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Safety, Pharmacokinetics and Efficacy of ARQ-151 Cream in Adults With Mild to Moderate Chronic Plaque Psoriasis

Brief Summary:
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

Detailed Description:
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
Allocation:Randomized
Intervention Model:Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description: Cohort 1 is open label. Cohort 2 is double blind.
Primary Purpose: Treatment
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
Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

U.S. FDA Resources

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