Actively Recruiting
A Study to Test Whether Spesolimab Helps People With a Skin Condition Called Pyoderma Gangrenosum
Led by Boehringer Ingelheim · Updated on 2026-05-13
90
Participants Needed
97
Research Sites
184 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study to Test Whether Spesolimab Helps People With a Skin Condition Called Pyoderma Gangrenosum
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older at screening
- Signed written informed consent before joining the study
- Confirmed diagnosis of ulcerative pyoderma gangrenosum (PG) requiring systemic therapy
- At least one measurable PG ulcer of 5 cm² or larger
- Target ulcer diagnosed within the past 6 months, or if older than 6 months, it must be active and progressing
- Women able and willing to use highly effective birth control methods
You will not qualify if you...
- Presence of lesions that are not PG
- Target PG ulcer larger than 80 cm²
- Chronic non-inflamed PG wounds not responding to immunosuppressive therapy
- Active ulcer infection at screening unless treated and resolved before treatment
- Persistent or recurring bacterial infection needing systemic antibiotics or recent viral, fungal, or parasitic infections within 2 weeks prior to screening
- Active tuberculosis (TB)
- Severe liver disease with specific enzyme elevations
- Chronic or acute infections including HIV and viral hepatitis
- Other further exclusion criteria as specified by the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 97 locations
1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
Actively Recruiting
2
Medical Dermatology Specialists Phoenix
Phoenix, Arizona, United States, 85006
Actively Recruiting
3
University of California Irvine
Irvine, California, United States, 92697
Actively Recruiting
4
University of Miami
Miami, Florida, United States, 33136
Actively Recruiting
5
University of South Florida
Tampa, Florida, United States, 33612
Actively Recruiting
6
Ada West Research
Meridian, Idaho, United States, 83646
Not Yet Recruiting
7
Dawes Fretzin Clinical Research Group, LLC-Indianapolis -68995
Indianapolis, Indiana, United States, 46250
Actively Recruiting
8
Tulane University Hospital and Clinic
New Orleans, Louisiana, United States, 70112
Not Yet Recruiting
9
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
10
University of Michigan
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
11
Dartmouth Hitchcock Clinics Heater Road
Lebanon, New Hampshire, United States, 03766
Actively Recruiting
12
Dermatology at Lake Success
Lake Success, New York, United States, 11042
Actively Recruiting
13
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Actively Recruiting
14
Red River Research Partners, LLC
Fargo, North Dakota, United States, 58103
Actively Recruiting
15
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Not Yet Recruiting
16
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States, 43210
Actively Recruiting
17
Oregon Health and Sciences University
Portland, Oregon, United States, 97239
Not Yet Recruiting
18
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
19
Epiphany Dermatology
Lewisville, Texas, United States, 75056
Actively Recruiting
20
University of Utah Health MidValley Dermatology
Murray, Utah, United States, 84107
Actively Recruiting
21
CIPREC
CABA, Argentina, 1602
Completed
22
Hospital Italiano de Buenos Aires
CABA, Argentina, C1056AB
Completed
23
Instituto de Especialidades de la Salud Rosario
Rosario, Argentina, 2000
Completed
24
Skin and Cancer Foundation
Darlinghurst, New South Wales, Australia, 2010
Actively Recruiting
25
Royal North Shore Hospital-St Leonards-20807
St Leonards, New South Wales, Australia, 2065
Actively Recruiting
26
Westmead Hospital
Westmead, New South Wales, Australia, 2145
Not Yet Recruiting
27
Alfred Hospital
Melbourne, Victoria, Australia, 3004
Actively Recruiting
28
Medical University Graz
Graz, Austria, 8036
Not Yet Recruiting
29
LKH Salzburg University Hospital
Salzburg, Austria, 5020
Actively Recruiting
30
UZ Leuven
Leuven, Belgium, 3000
Actively Recruiting
31
Chronos Pesquisa Clinica
Brasília, Brazil, 72145-450
Actively Recruiting
32
Faculdade de Medicina do ABC
Santo André, Brazil, 09060-870
Not Yet Recruiting
33
Rejuvenation Dermatology Clinic
Edmonton, Alberta, Canada, T5J 3S9
Actively Recruiting
34
University of Alberta Hospital (University of Alberta)
Edmonton, Alberta, Canada, T6G 2B7
Not Yet Recruiting
35
Women's College Hospital
Toronto, Ontario, Canada, M5S 1B2
Actively Recruiting
36
McGill University Health Centre (MUHC)
Montreal, Quebec, Canada, H4A 3J1
Actively Recruiting
37
Centre de Recherche Saint-Louis
Québec, Canada, G1W 4R4
Not Yet Recruiting
38
Peking University People's Hospital
Beijing, China, 100044
Actively Recruiting
39
Peking University Third Hospital
Beijing, China, 100191
Actively Recruiting
40
The First Hospital of Jilin University
Changchun, China, 130000
Actively Recruiting
41
The Second Xiangya Hospital Of Central South University
Changsha, China, 410011
Actively Recruiting
42
West China Hospital, Sichuan University
Chengdu, China, 610041
Actively Recruiting
43
The First Affiliated Hospital, Zhejiang University
Hangzhou, China, 310003
Actively Recruiting
44
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, China, 310009
Actively Recruiting
45
Hangzhou Third People's Hospital
Hangzhou, China, 310013
Not Yet Recruiting
46
Shandong Provincial Hospital of Dermatology
Jinan, China, 250063
Actively Recruiting
47
Shanghai Skin Disease Hospital
Shanghai, China, 200000
Actively Recruiting
48
The University of Hong Kong-Shenzhen Hospital
Shenzhen, China, 518053
Actively Recruiting
49
Wuhan Union Hospital
Wuhan, China, 430022
Not Yet Recruiting
50
Second Affiliated Hospital of Xi'an JiaoTong University
Xi'an, China, 710004
Actively Recruiting
51
HUS Tulehduskeskus /Ihosairauksien linja
Helsinki, Finland, 00029
Not Yet Recruiting
52
HOP Privé Antony
Antony, France, 92160
Actively Recruiting
53
Hôpital Edouard Herriot
Lyon, France, 69437
Not Yet Recruiting
54
Hôpital de l'Archet
Nice, France, 06200
Not Yet Recruiting
55
HOP Saint-Louis
Paris, France, 75010
Not Yet Recruiting
56
Charité - Universitätsmedizin Berlin
Berlin, Germany, 10117
Not Yet Recruiting
57
Universitätsklinikum Düsseldorf
Düsseldorf, Germany, 40225
Not Yet Recruiting
58
Universitätsklinikum Erlangen
Erlangen, Germany, 91054
Actively Recruiting
59
Universitätsklinikum Essen AöR
Essen, Germany, 45147
Actively Recruiting
60
Universitätsklinikum Freiburg
Freiburg im Breisgau, Germany, 79104
Not Yet Recruiting
61
Universitätsklinikum Hamburg, Eppendorf
Hamburg, Germany, 20246
Not Yet Recruiting
62
Universitätsklinikum Tübingen
Tübingen, Germany, 72076
Not Yet Recruiting
63
Universitätsklinikum Würzburg AÖR
Würzburg, Germany, 97080
Not Yet Recruiting
64
Fondazione IRCCS Ca'Granda-Ospedale Maggiore Policlinico
Milan, Italy, 20122
Actively Recruiting
65
Azienda Ospedaliera Universitaria Pisana
Pisa, Italy, 56126
Actively Recruiting
66
Istituti Fisioterapici Ospitalieri
Roma, Italy, 00128
Actively Recruiting
67
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, Italy, 00168
Not Yet Recruiting
68
Istituto Clinico Humanitas
Rozzano (MI), Italy, 20089
Not Yet Recruiting
69
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
Torino, Italy, 10126
Not Yet Recruiting
70
Fujita Health University Hospital
Aichi, Toyoake, Japan, 470-1192
Not Yet Recruiting
71
Hokkaido University Hospital
Hokkaido, Sapporo, Japan, 060-8648
Not Yet Recruiting
72
Hyogo College of Medicine Hospital
Hyogo, Nishinomiya, Japan, 663-8501
Not Yet Recruiting
73
Mie University Hospital
Mie, Tsu, Japan, 514-8507
Actively Recruiting
74
Tohoku University Hospital
Miyagi, Sendai, Japan, 980-8574
Actively Recruiting
75
Jichi Medical University Hospital
Tochigi, Shimotsuke, Japan, 329-0498
Actively Recruiting
76
Teikyo University Hospital
Tokyo, Itabashi-ku, Japan, 173-8606
Actively Recruiting
77
Nihon University Itabashi Hospital
Tokyo, Itabashi-ku, Japan, 173-8610
Actively Recruiting
78
Hospital Raja Permaisuri Bainun
Ipoh, Malaysia, 30450
Actively Recruiting
79
Sarawak General Hospital
Kuching, Malaysia, 93586
Actively Recruiting
80
Hospital Pulau Pinang-Pulau Pinang-21953
Pulau Pinang, Malaysia, 10450
Actively Recruiting
81
Oslo Universitetssykehus HF, Rikshospitalet
Oslo, Norway, 0372
Actively Recruiting
82
Helse Stavanger, Stavanger Universitetssykehus
Stavanger, Norway, N-4011
Actively Recruiting
83
Military Medical Institute- National Research Institute
Warsaw, Poland, 04 141
Actively Recruiting
84
Cityclinic Medical and Psychological Clinic Matusiak Partnership
Wroclaw, Poland, 50-566
Actively Recruiting
85
CHUC - Centro Hospitalar e Universitário de Coimbra, EPE
Coimbra, Portugal, 3004-561
Not Yet Recruiting
86
ULS de São José, E.P.E. - Hospital Sto. António Capuchos
Lisbon, Portugal, 1169-050
Not Yet Recruiting
87
ULS de Santa Maria, E.P.E
Lisbon, Portugal, 1649-035
Actively Recruiting
88
ULS de Santo Antônio, E.P.E - Centro Hospitalar Universitário de Santo António
Porto, Portugal, 4099-001
Not Yet Recruiting
89
Hospital del Mar
Barcelona, Spain, 08003
Not Yet Recruiting
90
Hospital Universitario Ramon Y Cajal
Madrid, Spain, 28034
Actively Recruiting
91
Hospital Universitario La Paz
Madrid, Spain, 28046
Not Yet Recruiting
92
Hospital Universitario Virgen de la Victoria
Málaga, Spain, 29010
Actively Recruiting
93
Karolinska Universitetssjukhuset Solna
Stockholm, Sweden, 17176
Actively Recruiting
94
University Hospital Zurich
Zurich, Switzerland, 8091
Actively Recruiting
95
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, Taiwan, 83301
Actively Recruiting
96
Chang Gung Medical Foundation (CGMF) - Linkou Bran
Linkou District, Taiwan, 333
Actively Recruiting
97
National Taiwan University Hospital
Taipei, Taiwan, 100
Not Yet Recruiting
Research Team
B
Boehringer Ingelheim
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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