NCT03638258

The Safety, Efficacy and Pharmacokinetics of ARQ-151 Cream in Subjects With Chronic Plaque Psoriasis

A Phase 2b 12-Week Parallel Group, Double Blind, Vehicle-Controlled Study of the Safety, Efficacy and Pharmacokinetics of ARQ-151 Cream 0.3% and ARQ-151 Cream 0.15% Administered Once Daily in Subjects With Chronic Plaque Psoriasis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 331 (actual)
• Sponsor: Arcutis Biotherapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a parallel group, double blind, vehicle-controlled study in which roflumilast (ARQ-151) cream 0.3%, roflumilast cream 0.15%, or vehicle cream is applied once daily (QD) for 84 days to subjects with chronic plaque psoriasis involving between 2 and 20% body surface area.

Conditions

• Plaque Psoriasis

Interventions

Type	Name	Description
DRUG	Roflumilast Cream 0.3%	Applied once daily for 12 weeks
DRUG	Roflumilast Cream 0.15%	Applied once daily for 12 weeks
DRUG	Vehicle Cream	Applied once daily for 12 weeks

Timeline

• Start date: 2018-09-21
• Primary completion: 2019-05-29
• Completion: 2019-05-29
• First posted: 2018-08-20
• Last updated: 2022-09-02
• Results posted: 2022-08-10

Locations

30 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study