A Study to Test Whether Spesolimab Helps People With a Skin Condition Called Pyoderma Gangrenosum
Start Date
2/5/2025
Completion Date
8/19/2028
Summary
The purpose of this study is to find out whether a medicine called spesolimab helps people with pyoderma gangrenosum (PG). The main aim is to see whether spesolimab leads to closure of PG ulcers. This study is open to adults with ulcerative PG with at least 1 ulcer that measures between 5 cm\^2 to 80 cm\^2 in size. This study has 2 parts. In Part 1, participants are put into groups randomly, which means by chance. 1 group gets spesolimab and the other group gets placebo. Placebo infusions look like spesolimab infusions, but do not contain any medicine. Every participant has a 2 in 3 chance of getting spesolimab. For the first 8 weeks, participants also take corticosteroid medicine by mouth. In Part 2, participants are put into groups again. Participants without open ulcers have an equal chance of getting spesolimab or placebo. Participants with open skin ulcers will get spesolimab. In both parts, participants receive spesolimab or placebo as an infusion into a vein every 4 weeks. Participants are in the study for about 1.5 years. During this time, they visit the study site 20 times. At study visits, doctors check the participant's skin for signs of PG. The doctors also regularly check participants' health and take note of any unwanted effects. The results of the groups are compared to see whether the treatment works.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Spesolimab
Placebo matching to spesolimab
Prednisone
Prednisolone
Conditions
Locations
University of Alabama at Birmingham
Birmingham, Alabama 35233
United States
Medical Dermatology Specialists Phoenix
Phoenix, Arizona 85006
United States
University of California Irvine
Irvine, California 92697
United States
University of Miami
Miami, Florida 33136
United States
University of South Florida
Tampa, Florida 33612
United States
Advanced Medical Research PC
Sandy Springs, Georgia 30328
United States
Ada West Research
Meridian, Idaho 83646
United States
Dawes Fretzin Clinical Research Group, LLC-Indianapolis -68995
Indianapolis, Indiana 46250
United States
Tulane University Hospital and Clinic
New Orleans, Louisiana 70112
United States
Brigham and Women's Hospital
Boston, Massachusetts 02115
United States
University of Michigan
Ann Arbor, Michigan 48109
United States
Dermatology & Cosmetic Center PLLC - Flint
Flint, Michigan 48507
United States
Washington University School of Medicine
St Louis, Missouri 63110
United States
Dartmouth Hitchcock Clinics Heater Road
Lebanon, New Hampshire 03766
United States
Dermatology at Lake Success
Lake Success, New York 11042
United States
Icahn School of Medicine at Mount Sinai
New York, New York 10029
United States
Red River Research Partners, LLC
Fargo, North Dakota 58103
United States
Cleveland Clinic
Cleveland, Ohio 44195
United States
The Ohio State University Wexner Medical Center
Columbus, Ohio 43210
United States
Oregon Health and Sciences University
Portland, Oregon 97239
United States
University of Pennsylvania
Philadelphia, Pennsylvania 19104
United States
Epiphany Dermatology
Lewisville, Texas 75056
United States
University of Utah Health MidValley Dermatology
Murray, Utah 84107
United States
CIPREC
CABA, 1602
Argentina
Hospital Italiano de Buenos Aires
CABA, C1056AB
Argentina
Instituto de Especialidades de la Salud Rosario
Rosario, 2000
Argentina
Skin and Cancer Foundation
Darlinghurst, New South Wales 2010
Australia
Royal North Shore Hospital-St Leonards-20807
St Leonards, New South Wales 2065
Australia
Westmead Hospital
Westmead, New South Wales 2145
Australia
Alfred Hospital
Melbourne, Victoria 3004
Australia
Medical University of Graz
Graz, 8036
Austria
LKH Salzburg University Hospital
Salzburg, 5020
Austria
UZ Leuven
Leuven, 3000
Belgium
Chronos Pesquisa Clinica
Brasília, 72145-450
Brazil
Faculdade de Medicina do ABC
Santo André, 09060-870
Brazil
Rejuvenation Dermatology Clinic
Edmonton, Alberta T5J 3S9
Canada
University of Alberta Hospital (University of Alberta)
Edmonton, Alberta T6G 2B7
Canada
Women's College Hospital
Toronto, Ontario M5S 1B2
Canada
McGill University Health Centre (MUHC)
Montreal, Quebec H4A 3J1
Canada
Centre de Recherche Saint-Louis
Québec, G1W 4R4
Canada
Peking University People's Hospital
Beijing, 100044
China
Peking University Third Hospital
Beijing, 100191
China
The First Hospital of Jilin University
Changchun, 130000
China
The Second Xiangya Hospital Of Central South University
Changsha, 410011
China
West China Hospital, Sichuan University
Chengdu, 610041
China
The First Affiliated Hospital, Zhejiang University
Hangzhou, 310003
China
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, 310009
China
Hangzhou Third People's Hospital
Hangzhou, 310013
China
Shandong Provincial Hospital of Dermatology
Jinan, 250063
China
Shanghai Skin Disease Hospital
Shanghai, 200000
China
The University of Hong Kong-Shenzhen Hospital
Shenzhen, 518053
China
Wuhan Union Hospital
Wuhan, 430022
China
Second Affiliated Hospital of Xi'an JiaoTong University
Xi'an, 710004
China
HUS Tulehduskeskus /Ihosairauksien linja
Helsinki, 00029
Finland
HOP Privé Antony
Antony, 92160
France
Hôpital Edouard Herriot
Lyon, 69437
France
Hôpital de l'Archet
Nice, 06200
France
HOP Saint-Louis
Paris, 75010
France
Charité - Universitätsmedizin Berlin
Berlin, 10117
Germany
Universitätsklinikum Düsseldorf
Düsseldorf, 40225
Germany
Universitätsklinikum Erlangen
Erlangen, 91054
Germany
Universitätsklinikum Essen AöR
Essen, 45147
Germany
Universitätsklinikum Freiburg
Freiburg im Breisgau, 79104
Germany
Universitätsklinikum Hamburg, Eppendorf
Hamburg, 20246
Germany
Universitätsklinikum Tübingen
Tübingen, 72076
Germany
Universitätsklinikum Würzburg AÖR
Würzburg, 97080
Germany
Fondazione IRCCS Ca'Granda-Ospedale Maggiore Policlinico
Milan, 20122
Italy
Azienda Ospedaliera Universitaria Pisana
Pisa, 56126
Italy
Istituti Fisioterapici Ospitalieri
Roma, 00128
Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, 00168
Italy
Istituto Clinico Humanitas
Rozzano (MI), 20089
Italy
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
Torino, 10126
Italy
Fujita Health University Hospital
Aichi, Toyoake, 470-1192
Japan
Hokkaido University Hospital
Hokkaido, Sapporo, 060-8648
Japan
Hyogo College of Medicine Hospital
Hyogo, Nishinomiya, 663-8501
Japan
Mie University Hospital
Mie, Tsu, 514-8507
Japan
Tohoku University Hospital
Miyagi, Sendai, 980-8574
Japan
Jichi Medical University Hospital
Tochigi, Shimotsuke, 329-0498
Japan
Teikyo University Hospital
Tokyo, Itabashi-ku, 173-8606
Japan
Nihon University Itabashi Hospital
Tokyo, Itabashi-ku, 173-8610
Japan
Hospital Raja Permaisuri Bainun
Ipoh, 30450
Malaysia
Sarawak General Hospital
Kuching, 93586
Malaysia
Hospital Pulau Pinang-Pulau Pinang-21953
Pulau Pinang, 10450
Malaysia
Oslo Universitetssykehus HF, Rikshospitalet
Oslo, 0372
Norway
Helse Stavanger, Stavanger Universitetssykehus
Stavanger, N-4011
Norway
Military Medical Institute- National Research Institute
Warsaw, 04 141
Poland
Cityclinic Medical and Psychological Clinic Matusiak Partnership
Wroclaw, 50-566
Poland
CHUC - Centro Hospitalar e Universitario de Coimbra, EPE
Coimbra, 3004-561
Portugal
ULS de São José, E.P.E. - Hospital Sto. António Capuchos
Lisbon, 1169-050
Portugal
ULS de Santa Maria, E.P.E
Lisbon, 1649-035
Portugal
ULS de Santo Antônio, E.P.E - Centro Hospitalar Universitário de Santo António
Porto, 4099-001
Portugal
Hospital del Mar
Barcelona, 08003
Spain
Hospital Universitario Ramon Y Cajal
Madrid, 28034
Spain
Hospital Universitario La Paz
Madrid, 28046
Spain
Hospital Universitario Virgen de la Victoria
Málaga, 29010
Spain
Karolinska Universitetssjukhuset Solna
Stockholm, 17176
Sweden
University Hospital Zurich
Zurich, 8091
Switzerland
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, 83301
Taiwan
Chang Gung Medical Foundation (CGMF) - Linkou Bran
Linkou District, 333
Taiwan
National Taiwan University Hospital
Taipei, 100
Taiwan