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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 is a Phase 3 study that is actively recruiting participants, run by Takeda. The registered enrollment target is 70 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06405087
The ClinicalTrials.gov registry entry for NCT06405087 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 70 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Takeda, which has 408 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which No Intervention is the first listed.
NCT06405087 reports 0 study locations.
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.
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