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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 is a Phase 3 study that has completed, run by Amgen. The registered enrollment target is 245 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03701763
The ClinicalTrials.gov registry entry for NCT03701763 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 245 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Amgen, which has 558 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03701763 reports 0 study locations.
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.
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