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NCT04630028 · ClinicalTrials.gov registry record · Phase 3
A Study of Ustekinumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis (UC)
A Phase 3 study, sponsored by Janssen Research & Development.
- Completed
- Registry status
- Phase 3
- Development phase
- 112
- Enrollment target
NCT04630028 is a Phase 3 study that has completed, run by Janssen Research & Development. The registered enrollment target is 112 participants.
The verdict
NCT04630028, a Phase 3 study, has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 112 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate: a) the efficacy of ustekinumab dosing in inducing clinical remission, b) safety profile of ustekinumab, and c) ustekinumab exposure (pharmacokinetics \[PK\]) in pediatric participants with moderately to severely active UC.
Interventions
- DRUG Matching Placebo
- DRUG Ustekinumab Dose Based on BSA and Body Weight
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 112 participants |
| Start Date | 2021-03-17 |
| Est. Completion | 2025-06-05 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04630028
The ClinicalTrials.gov registry entry for NCT04630028 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 112 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Janssen Research & Development, which has 593 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Matching Placebo is the first listed.
NCT04630028 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04630028 about?
NCT04630028 is a clinical study titled "A Study of Ustekinumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis (UC)". The purpose of this study is to evaluate: a) the efficacy of ustekinumab dosing in inducing clinical remission, b) safety profile of ustekinumab, and c) ustekinumab exposure (pharmacokinetics \[PK\]) in pediatric participants with moderately to severely active UC.
What is the current status of trial NCT04630028?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 112 participants. The study started on 2021-03-17. Estimated completion is 2025-06-05.
What interventions are being tested in trial NCT04630028?
The interventions under investigation include: Matching Placebo (DRUG), Ustekinumab Dose Based on BSA and Body Weight (DRUG).
Who is sponsoring clinical trial NCT04630028?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
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