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NCT02425826 · ClinicalTrials.gov registry record · Phase 4

A Phase 4 Study of Efficacy and Safety of Apremilast in Subjects With Moderate Plaque Psoriasis.

A Phase 4 study of Parapsoriasis, sponsored by Amgen.

Completed
Registry status
Phase 4
Development phase
221
Enrollment target
20
Study locations

NCT02425826: Completed Phase 4 study of Parapsoriasis, sponsored by Amgen.

NCT02425826 is a Phase 4 study of Parapsoriasis that has completed, run by Amgen. The registered enrollment target is 221 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (57% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02425826, a Phase 4 study of Parapsoriasis, has completed, sponsored by Amgen.

COMPLETED
Registry status
Phase 4
Development phase
221 participants
Enrollment target
20
Study locations

Study Summary

This study will evaluate the clinical efficacy, the patients quality of life, and safety of oral apremilast 30 mg twice daily (BID) compared to placebo, in adult patients with moderate plaque psoriasis during the 16 week Placebo controlled Phase and then upto 1 year in the Extension Phase of the trial.

Primary Outcome

BSA is a measurement of involved skin. The overall BSA affected by psoriasis is estimated based on the palm area of the participant's hand (entire palmar surface or "handprint" including the fingers), which equates to approximately 1% of total body surface area. The sPGA is a 6-point scale ranging from 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate), to 4 (severe), 5 (very severe) incorporating a separate assessment of the severity of the three primary signs of the plaques of all involved ar

Conditions Studied

Interventions

  • DRUG Placebo
  • DRUG Apremilast
  • DRUG Placebo-Apremilast

Study Locations (20)

California

  • Center For Dermatology - Fremont
  • Dermatology Research Associates - Los Angeles
  • Blue Harbor Dermatology - Newport Beach
  • Center for Dermatology and Laser Surgery - Sacramento
  • East Bay Rheumatology Medical - San Leandro
  • Tien Q. Nguyen MD Inc - Tustin

Florida

  • Dermatology Associates - Panama City
  • USF Health Faculty Office Building-FOB - Tampa
  • Forward Clinical Trials Inc - Tampa

Kentucky

  • Dermatology Specialists, PSC - Louisville
  • DermResearch, PLLC - Louisville

Alabama

  • UAB at Birmingham - The Kirklin Clinic - Birmingham

Connecticut

  • UConn Health Center - Farmington

Georgia

  • Dermatologic Surgery Specialists, P.C. - Macon

Indiana

  • Shideler Clinical Research Center - Carmel

Maryland

  • Lawrence Green, MD, LLC - Rockville

Trial Details

FieldValue
Enrollment Target 221 participants
Start Date 2015-04-20
Est. Completion 2016-11-22
Phase Phase 4
Amgen

558 total trials

What the finished NCT02425826 record still lists

NCT02425826 is an interventional study that assigns participants to a tested intervention. The registered 221 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (57% lower).

The record links to 1 condition, with Parapsoriasis appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.

NCT02425826 names 20 study sites across 12 states, led by California, Florida, Kentucky.

Frequently Asked Questions

What is clinical trial NCT02425826 about?

NCT02425826 is a clinical study titled "A Phase 4 Study of Efficacy and Safety of Apremilast in Subjects With Moderate Plaque Psoriasis.". This study will evaluate the clinical efficacy, the patients quality of life, and safety of oral apremilast 30 mg twice daily (BID) compared to placebo, in adult patients with moderate plaque psoriasis during the 16 week Placebo controlled Phase and then upto 1 year in the Extension Phase of the tri...

What is the current status of trial NCT02425826?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 221 participants. The study started on 2015-04-20. Estimated completion is 2016-11-22.

What conditions does trial NCT02425826 study?

This clinical trial studies the following conditions: Parapsoriasis.

What interventions are being tested in trial NCT02425826?

The interventions under investigation include: Placebo (DRUG), Apremilast (DRUG), Placebo-Apremilast (DRUG).

Who is sponsoring clinical trial NCT02425826?

This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02425826 being conducted?

This trial has 20 study locations across Alabama, California, Connecticut, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

How this trial's enrollment target compares

Where NCT02425826's enrollment target sits among peer trials

221 383rd of 2000 higher than 1,617 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 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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Source: ClinicalTrials.gov NCT02425826, the US trial registry maintained by the National Library of Medicine. NCT02425826 (mid enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.