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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: Completed Phase 3 study, sponsored by Amgen.
NCT03777436 is a Phase 3 study that has completed, run by Amgen. The registered enrollment target is 289 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (63% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The modified sPGA-G is the assessment by the Investigator of the participant's psoriasis lesions' overall disease severity in the genital area at the time of evaluation. The modified sPGA-G is a 5-point scale ranging from clear (0), almost clear (1), mild (2), moderate (3), to severe (4), incorporating an assessment of the severity of the 3 primary signs of the disease: erythema, plaque elevation, and scaling. A modified sPGA-G response is defined as modified sPGA-G score of clear (0) or almost
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 |
What the finished NCT03777436 record still lists
NCT03777436 is an interventional study that assigns participants to a tested intervention. The registered 289 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 (63% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03777436 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03777436's enrollment target sits among peer trials
289 1173rd of 2000 higher than 827 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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