drugset / Trial / NCT04128007

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

NCT04128007 ↗

Phase 2 Completed 304 enrolled Arcutis Biotherapeutics, Inc.
RandomizedParallel-groupQuadruple-blindTreatment

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

Timeline

Start
2020-01-13
Primary completion
2020-09-23
Completion
2020-09-25

Outcome

Met primary endpoint

registry analysis (superiority test); Roflumilast Foam 0.3% vs Vehicle Foam; p <0.0001; Odds Ratio (OR) 14.65 (95% CI 6.64 to 32.32); Cochran-Mantel-Haenszel NCT04128007 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Roflumilast Small molecule 0.3 % —

Indications