Efficacy and Safety Study of Two Doses of Apremilast (CC-10004) In Japanese Patients With Moderate-To-Severe Plaque-Type Psoriasis

Summary

This study will test the clinical effectiveness and safety of two orally administered doses of apremilast compared to placebo in Japanese patients with moderate-to-severe plaque-type psoriasis.

Timeline

Start

2013-07-09

Primary completion

2014-11-20

Completion

2015-12-15

Outcome

Met primary endpoint

registry Placebo vs Apremilast 20mg; p = 0.0032; Difference 16.4 (95% CI 5.8 to 27.0); Chi-squared NCT01988103 ↗

registry Placebo vs Apremilast 30mg; p = 0.0003; Difference 21.1 (95% CI 10.1 to 32.1); Chi-squared NCT01988103 ↗

Publications

• Background Ohtsuki M, Okubo Y, Komine M, Imafuku S, Day RM, Chen P, Petric R, Maroli A, Nemoto O. Apremilast, an oral phosphodiesterase 4 inhibitor, in the treatment of Japanese patients with moderate to severe plaque psoriasis: Efficacy, safety and tolerability results from a phase 2b randomized controlled trial. J Dermatol. 2017 Aug;44(8):873-884. doi: 10.1111/1346-8138.13829. Epub 2017 Apr 9.
• Background Ohtsuki M, Kubo H, Morishima H, Goto R, Zheng R, Nakagawa H. Guselkumab, an anti-interleukin-23 monoclonal antibody, for the treatment of moderate to severe plaque-type psoriasis in Japanese patients: Efficacy and safety results from a phase 3, randomized, double-blind, placebo-controlled study. J Dermatol. 2018 Sep;45(9):1053-1062. doi: 10.1111/1346-8138.14504. Epub 2018 Jun 15.
• Mease PJ, Hatemi G, Paris M, Cheng S, Maes P, Zhang W, Shi R, Flower A, Picard H, Stein Gold L. Apremilast Long-Term Safety Up to 5 Years from 15 Pooled Randomized, Placebo-Controlled Studies of Psoriasis, Psoriatic Arthritis, and Behcet's Syndrome. Am J Clin Dermatol. 2023 Sep;24(5):809-820. doi: 10.1007/s40257-023-00783-7. Epub 2023 Jun 14.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Apremilast	Small molecule	20 mg	Oral
Subject	Apremilast	Small molecule	30 mg	Oral

Indications