An Efficacy and Safety Study of Apremilast (CC-10004) in Subjects With Moderate to Severe Genital Psoriasis

Summary

This Phase 3 multicenter, randomized, placebo-controlled, double-blind study is designed to evaluate the efficacy and safety of apremilast in subjects with moderate to severe genital psoriasis (modified sPGA-G ≥3, moderate or severe). Approximately 286 subjects with moderate to severe genital psoriasis will be randomized 1:1 to receive either apremilast 30 mg BID or placebo for the first 16 weeks.

Timeline

Start

2019-02-11

Primary completion

2021-09-23

Completion

2022-02-09

Publications

• Background Merola JF, Parish LC, Guenther L, Lynde C, Lacour JP, Staubach P, Cheng S, Paris M, Picard H, Deignan C, Jardon S, Chen M, Papp KA. Efficacy and safety of apremilast in patients with moderate-to-severe genital psoriasis: Results from DISCREET, a phase 3 randomized, double-blind, placebo-controlled trial. J Am Acad Dermatol. 2024 Mar;90(3):485-493. doi: 10.1016/j.jaad.2023.10.020. Epub 2023 Oct 16.
• Merola JF, Guenther L, Lynde C, Papp KA, Parish LC, Yamauchi P, Cheng S, Amouzadeh H, Deignan C, Jardon S, Chen M, Pinter A. Results from the 32-week, phase 3 DISCREET study of apremilast in patients with moderate to severe genital psoriasis. J Eur Acad Dermatol Venereol. 2026 Feb;40(2):274-284. doi: 10.1111/jdv.70110. Epub 2025 Dec 10.

Drugs

Indications