26590 Design and rationale of Effisayil 1, a Phase II, multicenter, randomized, double-blind, placebo-controlled trial of spesolimab in patients with generalized pustular psoriasis with an acute flare

Abstract

Generalized pustular psoriasis (GPP) is a rare, potentially life-threatening disease characterized by recurrent flares of widespread skin eruptions of neutrophilic aseptic pustules that occur with or without systemic inflammation. Therapeutic intervention is a major challenge; globally, there are no approved treatments for acute GPP flares and there is a lack of robust clinical evidence to guide GPP treatment. Rapid improvements in skin symptoms with a single intravenous dose of spesolimab, an anti-IL-36 receptor antibody, was shown in a prior Phase I study.