This study is open to people with generalized pustular psoriasis (GPP). People can only take part if they have completed treatment in a previous study with spesolimab (1368-0013 or 1368-0027). The goal of this study is to find out how well people with GPP tolerate long-term treatment with spesolimab. The study also tests whether spesolimab helps improve GPP symptoms and how quickly the symptoms improve after a flare-up. Every participant gets spesolimab for almost 5 years (252 weeks). Depending on their symptoms and whether they had a GPP flare during the previous trial, they get spesolimab every few weeks. When participants have a GPP flare during this trial, they get spesolimab as an infusion into a vein. Participants visit their doctors regularly. During these visits, the doctors collect information on any health problems of the participants. To assess the study endpoints, doctors regularly check participants' skin.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
131
Solution for infusion
Solution for injection
Oakland Hills Dermatology
Auburn Hills, Michigan, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Hospital Italiano de Buenos Aires
CABA, Argentina
Cliniques Universitaires Saint-Luc
Brussels, Belgium
Clínica Dermacross S.A.
Vitacura, Chile
Sun yet-sen Memorial Hospital, Sun yet-sen Univesity
Occurrence of treatment emergent adverse events (TEAEs) up to week 252 of maintenance treatment
Time frame: Up to 252 Weeks
The reoccurrence of a GPP flare defined by GPPGA
The total GPPGA score ranges from 0 to 4 with a higher score indicating a higher grade of inflammation.
Time frame: Up to 252 Weeks
Time to first achievement of a GPPGA score of 0 or 1 (Patients received flare rescue Treatment)
Time frame: Up to 252 Weeks
A GPPGA pustulation sub-score of 0 indicating no visible pustules, by visit
Time frame: Up to 252 Weeks
Change from baseline in Psoriasis Symptom Scale (PSS) score, by visit
The PSS score ranges from None to Very Severe with a higher score indicating a higher severity of psoriasis symptom.
Time frame: Up to 252 Weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Guangzhou, China
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, China
Shanghai Skin Disease Hospital
Shanghai, China
Huashan Hospital, Fudan University
Shanghai, China
Second Affiliated Hospital of Xi'an JiaoTong University
Xi'an, China
...and 47 more locations