An Open Label, Phase 1, Maximal Usage Pharmacokinetics and Safety Study of ARQ-154 Foam 0.3% Administered QD in Pediatric Participants With Scalp and Body Psoriasis
Arcutis Biotherapeutics, Inc.
Summary
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%.
Description
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%
Eligibility
- Age range
- 2–12 years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DrugARQ-154 Foam 0.3%
ARQ-154 Foam 0.3%
Locations (5)
- Arcutis Clinical Study Site 106Bryant, Arkansas
- Arcutis Clinical Study Site 107Miami Lakes, Florida
- Arcutis Clinical Study Site 108Meridian, Idaho
- Arcutis Clinical Study Site 105West Lafayette, Indiana
- Arcutis Clinical Study Site 104Arlington, Texas