At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 250 enrolled
Drug / intervention
Apremilast +3 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.
A Phase 3B, Multicenter, Randomized, Placebo-Controlled, Double-Blind, Double-Dummy, Study Of The Efficacy And Safety Of Apremilast (CC-10004), Etanercept, And Placebo, In Subjects With Moderate To Severe Plaque Psoriasis
In Brief
A Phase 3 clinical trial evaluating Apremilast, Etanercept, and 2 other interventions for Psoriasis and Psoriatic Arthritis. Completed, enrolled 250 participants across 82 sites in 11 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPsoriasis, Psoriatic Arthritis
CountriesAustralia, Belgium, Canada, Czechia, Estonia, Germany, Hungary, Latvia, Netherlands, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedSep 2012
Enrollment StartOct 2012
Primary CompletionJul 2014
Study CompletionApr 2016
TodayJul 2026
First PostedSep 21, 2012
Enrollment StartOct 1, 2012
Primary CompletionJul 3, 2014
Study CompletionApr 4, 2016
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 13.8 years ago
Interventions
Apremilastdrug
Apremilast 30 mg tablet orally BID
Etanerceptdrug
Etanercept 50 mg evaluator/subject-blinded SC QW injection
Placebo tabletdrug
Placebo tablets BID
Placebo injectiondrug
Once weekly evaluator/subject-blinded SC placebo (1 mL x 2 injections SC)