Calendario›ARQT›ARQ-151 cream 0.15%

ARQ-151 cream 0.15%

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

Ensayo de Arcutis Biotherapeutics, Inc. en Dermatitis atopica (eccema).

Fase

Fase 1

Estado

Completado

Participantes

101

previstos

Centros

10

Fin del objetivo primario

may 2023

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, de un solo grupo, abierto. Comenzó en dic 2019.

Qué mide

Concentracion plasmatica maxima (Cmax) de roflumilast y su metabolito N-oxido (4 semanas)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThis 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.

Más ensayos de ARQT

Todos los de ARQT, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT04156191), actualizada en jul 2023.