Trials / Completed
CompletedNCT04211363
Trial of PDE4 Inhibition With Roflumilast for the Management of Plaque Psoriasis
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
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 439 (actual)
- Sponsor
- Arcutis Biotherapeutics, Inc. · Industry
- Sex
- All
- Age
- 2 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Roflumilast 0.3% cream | Roflumilast 0.3% cream for topical application. |
| DRUG | Vehicle Cream | Vehicle cream for topical application. |
Timeline
- Start date
- 2019-12-20
- Primary completion
- 2020-11-16
- Completion
- 2020-11-16
- First posted
- 2019-12-26
- Last updated
- 2022-12-07
- Results posted
- 2022-11-03
Locations
40 sites across 2 countries: United States, Canada
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04211363. Inclusion in this directory is not an endorsement.