34617 Imsidolimab in the treatment of adult subjects with generalized pustular psoriasis: Design of a pivotal phase 3 clinical trial and a long-term extension study

Abstract

Generalized pustular psoriasis (GPP) is a debilitating, and life-threatening systemic inflammatory disease with no approved therapies in the US or EU. Treatment of recurrent flares includes use of off-label systemic immunomodulators with potentially concerning safety risks. Imsidolimab (ANB019) is a high-affinity, humanized, anti-IL-36 receptor (IL-36R) monoclonal antibody that antagonizes IL-36 cytokine signaling that is being developed to treat GPP and other inflammatory dermatoses. A Phase 3, international, multicenter, randomized, double-blind, placebo-controlled study (ANB019-301) to evaluate the efficacy and safety of imsidolimab in adult subjects with active GPP was designed and initiated following completion of an open-label, single-arm, multiple-dose Phase 2 study (NCT03619902) that demonstrated rapid resolution of pustular eruptions and systemic symptoms in subjects with GPP flare.