434 The study design of two trials of dupilumab in patients with prurigo nodularis inadequately controlled with topical therapies: LIBERTY PN PRIME and PRIME 2

Abstract

Multiple case series suggest dupilumab should be studied further in patients with prurigo nodularis (PN). We describe the study design of two phase 3 trials to assess if dupilumab can improve itch and resolve PN lesions. PRIME (NCT04183335) and PRIME2 (NCT04202679) are 2 double-blind, placebo-controlled, multicenter, parallel-group studies consisting of 2–4 weeks screening, 24 weeks randomized treatment with dupilumab or placebo, and 12 weeks follow-up. Low-/medium-potency topical corticosteroids (TCS)/topical calcineurin inhibitors are permitted.