CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 331 enrolled
Drug / intervention
Roflumilast Cream 0.3% +2 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/NCT03638258
NCT03638258Phase 2Completed
CompareCT.gov

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

Arcutis Biotherapeutics, Inc.·interventional·Posted Aug 20, 2018·Updated Sep 2, 2022

In Brief

A Phase 2 clinical trial evaluating Roflumilast Cream 0.3%, Roflumilast Cream 0.15%, and 1 other intervention for Plaque Psoriasis. Completed, enrolled 331 participants across 30 sites in 2 countries.

Detailed 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.

Study Details

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

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedAug 20, 2018
Enrollment StartSep 21, 2018
Primary CompletionMay 29, 2019
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 7.9 years ago

Interventions

Roflumilast Cream 0.3%drug

Applied once daily for 12 weeks

Roflumilast Cream 0.15%drug

Applied once daily for 12 weeks

Vehicle Creamdrug

Applied once daily for 12 weeks