NCT04128007

Safety and Efficacy of ARQ-154 Foam in Adolescent and Adult Subjects With Scalp and Body Psoriasis

A Phase 2b, 8-Week, Parallel Group, Double Blind, Vehicle-Controlled Study of the Safety and Efficacy of ARQ-154 Foam 0.3% Administered QD in Adolescents and Adults With Scalp and Body Psoriasis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 304 (actual)
• Sponsor: Arcutis Biotherapeutics, Inc. · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

This study will assess the safety and efficacy of ARQ-154 foam vs placebo applied once a day for 56 days by subjects with scalp and body psoriasis

Detailed description

This is a parallel group, double blind, vehicle-controlled study in which ARQ-154 foam or vehicle is applied once daily x 8 weeks to adolescent and adult subjects with scalp and body psoriasis

Conditions

• Plaque Psoriasis

Interventions

Type	Name	Description
DRUG	Roflumilast foam 0.3%	experimental
DRUG	Vehicle foam	experimental

Timeline

• Start date: 2020-01-13
• Primary completion: 2020-09-23
• Completion: 2020-09-25
• First posted: 2019-10-16
• Last updated: 2022-10-26
• Results posted: 2022-09-30

Locations

47 sites across 4 countries: United States, Australia, Bulgaria, Canada

Regulatory

• FDA-regulated drug study