A Study to Determine the Efficacy of ZPL-3893787 in Subjects With Atopic Dermatitis

Summary

This was a randomized, double blind, placebo controlled, parallel group study in approximately 90 subjects with moderate-severe AD Eczema Area and Severity Index (EASI) ≥12 and ≤ 48 (0-72 scale). Following a run-in subjects were randomized to receive either oral 30 mg ZPL-3893787 once daily (od) or placebo od for 8 weeks (56 days).

Timeline

Start

2015-05-18

Primary completion

2016-01

Completion

2016-02-03

Outcome

Missed primary endpoint

registry analysis (superiority test); ZPL-3893787 vs Placebo; p = 0.249; LS Difference -0.35 (90% CI -1.21 to 0.51); ANCOVA; note: 1-sided p-value. NCT02424253 ↗

Drugs

Indications