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NCT02698475 · ClinicalTrials.gov registry record · Phase 3
An Efficacy, Safety, and Pharmacokinetics Study of Subcutaneously Administered Ustekinumab in the Treatment of Moderate to Severe Chronic Plaque Psoriasis in Pediatric Participants Greater Than or Equal to 6 to Less Than 12 Years of Age
A Phase 3 study, sponsored by Janssen Research & Development.
- Completed
- Registry status
- Phase 3
- Development phase
- 44
- Enrollment target
NCT02698475: Completed Phase 3 study, sponsored by Janssen Research & Development.
NCT02698475 is a Phase 3 study that has completed, run by Janssen Research & Development. The registered enrollment target is 44 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02698475, a Phase 3 study, has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 44 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the efficacy and safety of ustekinumab in pediatric participants aged greater than or equal to (\>=) 6 through less than (\<) 12 years with moderate to severe chronic plaque psoriasis
Primary Outcome
The PGA is used to determine the participant's psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participant's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), marked (4), or severe (5). Higher scores indicate worse disease. Treatment Failure (TF) criteria- discontinued study agent due to lack of efficacy or adverse event of psoriasis or who started protocol-prohibited medication/therapy.
Interventions
- DRUG Ustekinumab 45 mg
- DRUG Ustekinumab 90 mg
- DRUG Ustekinumab 0.75 mg/kg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2016-05 |
| Est. Completion | 2020-10 |
| Phase | Phase 3 |
What the finished NCT02698475 record still lists
NCT02698475 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 44 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 3 interventions - of which Ustekinumab 45 mg is the first listed.
NCT02698475 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02698475 about?
NCT02698475 is a clinical study titled "An Efficacy, Safety, and Pharmacokinetics Study of Subcutaneously Administered Ustekinumab in the Treatment of Moderate to Severe Chronic Plaque Psoriasis in Pediatric Participants Greater Than or Equal to 6 to Less Than 12 Years of Age". The purpose of this study is to evaluate the efficacy and safety of ustekinumab in pediatric participants aged greater than or equal to (\>=) 6 through less than (\<) 12 years with moderate to severe chronic plaque psoriasis
What is the current status of trial NCT02698475?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 44 participants. The study started on 2016-05. Estimated completion is 2020-10.
What interventions are being tested in trial NCT02698475?
The interventions under investigation include: Ustekinumab 45 mg (DRUG), Ustekinumab 90 mg (DRUG), Ustekinumab 0.75 mg/kg (DRUG).
Who is sponsoring clinical trial NCT02698475?
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 NCT02698475's enrollment target sits among peer trials
44 1874th of 2000 higher than 125 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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