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NCT04673357 · ClinicalTrials.gov registry record · Phase 3
A Study of Ustekinumab in Pediatric Participants With Moderately to Severely Active Crohn's Disease
A Phase 3 study, sponsored by Janssen Research & Development.
- Completed
- Registry status
- Phase 3
- Development phase
- 101
- Enrollment target
NCT04673357 is a Phase 3 study that has completed, run by Janssen Research & Development. The registered enrollment target is 101 participants.
The verdict
NCT04673357, a Phase 3 study, has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 101 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the efficacy of ustekinumab dosing in inducing clinical remission (Global) and in maintaining clinical remission (US); to evaluate the safety profile and ustekinumab exposure (pharmacokinetics \[PK\]) in pediatric participants with moderately to severely active Crohn's disease.
Interventions
- DRUG Placebo
- DRUG Ustekinumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 101 participants |
| Start Date | 2021-04-06 |
| Est. Completion | 2025-03-03 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04673357
The ClinicalTrials.gov registry entry for NCT04673357 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 101 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 Placebo is the first listed.
NCT04673357 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04673357 about?
NCT04673357 is a clinical study titled "A Study of Ustekinumab in Pediatric Participants With Moderately to Severely Active Crohn's Disease". The purpose of this study is to evaluate the efficacy of ustekinumab dosing in inducing clinical remission (Global) and in maintaining clinical remission (US); to evaluate the safety profile and ustekinumab exposure (pharmacokinetics \[PK\]) in pediatric participants with moderately to severely acti...
What is the current status of trial NCT04673357?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 101 participants. The study started on 2021-04-06. Estimated completion is 2025-03-03.
What interventions are being tested in trial NCT04673357?
The interventions under investigation include: Placebo (DRUG), Ustekinumab (DRUG).
Who is sponsoring clinical trial NCT04673357?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
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