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NCT01690299 · ClinicalTrials.gov registry record · Phase 3
Phase 3b Safety and Efficacy Study of Apremilast to Treat Moderate to Severe Plaque-plaque Psoriasis
A Phase 3 study of Psoriasis and Psoriatic Arthritis, sponsored by Amgen.
- Completed
- Registry status
- Phase 3
- Development phase
- 250
- Enrollment target
- 20
- Study locations
NCT01690299: Completed Phase 3 study of Psoriasis and Psoriatic Arthritis, sponsored by Amgen.
NCT01690299 is a Phase 3 study of Psoriasis and Psoriatic Arthritis that has completed, run by Amgen. The registered enrollment target is 250 participants, below the 487-participant average among 125 other Psoriasis trials with a reported enrollment target (49% lower). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01690299, a Phase 3 study of Psoriasis and Psoriatic Arthritis, has completed, sponsored by Amgen.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 250 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study will test the clinical effectiveness and safety of apremilast compared with placebo as well as etanercept compared with placebo in the same group of patients with moderate to severe plaque psoriasis.
Primary Outcome
PASI-75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score at Week 16. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater dise
Conditions Studied
Interventions
- DRUG Apremilast
- DRUG Placebo tablet
- DRUG Etanercept
- DRUG Placebo injection
Study Locations (20)
Florida
- Florida Center for Dermatology, PA - Jacksonville
- Florida Academic Dermatology Center - Miami
- International Dermatology Research - Miami
- Renstar Medical Research - Ocala
California
- Bakersfield Dermatology and Skin Cancer Medical Group - Bakersfield
- University of California Irvine-Department of Dermatology - Irvine
- University of California San Diego Medical Center - San Diego
Illinois
- NorthShore University HealthSystem - Skokie
- Southern Illinois University School of Medicine - Springfield
New York
- Forest Hills Dermatology Group - Forest Hills
- NYU Department of Dermatology - New York
Arizona
- Arizona Research Center - Phoenix
Colorado
- Horizons Clinical Research - Denver
District of Columbia
- George Washington University - Washington D.C.
Georgia
- Atlanta Dermatology, Vein and Research Center, PC - Alpharetta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 250 participants |
| Start Date | 2012-10-01 |
| Est. Completion | 2016-04-04 |
| Phase | Phase 3 |
What the finished NCT01690299 record still lists
NCT01690299 is an interventional study that assigns participants to a tested intervention. The registered 250 participants enrollment target is mid-sized for trials with a published cap, below the 487-participant average among 125 other Psoriasis trials with a reported enrollment target (49% lower).
The record links to 2 conditions, with Psoriasis appearing as the primary indexed condition, and to 4 interventions - of which Apremilast is the first listed.
NCT01690299 names 20 study sites across 13 states, led by Florida, California, Illinois.
Frequently Asked Questions
What is clinical trial NCT01690299 about?
NCT01690299 is a clinical study titled "Phase 3b Safety and Efficacy Study of Apremilast to Treat Moderate to Severe Plaque-plaque Psoriasis". This study will test the clinical effectiveness and safety of apremilast compared with placebo as well as etanercept compared with placebo in the same group of patients with moderate to severe plaque psoriasis.
What is the current status of trial NCT01690299?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 250 participants. The study started on 2012-10-01. Estimated completion is 2016-04-04.
What conditions does trial NCT01690299 study?
This clinical trial studies the following conditions: Psoriasis, Psoriatic Arthritis.
What interventions are being tested in trial NCT01690299?
The interventions under investigation include: Apremilast (DRUG), Placebo tablet (DRUG), Etanercept (DRUG), Placebo injection (DRUG).
Who is sponsoring clinical trial NCT01690299?
This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01690299 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01690299's enrollment target sits among peer trials
250 32nd of 125 higher than 93 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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