CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 221 enrolled
Drug / intervention
Apremilast +2 moredrug
Likely dose
Apremilast 30 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02425826
NCT02425826Phase 4Completed
CompareCT.gov

A Phase 4, Multicenter, Randomized, Placebo-controlled, Double-blind, Study of the Efficacy and Safety of Apremilast (CC-10004) in Subjects With Moderate Plaque Psoriasis

Amgen·interventional·Posted Apr 24, 2015·Updated Jun 5, 2023

In Brief

A Phase 4 clinical trial evaluating Apremilast, Placebo, and 1 other intervention for Parapsoriasis. Completed, enrolled 221 participants across 26 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsParapsoriasis
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
201520162017201820192020202120222023202420252026
First PostedApr 24, 2015
Enrollment StartApr 20, 2015
Primary CompletionFeb 12, 2016
Study CompletionNov 22, 2016
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 11.2 years ago

Interventions

Apremilastdrug

Apremilast 30 mg tablets orally twice daily (BID) weeks 0 to 52.

Placebodrug

Participants randomized to the placebo treatment group received placebo tablets (identical in appearance to the apremilast 30 mg tablets) orally BID for from weeks 0-16.

Placebo-Apremilastdrug

At Week 16, those randomized to placebo were switched to apremilast 30mg BID for an additional 36 weeks (52 weeks total)