NCT04279119

Maximal Usage Pharmacokinetics and Safety of ARQ-151 in Adolescents and Adults With Chronic Plaque Psoriasis

An Open Label, Phase 1, Maximal Usage Pharmacokinetics and Safety Study of ARQ-151 Cream 0.3% Administered QD in Adolescent and Adult Subjects With Chronic Plaque Psoriasis

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Arcutis Biotherapeutics, Inc. · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

This is a phase 1, open label, single arm study in which ARQ-151 cream 0.3% is applied QD for 2 weeks to adolescent subjects with chronic plaque psoriasis involving at least 10% body surface area (BSA) and adult subjects with chronic plaque psoriasis involving at least 20% BSA (excluding scalp). The objectives of this study are to evaluate the exposure and characterize the plasma pharmacokinetic profile and to assess the safety and tolerability of ARQ-151 cream 0.3% administered once daily for 2 weeks to adolescent and adult subjects with chronic plaque psoriasis.

Conditions

• Plaque Psoriasis

Interventions

Type	Name	Description
DRUG	ARQ-151- cream 0.3%	ARQ-151 cream 0.3% applied to chronic plaque psoriasis lesions once a day for 2 weeks

Timeline

• Start date: 2020-03-10
• Primary completion: 2021-03-25
• Completion: 2021-03-25
• First posted: 2020-02-20
• Last updated: 2022-08-03

Locations

12 sites across 1 country: United States

Regulatory

• FDA-regulated drug study