This study is open to adults with a serious skin disease called generalized pustular psoriasis (GPP) who have repeated flares of GPP. The purpose of this study is to find out whether a medicine called spesolimab helps people with repeated flares of GPP. Participants are given a single dose of spesolimab as an infusion into a vein on the first day of an outbreak of GPP. They may be given a second dose 1 week later if doctors think it is helpful. They are also treated for additional GPP flares. During the time of the study, doctors regularly examine participants' skin for signs of GPP to see how well the treatment works and take blood samples. The doctors also regularly check participants' health and take note of any unwanted effects.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
42
Spesolimab intravenous (i.v.) infusion
University of California Irvine
Irvine, California, United States
Red River Research Partners, LLC
Fargo, North Dakota, United States
Liverpool Hospital
Liverpool, New South Wales, Australia
Westmead Hospital
Westmead, New South Wales, Australia
Cliniques Universitaires Saint-Luc
Brussels, Belgium
Achievement of a Generalized Pustular Psoriasis Physician Global Assessment (GPPGA) pustulation sub-score of 0 indicating no visible pustules at Week 1
Time frame: Up to week 1
Achievement of a GPPGA pustulation sub-score of 0 or 1, with a ≥2-point reduction from baseline at Week 1
Time frame: Up to week 1
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Hospital Universitario Evangelico Mackenzie
Curitiba, Brazil
Faculdade de Medicina do ABC
Santo André, Brazil
Southern Medical University Dermatology Hospital
Guangzhou, China
Shanghai Skin Disease Hospital
Shanghai, China
Shanghai Tenth People's Hospital
Shanghai, China
...and 25 more locations