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NCT03123471 · ClinicalTrials.gov registry record · Phase 3
A Study of the Efficacy and Safety of Apremilast (CC-10004) in Subjects With Moderate to Severe Plaque Psoriasis of the Scalp
A Phase 3 study of Psoriasis, sponsored by Amgen.
- Completed
- Registry status
- Phase 3
- Development phase
- 303
- Enrollment target
- 20
- Study locations
NCT03123471: Completed Phase 3 study of Psoriasis, sponsored by Amgen.
NCT03123471 is a Phase 3 study of Psoriasis that has completed, run by Amgen. The registered enrollment target is 303 participants, below the 486-participant average among 125 other Psoriasis trials with a reported enrollment target (38% lower). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03123471, a Phase 3 study of Psoriasis, has completed, sponsored by Amgen.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 303 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a Phase 3, multicenter, randomized, placebo-controlled, double-blind study of the efficacy and safety of apremilast (CC-10004) in subjects with moderate to severe plaque psoriasis of the scalp. Approximately 300 subjects with moderate to severe plaque psoriasis of the scalp will be randomized 2:1 to receive either apremilast 30 mg twice daily (BID) or placebo for the first 16 weeks.
Primary Outcome
The ScPGA is a measurement of overall scalp involvement by the investigator at the time of evaluation. The ScPGA is a 5-point scale ranging from 0 (clear) to 4 (severe), incorporating an assessment of the severity of the 3 primary signs of the disease: erythema, scaling, and plaque elevation. When making the assessment of overall scalp severity, the investigator factored in areas that had already been cleared (ie, had scores of 0), not limited to the evaluation of remaining lesions for severity;
Conditions Studied
Interventions
- OTHER Placebo
- DRUG Apremilast
Study Locations (20)
California
- Tien Q. Nguyen MD Inc - Fountain Valley
- Dermatology Research Associates - Los Angeles
- San Luis Dermatology and Laser Clinic - San Luis Obispo
Florida
- Florida Academic Centers Research and Education - Coral Gables
- International Dermatology Research - Miami
- Renstar Medical Research - Ocala
Georgia
- Dermatologic Surgery Specialists, P.C. - Macon
- MedaPhase INC - Newnan
Kentucky
- DS Research - Louisville
- DS Research - Louisville
New York
- SUNY Downstate Medical Center - Brooklyn
- Forest Hills Dermatology Group - Forest Hills
Arkansas
- Northwest Arkansas Clinical Trials Center, PLLC / Hull Dermatology - Rogers
Connecticut
- University of Connecticut - Farmington
Indiana
- The Indiana Clinical Trials Center, PC - Plainfield
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 303 participants |
| Start Date | 2017-05-16 |
| Est. Completion | 2019-01-09 |
| Phase | Phase 3 |
What the finished NCT03123471 record still lists
NCT03123471 is an interventional study that assigns participants to a tested intervention. The registered 303 participants enrollment target is mid-sized for trials with a published cap, below the 486-participant average among 125 other Psoriasis trials with a reported enrollment target (38% lower).
The record links to 1 condition, with Psoriasis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT03123471 names 20 study sites across 13 states, led by California, Florida, Georgia.
Frequently Asked Questions
What is clinical trial NCT03123471 about?
NCT03123471 is a clinical study titled "A Study of the Efficacy and Safety of Apremilast (CC-10004) in Subjects With Moderate to Severe Plaque Psoriasis of the Scalp". This is a Phase 3, multicenter, randomized, placebo-controlled, double-blind study of the efficacy and safety of apremilast (CC-10004) in subjects with moderate to severe plaque psoriasis of the scalp. Approximately 300 subjects with moderate to severe plaque psoriasis of the scalp will be randomiz...
What is the current status of trial NCT03123471?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 303 participants. The study started on 2017-05-16. Estimated completion is 2019-01-09.
What conditions does trial NCT03123471 study?
This clinical trial studies the following conditions: Psoriasis.
What interventions are being tested in trial NCT03123471?
The interventions under investigation include: Placebo (OTHER), Apremilast (DRUG).
Who is sponsoring clinical trial NCT03123471?
This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03123471 being conducted?
This trial has 20 study locations across Arkansas, California, Connecticut, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Psoriasis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03123471's enrollment target sits among peer trials
303 26th of 125 higher than 100 of 125 other Psoriasis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Psoriasis 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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