Phase
Condition
Warts
Skin Wounds
Psoriasis And Psoriatic Disorders
Treatment
Spesolimab
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Patients with a Generalized Pustular Psoriasis Physician Global Assessment (GPPGA)pustulation sub-score of 0 or 1 and a known and documented history of GeneralizedPustular Psoriasis (GPP) (per European Rare And Severe Psoriasis Expert Network -ERASPEN - criteria), regardless of Interleukin 36 Receptor Antagonist (IL-36RN) genemutation status or Patients with a GPP flare and a known and documented history ofGPP (per ERASPEN criteria) regardless of IL-36RN gene mutation status.
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 consentdiffers, then local legislation will be followed) at screening
Signed and dated written informed consent prior to admission to the trial inaccordance 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 highlyeffective methods of birth control per ICH M3 (R2) that result in a low failure rateof less than 1% per year when used consistently and correctly
Exclusion
Exclusion Criteria:
Drug-triggered Acute Generalized Exanthematous Pustulosis (AGEP)
Patients with primary plaque psoriasis vulgaris without presence of pustules or withpustules 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 mainlyinclude, but are not limited to, cardiovascular/cytokine driven shock, pulmonarydistress syndrome, or acute renal failure
Severe, progressive, or uncontrolled hepatic disease, defined as >3-fold upper limitnormal (ULN) elevation in Aspartate Aminotransferase (AST) or AlanineAminotransferase (ALT) or alkaline phosphatase, or >2-fold ULN elevation in totalbilirubin
Presence of acute demyelinating neuropathy
Treatment with any drug considered likely to interfere with the safe conduct of thetrial, as assessed by the investigator
Further exclusion criteria apply.
Study Design
Connect with a study center
Liverpool Hospital
Liverpool, New South Wales 2170
AustraliaSite Not Available
Westmead Hospital
Westmead, New South Wales 2145
AustraliaSite Not Available
Brussels - UNIV Saint-Luc
Bruxelles, 1200
BelgiumSite Not Available
Hospital Universitario Evangelico Mackenzie
Curitiba, 80440-220
BrazilSite Not Available
Faculdade de Medicina do ABC
Santo André, 09060-870
BrazilSite Not Available
Southern Medical University Dermatology Hospital
Guangzhou, 510091
ChinaSite Not Available
Shandong Provincial Hospital of Dermatology
Jinan, 250063
ChinaSite Not Available
Shanghai Skin Disease Hospital
Shanghai, 200000
ChinaSite Not Available
Shanghai Tenth People's Hospital
Shanghai, 200072
ChinaSite Not Available
Second Affiliated Hospital of Xi'an JiaoTong University
Xi'an, 710004
ChinaSite Not Available
HOP Trousseau
Chambray-lès-Tours, 37170
FranceSite Not Available
HOP François Mitterrand
Dijon, 21079
FranceSite Not Available
HOP Saint-Louis
Paris, 75010
FranceSite Not Available
Universitätsklinikum Frankfurt
Frankfurt am Main, 60596
GermanySite Not Available
Klinikum der Universität München AÖR
München, 80337
GermanySite Not Available
SP medical college and associated group of hospitals
Bikaner, 334003
IndiaSite Not Available
Kasturba Medical College and Hospital
Manipal, 576104
IndiaSite Not Available
Nkp Salve Institute of Medical Sciences and Lata Mangeshkar Hospital
Nagpur, 440019
IndiaSite Not Available
ASST degli Spedali Civili di Brescia
Brescia, 25123
ItalySite Not Available
Presidio Ospedaliero Palagi
Firenze, 50125
ItalySite Not Available
AOU Università degli Studi della Campania Luigi Vanvitelli
Napoli, 80131
ItalySite Not Available
Fondazione Policlinico Universitario Agostino Gemelli
Roma, 00168
ItalySite Not Available
Pusan National Univ. Hosp
Busan, 602-739
Korea, Republic ofSite Not Available
Seoul National University Hospital
Seoul, 03080
Korea, Republic ofSite Not Available
Severance Hospital
Seoul, 03722
Korea, Republic ofSite Not Available
Hospital Selayang
Batu Caves, 68100
MalaysiaSite Not Available
Hospital Pulau Pinang
Georgetown Pulau Pinang, 10990
MalaysiaSite Not Available
Hospital Pulau Pinang-Pulau Pinang-21953
Georgetown Pulau Pinang, 10990
MalaysiaSite Not Available
Hospital Raja Permaisuri Bainun
Ipoh, 30450
MalaysiaSite Not Available
Hospital Sultan Ismail
Johor Bahru, 81100
MalaysiaSite Not Available
Hospital Sultanah Aminah
Johor Bahru, 80100
MalaysiaSite Not Available
Hospital Raja Perempuan Zainab II, Kota Bharu
Kota Bharu, 15200
MalaysiaSite Not Available
Queen Elizabeth Hospital
Kota Kinabalu, 88586
MalaysiaSite Not Available
Hospital Kuala Lumpur
Kuala Lumpur, 50586
MalaysiaSite Not Available
Hospital Putrajaya
Putrajaya, 62250
MalaysiaSite Not Available
Sunway Medical Centre
Selangor Darul Ehsan, 47500
MalaysiaSite Not Available
Changi General Hospital
Singapore, 529889
SingaporeActive - Recruiting
National University Hospital
Singapore, 119228
SingaporeSite Not Available
Nelson Mandela Academic Clinical Research Unit (NeMACRU)
Mthatha, Eastern Cape, 5099
South AfricaSite Not Available
Hospital Vall d'Hebron
Barcelona, 08035
SpainSite Not Available
Hospital Vall d'Hebron-Barcelona-47683
Barcelona, 08035
SpainSite Not Available
Hospital Ramón y Cajal
Madrid, 28034
SpainSite Not Available
National Taiwan University Hospital
Taipei, 100
TaiwanSite Not Available
Chang Gung Memorial Hospital(Linkou)
Taoyuan, 330
TaiwanSite Not Available
Srinagarind Hospital
Khon Kaen, 40000
ThailandSite Not Available
Maharat Nakhonchiangmai Hospital
Muang Chiang Mai, 50200
ThailandSite Not Available
Hedi Chaker Hospital, Department of Dermatology
Sfax, 1053
TunisiaSite Not Available
Farhat Hached Hospital
Sousse, 4000
TunisiaSite Not Available
La Rabta Hospital
Tunis, 1007
TunisiaSite Not Available
Gazi University Medical Faculty
Ankara, 06500
TurkeySite Not Available
University of California Irvine
Irvine, California 92697
United StatesSite Not Available
Oakland Hills Dermatology, PC
Auburn Hills, Michigan 48326
United StatesSite Not Available
AXIS Clinicals
Fargo, North Dakota 58103
United StatesSite Not Available
Red River Research Partners, LLC
Fargo, North Dakota 58103
United StatesSite Not Available
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