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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: Completed Phase 3 study, sponsored by Janssen Research & Development.
NCT04630028 is a Phase 3 study that has completed, run by Janssen Research & Development. The registered enrollment target is 112 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Clinical remission is defined as Mayo stool frequency subscore of 0 or 1, a rectal bleeding subscore of 0, and an endoscopy subscore of 0 or 1 with no friability present on the endoscopy, where the stool frequency subscore has not increased from induction baseline.
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 |
What the finished NCT04630028 record still lists
NCT04630028 is an interventional study that assigns participants to a tested intervention. The registered 112 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 (85% lower).
The record links to 0 conditions, and to 2 interventions - of which Matching Placebo is the first listed.
NCT04630028 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04630028's enrollment target sits among peer trials
112 1652nd of 2000 higher than 346 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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