Pharmacokinetics (PK), Safety, Efficacy and Maximal Use PK of ARQ-151 in Adolescents/Children With Mild/Moderate Eczema
Status:
Recruiting
Trial end date:
2021-11-01
Target enrollment:
Participant gender:
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 4-7), subjects will have BSA involvement (excluding
the scalp, palms, soles) of ≥ 35% in subjects 2 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)
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.