Efficacy and Safety Study of Apremilast in Subjects With Moderate to Severe Atopic Dermatitis

NCT02087943 ↗

Phase 2 Completed 191 enrolled Amgen

RandomizedParallel-groupTriple-blindTreatment

Summary

A study to evaluate the efficacy and safety of apremilast (CC-10004) in subjects with moderate to severe atopic dermatitis

Timeline

Start: 2014-06
Primary completion: 2015-10
Completion: 2016-02

Outcome

Mixed primary results

registry analysis (unspecified test); Placebo vs Apremilast 40 mg; p = 0.0347; LS Mean Difference -20.60 (95% CI -39.70 to -1.50); ANCOVA NCT02087943 ↗

paper APR40 (n = 63), but not APR30 (n = 58), led to statistically significant improvements (vs. placebo, n = 64) in Eczema Area and Severity Index PMID 30528828 ↗

registry EASI score ranges from 0 to 72. A higher score indicated worse disease status, and a negative change from baseline indicated improvement. NCT02087943 ↗

Publications

Simpson EL, Imafuku S, Poulin Y, Ungar B, Zhou L, Malik K, Wen HC, Xu H, Estrada YD, Peng X, Chen M, Shah N, Suarez-Farinas M, Pavel AB, Nograles K, Guttman-Yassky E. A Phase 2 Randomized Trial of Apremilast in Patients with Atopic Dermatitis. J Invest Dermatol. 2019 May;139(5):1063-1072. doi: 10.1016/j.jid.2018.10.043. Epub 2018 Dec 5.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Apremilast	Small molecule	30 mg	Oral
Subject	Apremilast	Small molecule	40 mg	Oral