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NCT06405087 · ClinicalTrials.gov registry record · Phase 3
A Long-Term Extension Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis (UC) or Crohn's Disease (CD)
A Phase 3 study, sponsored by Takeda.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 70
- Enrollment target
NCT06405087: Recruiting Phase 3 study, sponsored by Takeda.
NCT06405087 is a Phase 3 study that is actively recruiting participants, run by Takeda. The registered enrollment target is 70 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06405087, a Phase 3 study, is actively recruiting participants, sponsored by Takeda.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 70 participants
- Enrollment target
Study Summary
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.
Primary Outcome
An Adverse event (AE) is defined as any untoward medical occurrence in clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory value), symptom, or disease temporally associated with use of drug whether or not it is considered related to drug. SAE is defined as any untoward medical occurrence that at any dose
Interventions
- OTHER No Intervention
- DRUG Vedolizumab SC
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2025-10-27 |
| Est. Completion | 2030-08-12 |
| Phase | Phase 3 |
What NCT06405087 shows while recruiting
NCT06405087 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 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (91% lower).
The record links to 0 conditions, and to 2 interventions - of which No Intervention is the first listed.
NCT06405087 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06405087 about?
NCT06405087 is a clinical study titled "A Long-Term Extension Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis (UC) or Crohn's Disease (CD)". 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 ...
What is the current status of trial NCT06405087?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 70 participants. The study started on 2025-10-27. Estimated completion is 2030-08-12.
What interventions are being tested in trial NCT06405087?
The interventions under investigation include: No Intervention (OTHER), Vedolizumab SC (DRUG).
Who is sponsoring clinical trial NCT06405087?
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 NCT06405087's enrollment target sits among peer trials
70 1785th of 2000 higher than 208 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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