Trial of PDE4 Inhibition With Roflumilast for the Management of Plaque Psoriasis

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.

Timeline

Start

2019-12-20

Primary completion

2020-11-16

Completion

2020-11-16

Publications

• Papp KA, Del Rosso JQ, Lebwohl MG, Gooderham MJ, Hebert AA, Hong HC, Kircik LH, Pariser DM, Stein Gold L, Strober B, Seal MS, Krupa D, Chu DH, Burnett P, Berk DR, Higham RC. Roflumilast Cream 0.3% in Patients with Chronic Plaque Psoriasis: Pooled PASI and PASI-HD Results from the DERMIS Phase III Trials. Dermatol Ther (Heidelb). 2025 Dec;15(12):3733-3744. doi: 10.1007/s13555-025-01562-4. Epub 2025 Oct 24.
• Thurston AW Jr, Osborne DW, Snyder S, Higham RC, Burnett P, Berk DR. Pharmacokinetics of Roflumilast Cream in Chronic Plaque Psoriasis: Data from Phase I to Phase III Studies. Am J Clin Dermatol. 2023 Mar;24(2):315-324. doi: 10.1007/s40257-022-00741-9. Epub 2022 Nov 24.
• Lebwohl MG, Kircik LH, Moore AY, Stein Gold L, Draelos ZD, Gooderham MJ, Papp KA, Bagel J, Bhatia N, Del Rosso JQ, Ferris LK, Green LJ, Hebert AA, Jones T, Kempers SE, Pariser DM, Yamauchi PS, Zirwas M, Albrecht L, Devani AR, Lomaga M, Feng A, Snyder S, Burnett P, Higham RC, Berk DR. Effect of Roflumilast Cream vs Vehicle Cream on Chronic Plaque Psoriasis: The DERMIS-1 and DERMIS-2 Randomized Clinical Trials. JAMA. 2022 Sep 20;328(11):1073-1084. doi: 10.1001/jama.2022.15632.

Drugs

Indications