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A Study to Test Whether Spesolimab Helps People With Generalized Pustular Psoriasis (GPP) Who Need Treatment for Repeated Flares
Sponsor: Boehringer Ingelheim
Summary
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.
Official title: Effisayil® REP:An Open-label, Multicenter, Single-arm, Post-marketing Trial (in Select Countries) to Evaluate Efficacy and Safety and the Impact of Immunogenicity on Efficacy, Safety, and Pharmacokinetics of Spesolimab i.v. in Treatment of Patients With Generalized Pustular Psoriasis (GPP) Presenting With a Recurrent Flare Following Their Initial GPP Flare Treatment With Spesolimab i.v.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
42
Start Date
2023-10-22
Completion Date
2026-08-14
Last Updated
2026-04-01
Healthy Volunteers
No
Conditions
Interventions
Spesolimab
Spesolimab intravenous (i.v.) infusion
Locations (35)
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
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
HOP Trousseau
Chambray-lès-Tours, France
HOP Saint-Louis
Paris, France
Universitätsklinikum Frankfurt
Frankfurt am Main, Germany
Klinikum der Universität München AÖR
München, Germany
SP medical college and associated group of hospitals
Bikaner, India
Nkp Salve Institute of Medical Sciences and Lata Mangeshkar Hospital
Nagpur, India
ASST degli Spedali Civili di Brescia
Brescia, Italy
Hospital Selayang
Batu Caves, Malaysia
Hospital Pulau Pinang-Pulau Pinang-21953
Georgetown Pulau Pinang, Malaysia
Hospital Sultanah Aminah
Johor Bahru, Malaysia
Hospital Sultan Ismail
Johor Bahru, Malaysia
Hospital Kuala Lumpur
Kuala Lumpur, Malaysia
Hospital Putrajaya
Putrajaya, Malaysia
Sunway Medical Centre
Selangor Darul Ehsan, Malaysia
National University Hospital-Singapore-42005
Singapore, Singapore
Nelson Mandela Academic Clinical Research Unit (NeMACRU)
Mthatha, Eastern Cape, South Africa
Seoul National University Hospital
Seoul, South Korea
Hospital Universitari Vall d'Hebron
Barcelona, Spain
Hospital Universitario Ramon Y Cajal
Madrid, Spain
National Taiwan University Hospital
Taipei, Taiwan
Chang Gung Memorial Hospital, Linkou
Taoyuan District, Taiwan
Srinagarind Hospital
Khon Kaen, Thailand
Maharat Nakhonchiangmai Hospital
Muang Chiang Mai, Thailand
Hedi Chaker Hospital, Department of Dermatology
Sfax, Tunisia
Farhat Hached Hospital
Sousse, Tunisia