The Safety, Efficacy and Pharmacokinetics of ARQ-151 Cream in Subjects With Chronic Plaque Psoriasis

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.

Timeline

Start

2018-09-21

Primary completion

2019-05-29

Completion

2019-05-29

Outcome

Met primary endpoint

registry analysis (superiority test); Roflumilast Cream 0.3% vs Vehicle Cream; p <0.001; Regression, Logistic NCT03638258 ↗

registry analysis (superiority test); Roflumilast Cream 0.15% vs Vehicle Cream; p = 0.004; Regression, Logistic NCT03638258 ↗

Publications

• Stein Gold L, Alonso-Llamazares J, Draelos ZD, Gooderham MJ, Kempers SE, Kircik LH, Lebwohl MG, Papp KA, Pariser DM, Toth DP, Yosipovitch G, Higham RC, Feng A, Berk DR. Effect of Roflumilast Cream (ARQ-151) on Itch and Itch-Related Sleep Loss in Adults with Chronic Plaque Psoriasis: Patient-Reported Itch Outcomes of a Phase 2b Trial. Am J Clin Dermatol. 2023 Mar;24(2):305-313. doi: 10.1007/s40257-022-00739-3. Epub 2022 Nov 12.
• Lebwohl MG, Papp KA, Stein Gold L, Gooderham MJ, Kircik LH, Draelos ZD, Kempers SE, Zirwas M, Smith K, Osborne DW, Trotman ML, Navale L, Merritt C, Berk DR, Welgus H; ARQ-151 201 Study Investigators. Trial of Roflumilast Cream for Chronic Plaque Psoriasis. N Engl J Med. 2020 Jul 16;383(3):229-239. doi: 10.1056/NEJMoa2000073.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Roflumilast	Small molecule	0.15 %	Topical
Subject	Roflumilast	Small molecule	0.3 %	Topical

Indications