NCT07340216

Maximal Usage Pharmacokinetics and Safety Study of ARQ-154 Foam 0.3% in Pediatric Participants With Scalp and Body Psoriasis

An Open Label, Phase 1, Maximal Usage Pharmacokinetics and Safety Study of ARQ-154 Foam 0.3% Administered QD in Pediatric Participants With Scalp and Body Psoriasis

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (estimated)
• Sponsor: Arcutis Biotherapeutics, Inc. · Industry
• Sex: All
• Age: 2 Years – 12 Years
• Healthy volunteers: Not accepted

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%.

Detailed description

ARQ-154-127 is a Phase 1, open-label, single arm, maximum usage pharmacokinetic and safety study of roflumilast foam 0.3% in participants with scalp and body psoriasis. The goal of the study is to: * Evaluate the systemic exposure and characterize the plasma pharmacokinetic (PK) profile of ARQ-154 foam 0.3%. * Assess the safety and tolerability of ARQ-154 foam 0.3%

Conditions

• Psoriasis

Interventions

Type	Name	Description
DRUG	ARQ-154 Foam 0.3%	ARQ-154 Foam 0.3%

Timeline

• Start date: 2025-12-15
• Primary completion: 2026-12-01
• Completion: 2027-02-01
• First posted: 2026-01-14
• Last updated: 2026-01-14

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study