At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 289 enrolled
Drug / intervention
Apremilast +1 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.
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 Genital Psoriasis
In Brief
A Phase 3 clinical trial evaluating Apremilast and Placebo for Psoriasis. Completed, enrolled 289 participants across 52 sites in 7 countries.
Detailed Summary
This Phase 3 multicenter, randomized, placebo-controlled, double-blind study is designed to evaluate the efficacy and safety of apremilast in subjects with moderate to severe genital psoriasis (modified sPGA-G ≥3, moderate or severe). Approximately 286 subjects with moderate to severe genital psoriasis will be randomized 1:1 to receive either apremilast 30 mg BID or placebo for the first 16 weeks.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPsoriasis
CountriesBelgium, Canada, France, Germany, Italy, Puerto Rico, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20192020202120222023202420252026
First PostedDec 2018
Enrollment StartFeb 2019
Primary CompletionSep 2021
Study CompletionFeb 2022
TodayJul 2026
First PostedDec 17, 2018
Enrollment StartFeb 11, 2019
Primary CompletionSep 23, 2021
Study CompletionFeb 9, 2022
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 7.5 years ago
Interventions
Apremilastdrug
Oral
Placeboother
Oral