CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 303 enrolled
Drug / intervention
Apremilast +1 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/NCT03123471
NCT03123471Phase 3Completed
CompareCT.gov

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

Amgen·interventional·Posted Apr 21, 2017·Updated May 13, 2020

In Brief

A Phase 3 clinical trial evaluating Apremilast and Placebo for Psoriasis. Completed, enrolled 303 participants across 45 sites in 2 countries.

Detailed Summary

This is a Phase 3, multicenter, randomized, placebo-controlled, double-blind study of the efficacy and safety of apremilast (CC-10004) in subjects with moderate to severe plaque psoriasis of the scalp. Approximately 300 subjects with moderate to severe plaque psoriasis of the scalp will be randomized 2:1 to receive either apremilast 30 mg twice daily (BID) or placebo for the first 16 weeks.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPsoriasis
CountriesCanada, United States
Collaborators--

Timeline

Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedApr 21, 2017
Enrollment StartMay 16, 2017
Primary CompletionAug 13, 2018
Study CompletionJan 9, 2019
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 9.2 years ago

Interventions

Apremilastdrug

Apremilast 30 mg tablets BID from weeks 0 to 32.

Placeboother

Placebo tablets twice daily (BID) for 16 weeks; placebo participants were switched to apremilast 30 mg at week 16.