Phase 3b Safety and Efficacy Study of Apremilast to Treat Moderate to Severe Plaque-plaque Psoriasis

Summary

This study will test the clinical effectiveness and safety of apremilast compared with placebo as well as etanercept compared with placebo in the same group of patients with moderate to severe plaque psoriasis.

Timeline

Start

2012-10-01

Primary completion

2014-07-03

Completion

2016-04-04

Outcome

Met primary endpoint

paper At Week 16, PASI-75 achievement was greater with apremilast (39.8%) vs. placebo (11.9%; P < 0.0001); PMID 27768242 ↗

registry Adjusted Difference 27.5 (95% CI 14.9 to 40.1); NCT01690299 ↗

Publications

• Background Reich K, Mrowietz U, Menter A, Griffiths CEM, Bagel J, Strober B, Nunez Gomez N, Shi R, Guerette B, Lebwohl M. Effect of baseline disease severity on achievement of treatment target with apremilast: results from a pooled analysis. J Eur Acad Dermatol Venereol. 2021 Dec;35(12):2409-2414. doi: 10.1111/jdv.17520. Epub 2021 Aug 23.
• 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.
• Reich K, Gooderham M, Green L, Bewley A, Zhang Z, Khanskaya I, Day RM, Goncalves J, Shah K, Piguet V, Soung J. The efficacy and safety of apremilast, etanercept and placebo in patients with moderate-to-severe plaque psoriasis: 52-week results from a phase IIIb, randomized, placebo-controlled trial (LIBERATE). J Eur Acad Dermatol Venereol. 2017 Mar;31(3):507-517. doi: 10.1111/jdv.14015. Epub 2016 Dec 19.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Apremilast	Small molecule	30 mg	Oral
Subject	Etanercept	Protein / enzyme biologic	50 mg	—

Indications