Actively Recruiting
A Multi-centre, Randomised, Placebo-controlled, Double-blind Trial to Evaluate Safety and Efficacy of Spesolimab in Adults With Ulcerative Pyoderma Gangrenosum Who Need Systemic Therapy
Led by Boehringer Ingelheim · Updated on 2026-05-29
90
Participants Needed
96
Research Sites
40 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether a medicine called spesolimab can help adults with ulcerative pyoderma gangrenosum (PG), a skin condition that causes ulcers. The main goal is to see if spesolimab can lead to the complete closure of PG ulcers. This phase 3 trial includes adults with at least one ulcer measuring between 5 cm² and 80 cm², requiring systemic therapy. The study is sponsored by Boehringer Ingelheim and involves a randomized, double-blind design.
CONDITIONS
Brief 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 (or as per local consent laws) at screening
- Signed informed consent according to international and local regulations
- Confirmed diagnosis of ulcerative pyoderma gangrenosum requiring systemic therapy, verified by an Adjudication Committee
- At least one measurable PG ulcer of 5 cm² or larger, with target ulcer confirmed by an external committee
- Target ulcer diagnosed within the past 6 months, or older if active and progressing
- Women able and willing to use highly effective birth control methods with less than 1% failure rate per year
You will not qualify if you...
- Presence of non-PG skin lesions
- Target PG ulcer larger than 80 cm²
- Chronic, non-inflamed PG wounds not responsive to immunosuppressive therapy
- Active ulcer infection at screening unless treated and resolved before first dose
- Persistent or recurring bacterial infections needing systemic antibiotics, or recent significant viral, fungal, or parasitic infections within 2 weeks prior to screening
- Active tuberculosis; latent tuberculosis only if treatment started before randomization and completed during study
- Chronic or acute infections including HIV and viral hepatitis unless cured
- Severe or uncontrolled liver disease with specific enzyme or bilirubin elevations
- Additional exclusion criteria as specified by the study protocol
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 28 weeks
Participants receive Spesolimab or placebo along with systemic therapy for ulcerative pyoderma gangrenosum.
Multiple visits during treatment up to Week 28
Duration - Up to 24 weeks after treatment
Participants are monitored for recurrence and safety after treatment ends.
Visits up to Week 52 for follow-up assessments
Trial Site Locations
Total: 96 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
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
9
University of Michigan
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
10
Dartmouth Hitchcock Clinics Heater Road
Lebanon, New Hampshire, United States, 03766
Actively Recruiting
11
Dermatology at Lake Success
Lake Success, New York, United States, 11042
Actively Recruiting
12
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Actively Recruiting
13
Red River Research Partners, LLC
Fargo, North Dakota, United States, 58103
Actively Recruiting
14
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Not Yet Recruiting
15
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States, 43210
Actively Recruiting
16
Oregon Health and Sciences University
Portland, Oregon, United States, 97239
Not Yet Recruiting
17
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
18
Epiphany Dermatology
Lewisville, Texas, United States, 75056
Actively Recruiting
19
University of Utah Health MidValley Dermatology
Murray, Utah, United States, 84107
Actively Recruiting
20
CIPREC
CABA, Argentina, 1602
Completed
21
Hospital Italiano de Buenos Aires
CABA, Argentina, C1056AB
Completed
22
Instituto de Especialidades de la Salud Rosario
Rosario, Argentina, 2000
Completed
23
Skin and Cancer Foundation
Darlinghurst, New South Wales, Australia, 2010
Actively Recruiting
24
Royal North Shore Hospital-St Leonards-20807
St Leonards, New South Wales, Australia, 2065
Actively Recruiting
25
Westmead Hospital
Westmead, New South Wales, Australia, 2145
Not Yet Recruiting
26
Alfred Hospital
Melbourne, Victoria, Australia, 3004
Actively Recruiting
27
Medical University Graz
Graz, Austria, 8036
Not Yet Recruiting
28
LKH Salzburg University Hospital
Salzburg, Austria, 5020
Actively Recruiting
29
UZ Leuven
Leuven, Belgium, 3000
Actively Recruiting
30
Chronos Pesquisa Clinica
Brasília, Brazil, 72145-450
Actively Recruiting
31
Faculdade de Medicina do ABC
Santo André, Brazil, 09060-870
Not Yet Recruiting
32
Rejuvenation Dermatology Clinic
Edmonton, Alberta, Canada, T5J 3S9
Actively Recruiting
33
University of Alberta Hospital (University of Alberta)
Edmonton, Alberta, Canada, T6G 2B7
Not Yet Recruiting
34
Women's College Hospital
Toronto, Ontario, Canada, M5S 1B2
Actively Recruiting
35
McGill University Health Centre (MUHC)
Montreal, Quebec, Canada, H4A 3J1
Actively Recruiting
36
Centre de Recherche Saint-Louis
Québec, Canada, G1W 4R4
Not Yet Recruiting
37
Peking University People's Hospital
Beijing, China, 100044
Actively Recruiting
38
Peking University Third Hospital
Beijing, China, 100191
Actively Recruiting
39
The First Hospital of Jilin University
Changchun, China, 130000
Actively Recruiting
40
The Second Xiangya Hospital Of Central South University
Changsha, China, 410011
Actively Recruiting
41
West China Hospital, Sichuan University
Chengdu, China, 610041
Actively Recruiting
42
The First Affiliated Hospital, Zhejiang University
Hangzhou, China, 310003
Actively Recruiting
43
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, China, 310009
Actively Recruiting
44
Hangzhou Third People's Hospital
Hangzhou, China, 310013
Not Yet Recruiting
45
Shandong Provincial Hospital of Dermatology
Jinan, China, 250063
Actively Recruiting
46
Shanghai Skin Disease Hospital
Shanghai, China, 200000
Actively Recruiting
47
The University of Hong Kong-Shenzhen Hospital
Shenzhen, China, 518053
Actively Recruiting
48
Wuhan Union Hospital
Wuhan, China, 430022
Not Yet Recruiting
49
Second Affiliated Hospital of Xi'an JiaoTong University
Xi'an, China, 710004
Actively Recruiting
50
HUS Tulehduskeskus /Ihosairauksien linja
Helsinki, Finland, 00029
Not Yet Recruiting
51
HOP Privé Antony
Antony, France, 92160
Actively Recruiting
52
Hôpital Edouard Herriot
Lyon, France, 69437
Not Yet Recruiting
53
Hôpital de l'Archet
Nice, France, 06200
Not Yet Recruiting
54
HOP Saint-Louis
Paris, France, 75010
Not Yet Recruiting
55
Charité - Universitätsmedizin Berlin
Berlin, Germany, 10117
Not Yet Recruiting
56
Universitätsklinikum Düsseldorf
Düsseldorf, Germany, 40225
Not Yet Recruiting
57
Universitätsklinikum Erlangen
Erlangen, Germany, 91054
Actively Recruiting
58
Universitätsklinikum Essen AöR
Essen, Germany, 45147
Actively Recruiting
59
Universitätsklinikum Freiburg
Freiburg im Breisgau, Germany, 79104
Not Yet Recruiting
60
Universitätsklinikum Hamburg, Eppendorf
Hamburg, Germany, 20246
Not Yet Recruiting
61
Universitätsklinikum Tübingen
Tübingen, Germany, 72076
Not Yet Recruiting
62
Universitätsklinikum Würzburg AÖR
Würzburg, Germany, 97080
Not Yet Recruiting
63
Fondazione IRCCS Ca'Granda-Ospedale Maggiore Policlinico
Milan, Italy, 20122
Actively Recruiting
64
Azienda Ospedaliera Universitaria Pisana
Pisa, Italy, 56126
Actively Recruiting
65
Istituti Fisioterapici Ospitalieri
Roma, Italy, 00128
Actively Recruiting
66
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, Italy, 00168
Not Yet Recruiting
67
Istituto Clinico Humanitas
Rozzano (MI), Italy, 20089
Not Yet Recruiting
68
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
Torino, Italy, 10126
Not Yet Recruiting
69
Fujita Health University Hospital
Aichi, Toyoake, Japan, 470-1192
Not Yet Recruiting
70
Hokkaido University Hospital
Hokkaido, Sapporo, Japan, 060-8648
Not Yet Recruiting
71
Hyogo College of Medicine Hospital
Hyogo, Nishinomiya, Japan, 663-8501
Not Yet Recruiting
72
Mie University Hospital
Mie, Tsu, Japan, 514-8507
Actively Recruiting
73
Tohoku University Hospital
Miyagi, Sendai, Japan, 980-8574
Actively Recruiting
74
Jichi Medical University Hospital
Tochigi, Shimotsuke, Japan, 329-0498
Actively Recruiting
75
Teikyo University Hospital
Tokyo, Itabashi-ku, Japan, 173-8606
Actively Recruiting
76
Nihon University Itabashi Hospital
Tokyo, Itabashi-ku, Japan, 173-8610
Actively Recruiting
77
Hospital Raja Permaisuri Bainun
Ipoh, Malaysia, 30450
Actively Recruiting
78
Sarawak General Hospital
Kuching, Malaysia, 93586
Actively Recruiting
79
Hospital Pulau Pinang-Pulau Pinang-21953
Pulau Pinang, Malaysia, 10450
Actively Recruiting
80
Oslo Universitetssykehus HF, Rikshospitalet
Oslo, Norway, 0372
Actively Recruiting
81
Helse Stavanger, Stavanger Universitetssykehus
Stavanger, Norway, N-4011
Actively Recruiting
82
Military Medical Institute- National Research Institute
Warsaw, Poland, 04 141
Actively Recruiting
83
Cityclinic Medical and Psychological Clinic Matusiak Partnership
Wroclaw, Poland, 50-566
Actively Recruiting
84
CHUC - Centro Hospitalar e Universitário de Coimbra, EPE
Coimbra, Portugal, 3004-561
Not Yet Recruiting
85
ULS de São José, E.P.E. - Hospital Sto. António Capuchos
Lisbon, Portugal, 1169-050
Not Yet Recruiting
86
ULS de Santa Maria, E.P.E
Lisbon, Portugal, 1649-035
Actively Recruiting
87
ULS de Santo Antônio, E.P.E - Centro Hospitalar Universitário de Santo António
Porto, Portugal, 4099-001
Not Yet Recruiting
88
Hospital del Mar
Barcelona, Spain, 08003
Not Yet Recruiting
89
Hospital Universitario Ramon Y Cajal
Madrid, Spain, 28034
Actively Recruiting
90
Hospital Universitario La Paz
Madrid, Spain, 28046
Not Yet Recruiting
91
Hospital Universitario Virgen de la Victoria
Málaga, Spain, 29010
Actively Recruiting
92
Karolinska Universitetssjukhuset Solna
Stockholm, Sweden, 17176
Actively Recruiting
93
University Hospital Zurich
Zurich, Switzerland, 8091
Actively Recruiting
94
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, Taiwan, 83301
Actively Recruiting
95
Chang Gung Medical Foundation (CGMF) - Linkou Bran
Linkou District, Taiwan, 333
Actively Recruiting
96
National Taiwan University Hospital
Taipei, Taiwan, 100
Not Yet Recruiting
Research Team
B
Boehringer Ingelheim
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here