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

NCT04156191 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 101

Last updated 2023-07-24

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Arcutis Biotherapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • David Berk, MD · Arcutis Biotherapeutics, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
3 Months
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-23
Primary Completion
2023-05-02
Completion
2023-05-02
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04156191 on ClinicalTrials.gov