A Study to Test Whether Spesolimab Helps People With a Skin Condition Called Pyoderma Gangrenosum
A Multi-centre, Randomised, Placebo-controlled, Double-blind, Parallel-group Trial to Evaluate Safety and Efficacy of Spesolimab (BI 655130) in Adult Patients With Ulcerative Pyoderma Gangrenosum (PG) Who Require Systemic Therapy
3 other identifiers
interventional
90
20 countries
92
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Feb 2025
Typical duration for phase_3
92 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 30, 2024
CompletedFirst Posted
Study publicly available on registry
October 3, 2024
CompletedStudy Start
First participant enrolled
February 4, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 12, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 19, 2028
April 29, 2026
April 1, 2026
2.8 years
September 30, 2024
April 28, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Achievement of complete closure (PGAR-100 (100% pyoderma gangrenosum area reduction)) of the target PG ulcer at any time up to Week 26 and confirmed at the next consecutive visit (at least 2 weeks later)
PGAR-100 is defined as complete closure and re-epithelisation of a PG ulcer without drainage and requirements for dressing.
Up to Week 28.
Secondary Outcomes (8)
Key secondary endpoint: Achievement of PGAR-100 of the target PG ulcer at Week 26 confirmed at the next consecutive visit (at least 2 weeks later)
Up to Week 28.
Achievement of 50% area reduction (PGAR-50) of the target PG ulcer at any time up to Week 26
Up to Week 26.
Achievement of ≥ 3 point reduction in NRS Pain score from baseline at Week 26
At baseline and at Week 26.
Achievement of a DLQI of ≤ 5 at Week 26
At Week 26.
Achievement of complete response
At Week 26.
- +3 more secondary outcomes
Study Arms (2)
Spesolimab
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Adult trial participants, 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 in accordance with International Council on Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial.
- A confirmed diagnosis of ulcerative pyoderma gangrenosum (PG) (≥10 points on the PARACELSUS score) that requires systemic therapy in the opinion of the investigator. The diagnosis needs to be confirmed by an Adjudication Committee. Trial participants with mixed PG subtypes are eligible as long as the target lesion is of the ulcerative subtype.
- At least one measurable (defined as measuring ≥5 cm\^2) PG ulcer. In trial participants with more than one PG ulcer, the target PG ulcer will be selected by the investigator and confirmed by external Adjudication Committee.
- At the time of the Screening Visit, a maximum duration of 6 months since the target ulcer in the current PG episode was diagnosed. Target ulcers \>6 months since diagnosis are allowed if they are active and progressing, as judged by the investigator and confirmed by an Adjudication Committee.
- 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. A list of contraception methods meeting these criteria and instructions on the duration of use is provided in the participant information and in the protocol.
You may not qualify if:
- Trial participants with non-PG lesions.
- Trial participants with a target PG ulcer measuring \>80 cm\^2.
- Trial participants with chronic, non-inflamed PG wounds or ulcers that are not responsive to immunosuppressive therapy, as determined by an Adjudication Committee.
- Presence of active ulcer infection at the Screening Visit (unless treated and resolved prior to administration of the first dose of trial medication) based on investigator assessment.
- Presence of persistent or recurring bacterial infection requiring systemic antibiotic therapy; or clinically significant viral, fungal, or parasitic infections within 2 weeks prior to the Screening Visit. Any such infection must be resolved, with treatment completed ≥2 weeks prior to the Screening Visit. No new/recurrent infections should have occurred prior to Visit 2.
- "Active or latent tuberculosis (TB)
- Participants with active TB are excluded
- Participants with latent TB may be included if treatment of latent TB, as per local guidelines, is initiated prior to randomization and completed during the course of the trial."
- Chronic or acute infections including Human immunodeficiency virus (HIV) infections and viral hepatitis (including occult hepatitis); the corresponding laboratory tests will be performed during screening. A trial participant can be re-screened if the trial participant was treated and is cured from the acute infection.
- Severe, progressive, or uncontrolled hepatic disease, defined as \>3x Upper Limit of Normal (ULN) elevation in Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) or alkaline phosphatase, or \>2x ULN elevation in total bilirubin.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (96)
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
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
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 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 Universitário 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
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 30, 2024
First Posted
October 3, 2024
Study Start
February 4, 2025
Primary Completion (Estimated)
November 12, 2027
Study Completion (Estimated)
August 19, 2028
Last Updated
April 29, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share
Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datatransparency