CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 844 enrolled
Drug / intervention
Apremilast +2 moredrug
Likely dose
Not stated in 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/NCT01194219
NCT01194219Phase 3Completed
CompareCT.gov

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Efficacy and Safety Study of Apremilast (CC-10004) in Subjects With Moderate to Severe Plaque Psoriasis

Amgen·interventional·Posted Sep 2, 2010·Updated Mar 15, 2022

In Brief

A Phase 3 clinical trial evaluating Apremilast, Placebo, and 1 other intervention for Plaque Psoriasis. Completed, enrolled 844 participants.

Detailed Summary

This study evaluated the effects of an called apremilast. Apremilast works by lowering some of the chemicals that affect psoriasis and therefore improves the symptoms of psoriasis. The purpose of this study was to test apremilast and compare its effects to placebo (an inactive substance which contains no medicine but is in the same form as the drug). This study was able to test for efficacy (improvement of signs and symptoms) and safety of apremilast in patients with moderate to severe psoriasis.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPlaque Psoriasis
Countries--
Collaborators--

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedSep 2, 2010
Enrollment StartSep 9, 2010
Primary CompletionFeb 23, 2012
Study CompletionNov 22, 2016
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 15.8 years ago

Interventions

Apremilastdrug

Placebodrug

Identical matching placebo

Topical treatments or phototherapydrug

At week 32, participants considered partial responders or non-responders had the option of adding topical therapies and/or phototherapy to their treatment regimen.