Apremilast as a Direct Treatment for Mild-to-moderate Plaque Psoriasis Versus Placebo: an Analysis of Clinical Safety and Efficacy

Summary

This is a Phase 3, multicenter, randomized, placebo-controlled, double-blind study designed to evaluate the efficacy and safety of apremilast (CC-10004) in subjects with mild to moderate plaque psoriasis. Approximately 574 subjects with mild to moderate plaque psoriasis will be randomized 1:1 to receive either apremilast 30 mg BID or placebo for the first 16 weeks.

Timeline

Start

2019-03-11

Primary completion

2020-03-06

Completion

2020-07-24

Outcome

Met primary endpoint

registry analysis (superiority test); Placebo-controlled Phase: Placebo vs Placebo-controlled Phase: Apremilast 30 mg; p <0.0001; Adjusted difference 17.5 (95% CI 12.2 to 22.8); Cochran-Mantel-Haenszel NCT03721172 ↗

release “In May, the Phase 3 ADVANCE study in patients with mild to moderate psoriasis met its primary endpoint and all secondary endpoints at week 16.” amgen.com ↗

release “In ADVANCE, oral Otezla 30 mg twice daily achieved a statistically significant improvement of the primary endpoint” amgen.com ↗

Publications

• Background Stein Gold L, Papp K, Pariser D, Green L, Bhatia N, Sofen H, Albrecht L, Gooderham M, Chen M, Paris M, Wang Y, Callis Duffin K. Efficacy and safety of apremilast in patients with mild-to-moderate plaque psoriasis: Results of a phase 3, multicenter, randomized, double-blind, placebo-controlled trial. J Am Acad Dermatol. 2022 Jan;86(1):77-85. doi: 10.1016/j.jaad.2021.07.040. Epub 2021 Jul 31.
• Background 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	30 mg	Oral

Indications