At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 332 enrolled
Drug / intervention
Roflumilastdrug
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 2, Multicenter, Open-Label Extension Study of the Long-Term Safety of ARQ-151 Cream 0.3% in Adult Subjects With Chronic Plaque Psoriasis Who Have Completed Preceding Study ARQ-151-201 Phase 2 Randomized Controlled Trial (Cohort 1) and Non-ARQ-151-201 Subjects (Cohort 2)
In Brief
A Phase 2 clinical trial evaluating Roflumilast for Plaque Psoriasis. Completed, enrolled 332 participants across 30 sites in 2 countries.
Detailed Summary
This is an open-label, long-term safety study of roflumilast (ARQ-151) 0.3% cream in subjects with chronic plaque psoriasis involving up to 25% total Body Surface Area (BSA). Study medication will be applied by the qualifying subjects topically once daily for 52 weeks at home. Periodic clinic visits will include assessments for clinical safety, application site reactions, and disease improvement or progression.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPlaque Psoriasis
CountriesCanada, United States
Collaborators--
Timeline
Phase 2CompletedFinished
20192020202120222023202420252026
First PostedDec 2018
Enrollment StartDec 2018
Primary CompletionOct 2020
TodayJul 2026
First PostedDec 5, 2018
Enrollment StartDec 18, 2018
Primary CompletionOct 8, 2020
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 7.6 years ago
Interventions
Roflumilastdrug
Roflumilast cream 0.3% for topical application