A Study to Test Whether Spesolimab Helps People With Generalized Pustular Psoriasis (GPP) Who Need Treatment for Repeated Flares
NCT ID: NCT06013969
Last Updated: 2025-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE4
42 participants
INTERVENTIONAL
2023-10-22
2026-08-14
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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GPP Patients
Generalized Pustular Psoriasis (GPP) patients with a recurrent flare following initial GPP flare treatment with intravenous (i.v.) spesolimab.
Spesolimab
Spesolimab intravenous (i.v.) infusion
Interventions
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Spesolimab
Spesolimab intravenous (i.v.) infusion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients must have a history of frequent GPP flares in the past
* Male or female patients, aged ≥18 years (if local legislation for age of consent differs, then local legislation will be followed) at screening
* Signed and dated written informed consent prior to admission to the trial in accordance with International Conference on Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to start of any screening procedures
* Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly
Exclusion Criteria
* Patients with primary plaque psoriasis vulgaris without presence of pustules or with pustules that are restricted to psoriatic plaques
* Patients with primary erythrodermic psoriasis vulgaris
* Patients with SAPHO (Synovitis-acne-pustulosis-hyperostosis-osteitis) syndrome
* Immediate life-threatening flare of GPP or requiring intensive care treatment, according to the investigator's judgement. Life-threatening complications mainly include, but are not limited to, cardiovascular/cytokine driven shock, pulmonary distress syndrome, or acute renal failure
* Severe, progressive, or uncontrolled hepatic disease, defined as \>3-fold upper limit normal (ULN) elevation in Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) or alkaline phosphatase, or \>2-fold ULN elevation in total bilirubin
* Presence of acute demyelinating neuropathy
* Treatment with any drug considered likely to interfere with the safe conduct of the trial, as assessed by the investigator
18 Years
ALL
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Responsible Party
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Locations
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HOP Trousseau
Chambray-lès-Tours, , France
HOP Saint-Louis
Paris, , France
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
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
Countries
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Related Links
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Related Info
Other Identifiers
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2022-502128-38-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
U1111-1291-3088
Identifier Type: REGISTRY
Identifier Source: secondary_id
1368-0120
Identifier Type: -
Identifier Source: org_study_id