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NCT03777436 · ClinicalTrials.gov registry record · Phase 3
An Efficacy and Safety Study of Apremilast (CC-10004) in Subjects With Moderate to Severe Genital Psoriasis
A Phase 3 study, sponsored by Amgen.
- Completed
- Registry status
- Phase 3
- Development phase
- 289
- Enrollment target
NCT03777436 is a Phase 3 study that has completed, run by Amgen. The registered enrollment target is 289 participants.
The verdict
NCT03777436, a Phase 3 study, has completed, sponsored by Amgen.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 289 participants
- Enrollment target
Study Summary
This Phase 3 multicenter, randomized, placebo-controlled, double-blind study is designed to evaluate the efficacy and safety of apremilast in subjects with moderate to severe genital psoriasis (modified sPGA-G ≥3, moderate or severe). Approximately 286 subjects with moderate to severe genital psoriasis will be randomized 1:1 to receive either apremilast 30 mg BID or placebo for the first 16 weeks.
Interventions
- OTHER Placebo
- DRUG Apremilast
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 289 participants |
| Start Date | 2019-02-11 |
| Est. Completion | 2022-02-09 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03777436
The ClinicalTrials.gov registry entry for NCT03777436 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 289 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.
NCT03777436 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03777436 about?
NCT03777436 is a clinical study titled "An Efficacy and Safety Study of Apremilast (CC-10004) in Subjects With Moderate to Severe Genital Psoriasis". This Phase 3 multicenter, randomized, placebo-controlled, double-blind study is designed to evaluate the efficacy and safety of apremilast in subjects with moderate to severe genital psoriasis (modified sPGA-G ≥3, moderate or severe). Approximately 286 subjects with moderate to severe genital psori...
What is the current status of trial NCT03777436?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 289 participants. The study started on 2019-02-11. Estimated completion is 2022-02-09.
What interventions are being tested in trial NCT03777436?
The interventions under investigation include: Placebo (OTHER), Apremilast (DRUG).
Who is sponsoring clinical trial NCT03777436?
This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.
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