CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 439 enrolled
Drug / intervention
Roflumilast 0.3% cream +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04211363
NCT04211363Phase 3Completed

A Phase 3, 8-Week, Parallel Group, Double Blind, Vehicle-Controlled Study of the Safety and Efficacy of ARQ-151 Cream 0.3% Administered QD in Subjects With Chronic Plaque Psoriasis

Arcutis Biotherapeutics, Inc.·interventional·Posted Dec 26, 2019·Updated Dec 7, 2022

In Brief

A Phase 3 clinical trial evaluating Roflumilast 0.3% cream and Vehicle Cream for Chronic Plaque Psoriasis. Completed, enrolled 439 participants across 40 sites in 2 countries.

Detailed Summary

This is a double-blind, parallel group, vehicle-controlled study to assess the safety and efficacy of roflumilast (ARQ-151) 0.3% cream vs vehicle (placebo) cream for treatment of chronic plaque psoriasis (CPP) in adult participants with 2 to 20% body surface area (BSA) of CPP.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2020202120222023202420252026
First PostedDec 26, 2019
Enrollment StartDec 20, 2019
Primary CompletionNov 16, 2020
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 6.5 years ago

Interventions

Roflumilast 0.3% creamdrug

Roflumilast 0.3% cream for topical application.

Vehicle Creamdrug

Vehicle cream for topical application.