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NCT03701763 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety Study of Apremilast (CC-10004) in Pediatric Subjects From 6 Through 17 Years of Age With Moderate to Severe Plaque Psoriasis
A Phase 3 study, sponsored by Amgen.
- Completed
- Registry status
- Phase 3
- Development phase
- 245
- Enrollment target
NCT03701763: Completed Phase 3 study, sponsored by Amgen.
NCT03701763 is a Phase 3 study that has completed, run by Amgen. The registered enrollment target is 245 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (68% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03701763, a Phase 3 study, has completed, sponsored by Amgen.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 245 participants
- Enrollment target
Study Summary
This is a Phase 3, multicenter, randomized, placebo-controlled, double-blind study of the efficacy and safety of apremilast (CC-10004) in pediatric subjects with moderate to severe plaque psoriasis. At least 230 pediatric subjects (ages 6 through 17 years) will be randomized 2:1 to receive either apremilast or placebo for the first 16 weeks and then all subjects will receive apremilast during the 36 week Extension Phase for a total of 52 weeks. Randomization to apremilast arm or placebo arm will be stratified by age group (6 to 11 years or 12 to 17 years). Subjects will receive apremilast treatment of either 20 mg twice daily (BID) or 30 mg BID, depending on weight. This Phase 3 study is being conducted to evaluate the safety and efficacy of apremilast in the treatment of pediatric subjects.
Primary Outcome
The sPGA is the assessment by the Investigator of the overall disease severity of plaque psoriasis at the time of evaluation. The sPGA is a 5-point scale ranging from 0 (clear) to 4 (severe), incorporating an assessment of the severity of the three primary signs of the disease: erythema, scaling and plaque elevation. The results presented are for the percentage of participants with a sPGA response. An sPGA response was defined as a score of clear (0) or almost clear (1) with at least a 2-point r
Interventions
- OTHER Placebo
- DRUG Apremilast (CC-10004)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 245 participants |
| Start Date | 2018-12-19 |
| Est. Completion | 2023-03-27 |
| Phase | Phase 3 |
What the finished NCT03701763 record still lists
NCT03701763 is an interventional study that assigns participants to a tested intervention. The registered 245 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 (68% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03701763 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03701763 about?
NCT03701763 is a clinical study titled "Efficacy and Safety Study of Apremilast (CC-10004) in Pediatric Subjects From 6 Through 17 Years of Age With Moderate to Severe Plaque Psoriasis". This is a Phase 3, multicenter, randomized, placebo-controlled, double-blind study of the efficacy and safety of apremilast (CC-10004) in pediatric subjects with moderate to severe plaque psoriasis. At least 230 pediatric subjects (ages 6 through 17 years) will be randomized 2:1 to receive either a...
What is the current status of trial NCT03701763?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 245 participants. The study started on 2018-12-19. Estimated completion is 2023-03-27.
What interventions are being tested in trial NCT03701763?
The interventions under investigation include: Placebo (OTHER), Apremilast (CC-10004) (DRUG).
Who is sponsoring clinical trial NCT03701763?
This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03701763's enrollment target sits among peer trials
245 1267th of 2000 higher than 732 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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