NCT07340216 Maximal Usage Pharmacokinetics and Safety Study of ARQ-154 Foam 0.3% in Pediatric Participants With Scalp and Body Psoriasis
| NCT ID | NCT07340216 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Arcutis Biotherapeutics, Inc. |
| Condition | Psoriasis |
| Study Type | INTERVENTIONAL |
| Enrollment | 16 participants |
| Start Date | 2025-12-15 |
| Primary Completion | 2026-12 |
Trial Parameters
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Brief Summary
This study will evaluate the systemic exposure and characterize the plasma pharmacokinetic (PK) profile and assess the safety and tolerability of ARQ-154 foam 0.3%.
Eligibility Criteria
Inclusion Criteria: * Males and females, ages 2 years to \< 12 years old at Day 1. * Clinical diagnosis of psoriasis vulgaris of at least 2 months duration at Screening as determined by the Investigator. * Scalp psoriasis with an Investigator Global Assessment (S-IGA) of scalp disease severity of at least Moderate ('3') at Day 1. * An IGA of body (non-scalp) psoriasis (B-IGA) of at least Mild ('2') at Day 1. * Extent of scalp psoriasis involving ≥ 10% of the total scalp at Day 1. * Body psoriasis (non-scalp) involving at least 3% BSA on Day 1. Exclusion Criteria: * Participants who cannot discontinue medications and treatments prior to Day 1 (first application of IP). * Current diagnosis of non-plaque forms of psoriasis. Current diagnosis of drug-induced psoriasis. * Participants who have significant active systemic or localized infection or have had any infection that required oral or intravenous administration of antibiotics, antifungal or antiviral agents within 7 days prior to Day
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