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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
101
ARQ-151 cream 0.15% applied to atopic dermatitis lesions once a day for 28 days
ARQ-151 cream 0.05% applied to atopic dermatitis lesions once a day for 28 days
Arcutis Clinical Site 07
Birmingham, Alabama, United States
Arcutis Clinical Site 11
Rancho Santa Margarita, California, United States
Arcutis Clinical Site 02
Coral Gables, Florida, United States
Arcutis Clinical Site 05
Hialeah, Florida, United States
Arcutis Clinical Site 13
Miami, Florida, United States
Arcutis Clinical Site 01
Mt. Pleasant, South Carolina, United States
Arcutis Clinical Site 06
San Antonio, Texas, United States
Arcutis Clinical Site 03
Orem, Utah, United States
Arcutis Clinical Site 10
West Jordan, Utah, United States
Arcutis Clinical Site 12
Spokane, Washington, United States
Maximum Plasma Concentration (Cmax) of roflumilast and its N-oxide metabolite
Maximum observed plasma concentration of drug in plasma
Time frame: 4 weeks
Area under the plasma concentration-time curve within a dosing interval (AUC) for roflumilast and its N-oxide metabolite
The area under the plasma concentration-time curve (AUC) is a method of measurement of the total exposure of a drug in plasma.
Time frame: 4 weeks
Treatment Emergent Adverse Events (TEAE)
Number of participants with adverse events during treatment will be assessed.
Time frame: 4 weeks
Eczema Area and Severity Index (EASI) Total Score Change and Percent Change in Total Score
Change in EASI Total Score at weeks 2 and 4 and percent change from baseline in EASI Total Score at weeks 2 and 4. EASI combines the assessment of the severity of lesions and the area affected into a single total score in the range 0 (no disease) to 72 (maximal disease). To calculate the EASI, the sum of the severity rating (0 to 3 with 3 being the most severe) for four clinical signs are multiplied with the numerical value of the area affected and with the percentage of the four body areas.
Time frame: Baseline, Week 2, and Week 4
Eczema Area and Severity Index Score 100%, 90%, 75%, and 50% Improvement (EASI100, EASI90, EASI75, and EASI50)
Proportion of patients with a 100%, 90%, 75%, and 50% or greater improvement in Eczema Area and Severity Index (EASI100, EASI90, EASI75, and EASI50) score from baseline to each study visit. EASI combines the assessment of the severity of lesions and the area affected into a single total score in the range 0 (no disease) to 72 (maximal disease). To calculate the EASI, the sum of the severity rating (0 to 3 with 3 being the most severe) for four clinical signs are multiplied with the numerical value of the area affected and with the percentage of the four body areas.
Time frame: Baseline, Week 2, and Week 4
Achievement of a Validated Investigator Global Assessment scale for Atopic Dermatitis (vIGA-AD) score of 'clear' or 'almost clear' at each study visit, or 'clear' or 'almost clear' with a 2-point improvement from baseline at each study visit
The vIGA-AD is a static evaluation of qualitative overall AD severity. This global assessment scale is an ordinal scale with five severity grades (reported only in integers of 0 to 4 where 0 is clear).
Time frame: Baseline, Week 2, Week 4
Change from baseline in vIGA-AD score at each study visit
The vIGA-AD is a static evaluation of qualitative overall AD severity. This global assessment scale is an ordinal scale with five severity grades (reported only in integers of 0 to 4 where 0 is clear).
Time frame: Baseline, Week 2, Week 4
Body Surface Area (BSA) Involvement Change
Change from baseline in BSA involvement at each study visit.
Time frame: Baseline, Week 2, Week 4
Worse Itch Numerical Rating Score (WI-NRS) Pruritis Score Change
Change from baseline in WI-NRS pruritus score at each study visit. WI-NRS is a subject-reported severity of itch at its highest intensity during the previous 24-hour period. The scale is from '0 to 10' ("no itch" to "worst imaginable itch").
Time frame: Baseline, Week 2, Week 4
WI-NRS Pruritus Score Improvement
≥4-point improvement from Baseline in WI-NRS pruritus score at each study visit. WI-NRS is a subject-reported severity of itch at its highest intensity during the previous 24-hour period. The scale is from '0 to 10' ("no itch" to "worst imaginable itch").
Time frame: Baseline, Week 2, Week 4
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