Arcutis Biotherapeutics, Inc.
This study will evaluate the systemic exposure and characterize the plasma pharmacokinetic (PK) profile and assess the safety and tolerability of ARQ-154 foam 0.3%.
ARQ-154-127 is a Phase 1, open-label, single arm, maximum usage pharmacokinetic and safety study of roflumilast foam 0.3% in participants with scalp and body psoriasis. The goal of the study is to: * Evaluate the systemic exposure and characterize the plasma pharmacokinetic (PK) profile of ARQ-154 foam 0.3%. * Assess the safety and tolerability of ARQ-154 foam 0.3%
Inclusion Criteria: * Males and females, ages 2 years to \< 12 years old at Day 1. * Clinical diagnosis of psoriasis vulgaris of at least 2 months duration at Screening as determined by the Investigator. * Scalp psoriasis with an Investigator Global Assessment (S-IGA) of scalp disease severity of at least Moderate ('3') at Day 1. * An IGA of body (non-scalp) psoriasis (B-IGA) of at least Mild ('2') at Day 1. * Extent of scalp psoriasis involving ≥ 10% of the total scalp at Day 1. * Body psoriasis (non-scalp) involving at least 3% BSA on Day 1. Exclusion Criteria: * Participants who cannot d…
ARQ-154 Foam 0.3%
Arctuva estimate
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