Study protocol of the global Effisayil 1 Phase II, multicentre, randomised, double-blind, placebo-controlled trial of spesolimab in patients with generalized pustular psoriasis presenting with an acute flare

• Published in: BMJ open Vol. 11; no. 3; p. e043666
• Main Authors: Choon, Siew Eng, Lebwohl, Mark G, Marrakchi, Slaheddine, Burden, A David, Tsai, Tsen-Fang, Morita, Akimichi, Navarini, Alexander A, Zheng, Min, Xu, Jinhua, Turki, Hamida, Rajeswari, Sushmita, Deng, Hongjie, Tetzlaff, Kay, Thoma, Christian, Bachelez, Hervé
• Format: Journal Article
• Language: English
• Published: England British Medical Journal Publishing Group 30.03.2021; BMJ Publishing Group LTD; BMJ Publishing Group
• Series: Protocol
• Subjects: clinical trials; Cytokines; Dermatology; dermatopathology; Disease; Double-blind studies; Erythema; Inflammation; Monoclonal antibodies; Mutation; Psoriasis; TNF inhibitors; Tumor necrosis factor-TNF; Thailand; Japan; Taiwan; dermatopathology; psoriasis; clinical trials

IntroductionGeneralized pustular psoriasis (GPP) is a rare, potentially life-threatening disease characterised by recurrent flares of widespread neutrophilic aseptic skin pustular eruption. Despite the availability of approved biologics for GPP in Japan, Taiwan and Thailand, associated evidence is l...