This study is designed to assess the safety and pharmacokinetics (PK) of a single dose application of ARQ-151 cream 0.5% to 25 cm2 of psoriatic plaque(s) (Cohort 1). The study will also assess the safety, PK and efficacy of different doses and multiple applications of ARQ-151 cream 0.5% vs placebo and ARQ-151 cream 0.15% vs placebo applied once a day for 28 days to individuals with 0.5% to 5.0% body surface area (BSA) of chronic plaque psoriasis (Cohort 2).
|Condition or disease||Intervention/treatment||Phase|
|Psoriasis||Drug: ARQ-151 cream 0.5% Drug: ARQ-151 cream 0.15% Drug: ARQ-151 cream placebo||Phase 1 Phase 2|
There are 2 cohorts of subjects. Cohort 1 is a single dose study of ARQ-151 0.5% cream applied to 25 cm2 of psoriatic plaque(s) in up to 8 psoriasis subjects. Cohort 2 is a parallel group, double blind, vehicle controlled study in which ARQ-151 cream 0.5%, ARQ-151 cream 0.15% or vehicle cream is applied once a day for 28 days to subjects with between 0.5% to 5.0% BSA of chronic plaque psoriasis. Including both Cohorts, a total of up to 92 subjects will be enrolled at 8 study sites in Canada and the US. Subjects will be adult (≥18 years old) males or females with chronic plaque psoriasis.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||92 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Masking Description:||Cohort 1 is open label. Cohort 2 is double blind.|
|Official Title:||A Phase 1/2a Single Dose and 28-day Parallel Group, Double Blind, Vehicle-Controlled Study of the Safety, Pharmacokinetics and Efficacy of ARQ-151 Cream 0.5% and 0.15% in Adults With Mild to Moderate Chronic Plaque Psoriasis|
|Actual Study Start Date :||December 11, 2017|
|Estimated Primary Completion Date :||May 2018|
|Estimated Study Completion Date :||June 2018|