NCT04156191

Pharmacokinetics (PK), Safety, Efficacy and Maximal Use PK of ARQ-151 in Adolescents/Children With Mild/Moderate Eczema

An Open Label, Phase 1, Pharmacokinetics, Maximal Usage Pharmacokinetics, Safety, and Efficacy Study of ARQ-151 Cream 0.15% or ARQ-151 Cream 0.05% Administered QD in Adolescent and Pediatric Subjects With Mild to Moderate Atopic Dermatitis

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 101 (actual)
• Sponsor: Arcutis Biotherapeutics, Inc. · Industry
• Sex: All
• Age: 3 Months – 17 Years
• Healthy volunteers: Not accepted

Summary

This is a research study where all subjects will receive study medication to understand how the body processes the study medication, and to determine the PK, safety and efficacy of ARQ-151 cream 0.15% or 0.05% in adolescent and pediatric subjects with mild to moderate AD. At entry, subjects in Cohorts 1-3 will have 1.5-35% Body Surface Area involvement (excluding the scalp, palms, soles) and mild or moderate atopic dermatitis (AD) based on vIGA-AD. Cohort 2 and Cohort 3 will be performed in parallel and may commence after results are available from ARQ-151-212, a Phase 2 study evaluating ARQ-151 cream 0.05% and 0.15% administered once a day for 4 weeks in adolescents and adults with mild to moderate AD affecting 1.5% to 35% BSA. For the maximal usage PK study (Cohorts 4-8), subjects will have BSA involvement (excluding the scalp, palms, soles) of ≥ 35% in subjects 3 months old to 11 years old (inclusive) or ≥25% in subjects 12 to \<17 years old with mild or moderate AD . Seven groups will be evaluated, including: * Cohort 1: ARQ-151 cream 0.15% in adolescents (12-17 years old; inclusive) * Cohort 2: ARQ-151 cream 0.15% in children 6-11 years old (inclusive) * Cohort 3: ARQ-151 cream 0.15% in children 2-5 years old (inclusive; will be performed in parallel with Cohort 2) * Cohort 4: ARQ-151 cream 0.15% in adolescents 12 to \<17 years old * Cohort 5: ARQ-151 cream 0.15% in children 6-11 years old (inclusive) * Cohort 6: ARQ-151 cream 0.15% in children 2-5 years old (inclusive) * Cohort 7: ARQ-151 cream 0.05% in children 2-5 years old (inclusive) * Cohort 8: ARQ-151 cream 0.05% in children 3 months old to less than 2 years old Subjects will apply ARQ-151 cream 0.15% or 0.05% once a day for 28 days to all AD affected areas and any newly appearing AD lesions that arise during the study, except on the scalp.

Conditions

• Atopic Dermatitis (Eczema)

Interventions

Type	Name	Description
DRUG	ARQ-151 cream 0.15%	ARQ-151 cream 0.15% applied to atopic dermatitis lesions once a day for 28 days
DRUG	ARQ-151 cream 0.05%	ARQ-151 cream 0.05% applied to atopic dermatitis lesions once a day for 28 days

Timeline

• Start date: 2019-12-23
• Primary completion: 2023-05-02
• Completion: 2023-05-02
• First posted: 2019-11-07
• Last updated: 2023-07-24

Locations

10 sites across 1 country: United States

Regulatory

• FDA-regulated drug study