Approximately 250 male and female subjects, aged 18 to 70 years (inclusive) will be enrolled in this study. Subjects will be randomized to receive either one of the four doses of NDI-034858, or placebo on Day 1. The goal is to have approximately 50 subjects randomized per treatment group (1:1:1:1:1 ratio) on Day 1. During the treatment period, NDI-034858 or placebo will be orally administered QD for 12 weeks. The 12 week treatment period will be followed by a 4-week safety follow-up period.
This is a Phase 2b, randomized, multicenter, double-blind, placebo-controlled, multiple-dose study designed to evaluate the efficacy, safety, and tolerability of NDI-034858 in subjects with moderate to severe plaque psoriasis. This study will also evaluate the plasma concentrations of NDI-034858 and explore the immune response to NDI-034858 in subjects with moderate to severe plaque psoriasis.