditions, and to 1 intervention - of which Vedolizumab is the first listed.
NCT04779307 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04779307 about?
NCT04779307 is a clinical study titled "A Study of Vedolizumab in Children and Teenagers With Moderate to Severe Ulcerative Colitis (UC)". Vedolizumab is a medicine that helps to reduce inflammation and pain in the digestive system. In this study, children and teenagers with moderate to severe ulcerative colitis will be treated with vedolizumab. The main aim of the study is to check if participants achieve remission after treatment wi...
What is the current status of trial NCT04779307?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 121 participants. The study started on 2021-10-19. Estimated completion is 2025-07-01.
What interventions are being tested in trial NCT04779307?
The interventions under investigation include: Vedolizumab (DRUG).
Who is sponsoring clinical trial NCT04779307?
This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04779307's enrollment target sits among peer trials
121 1619th of 2000 higher than 382 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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