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NCT04156191 · ClinicalTrials.gov registry record · Phase 1
Pharmacokinetics (PK), Safety, Efficacy and Maximal Use PK of ARQ-151 in Adolescents/Children With Mild/Moderate Eczema
A Phase 1 study, sponsored by Arcutis Biotherapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 101
- Enrollment target
NCT04156191 is a Phase 1 study that has completed, run by Arcutis Biotherapeutics. The registered enrollment target is 101 participants.
The verdict
NCT04156191, a Phase 1 study, has completed, sponsored by Arcutis Biotherapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 101 participants
- Enrollment target
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.
Interventions
- DRUG ARQ-151 cream 0.15%
- DRUG ARQ-151 cream 0.05%
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 101 participants |
| Start Date | 2019-12-23 |
| Est. Completion | 2023-05-02 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04156191
The ClinicalTrials.gov registry entry for NCT04156191 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 101 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Arcutis Biotherapeutics, which has 25 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which ARQ-151 cream 0.15% is the first listed.
NCT04156191 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04156191 about?
NCT04156191 is a clinical study titled "Pharmacokinetics (PK), Safety, Efficacy and Maximal Use PK of ARQ-151 in Adolescents/Children With Mild/Moderate Eczema". 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 Cohor...
What is the current status of trial NCT04156191?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 101 participants. The study started on 2019-12-23. Estimated completion is 2023-05-02.
What interventions are being tested in trial NCT04156191?
The interventions under investigation include: ARQ-151 cream 0.15% (DRUG), ARQ-151 cream 0.05% (DRUG).
Who is sponsoring clinical trial NCT04156191?
This trial is sponsored by Arcutis Biotherapeutics, which has 25 total clinical trials registered on ClinicalTrials.gov.
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