A Study to Test Whether Spesolimab Helps People With a Skin Condition Called Pyoderma Gangrenosum
NCT ID: NCT06624670
Last Updated: 2025-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
90 participants
INTERVENTIONAL
2025-02-04
2028-02-01
Brief Summary
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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 injections look like spesolimab injections, 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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Spesolimab
Spesolimab
Solution for infusion
Prednisone
Prednisone
Prednisolone
Prednisolone
Placebo
Placebo matching to spesolimab
Placebo matching to spesolimab
Prednisone
Prednisone
Prednisolone
Prednisolone
Interventions
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Spesolimab
Solution for infusion
Placebo matching to spesolimab
Placebo matching to spesolimab
Prednisone
Prednisone
Prednisolone
Prednisolone
Eligibility Criteria
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Inclusion Criteria
2. 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.
3. 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.
4. 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.
5. 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.
6. 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.
Exclusion Criteria
2. Trial participants with a target PG ulcer measuring \>80 cm\^2.
3. Trial participants with chronic, non-inflamed PG wounds or ulcers that are not responsive to immunosuppressive therapy, as determined by an Adjudication Committee.
4. 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.
5. 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.
6. "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."
7. 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.
8. 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.
18 Years
ALL
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Responsible Party
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Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Medical Dermatology Specialists Phoenix
Phoenix, Arizona, United States
University of California Irvine
Irvine, California, United States
University of Miami
Miami, Florida, United States
University of South Florida
Tampa, Florida, United States
Dawes Fretzin Clinical Research Group, LLC-Indianapolis -68995
Indianapolis, Indiana, United States
Tulane University Hospital and Clinic
New Orleans, Louisiana, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
University of Michigan Health System
Ann Arbor, Michigan, United States
Dartmouth Hitchcock Clinics Heater Road
Lebanon, New Hampshire, United States
Dermatology at Lake Success
Lake Success, New York, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Red River Research Partners, LLC
Fargo, North Dakota, United States
Cleveland Clinic
Cleveland, Ohio, United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States
Oregon Health and Sciences University
Portland, Oregon, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Epiphany Dermatology
Lewisville, Texas, United States
CIPREC
CABA, , Argentina
Hospital Italiano de Buenos Aires
CABA, , Argentina
Instituto de Especialidades de la Salud Rosario
Rosario, , Argentina
Skin and Cancer Foundation
Darlinghurst, New South Wales, Australia
Royal North Shore Hospital-St Leonards-20807
St Leonards, New South Wales, Australia
Alfred Hospital
Melbourne, Victoria, Australia
Medical University of Graz State Hospital - University Hospital Graz
Graz, , Austria
LKH Salzburg University Hospital
Salzburg, , Austria
UZ Leuven
Leuven, , Belgium
Chronos Pesquisa Clinica
Brasília, , Brazil
Faculdade de Medicina do ABC
Santo André, , Brazil
Rejuvenation Dermatology Clinic
Edmonton, Alberta, Canada
University of Alberta Hospital (University of Alberta)
Edmonton, Alberta, Canada
Women's College Hospital
Toronto, Ontario, Canada
McGill University Health Centre (MUHC)
Montreal, Quebec, Canada
Centre de Recherche Saint-Louis
Québec, , Canada
Peking University People's Hospital
Beijing, , China
Peking University Third Hospital
Beijing, , China
The First Hospital of Jilin University
Changchun, , China
The Second Xiangya Hospital Of Central South University
Changsha, , China
West China Hospital of Sichuan University
Chengdu, , China
The First Affiliated Hospital, Zhejiang University
Hangzhou, , China
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, , China
Hangzhou Third People's Hospital
Hangzhou, , China
Shandong Provincial Hospital of Dermatology
Jinan, , China
Shanghai Skin Disease Hospital
Shanghai, , China
The University of Hong Kong-Shenzhen Hospital
Shenzhen, , China
Wuhan Union Hospital
Wuhan, , China
Second Affiliated Hospital of Xi'an JiaoTong University
Xi'an, , China
HUS Tulehduskeskus /Ihosairauksien linja
Helsinki, , Finland
HOP Privé Antony
Antony, , France
HOP l'Archet
Nice, , France
HOP Saint-Louis
Paris, , France
Charite Universitätsmedizin Berlin KöR
Berlin, , Germany
Universitätsklinikum Erlangen
Erlangen, , Germany
Universitätsklinikum Essen AöR
Essen, , Germany
Universitätsklinikum Freiburg
Freiburg im Breisgau, , Germany
Universitätsklinikum Würzburg AÖR
Würzburg, , Germany
Fondazione IRCCS Ca'Granda-Ospedale Maggiore Policlinico
Milan, , Italy
Azienda Ospedaliera Universitaria Pisana
Pisa, , Italy
Istituti Fisioterapici Ospitalieri
Roma, , Italy
AOU Policlinico Umberto I
Roma, , Italy
Fondazione Policlinico Universitario A. Gemelli IRCCS
Roma, , Italy
Istituto Clinico Humanitas
Rozzano (MI), , Italy
AO Città della Salute e Scienza
Torino, , Italy
Fujita Health University Hospital
Aichi, Toyoake, , Japan
Hokkaido University Hospital
Hokkaido, Sapporo, , Japan
Hyogo College of Medicine Hospital
Hyogo, Nishinomiya, , Japan
Mie University Hospital
Mie, Tsu, , Japan
Tohoku University Hospital
Miyagi, Sendai, , Japan
Jichi Medical University Hospital
Tochigi, Shimotsuke, , Japan
Teikyo University Hospital
Tokyo, Itabashi-ku, , Japan
Nihon University Itabashi Hospital
Tokyo, Itabashi-ku, , Japan
Hospital Raja Permaisuri Bainun
Ipoh, , Malaysia
Sarawak General Hospital
Kuching, , Malaysia
Hospital Pulau Pinang-Pulau Pinang-21953
Pulau Pinang, , Malaysia
Oslo Universitetssykehus HF, Rikshospitalet
Oslo, , Norway
Helse Stavanger, Stavanger Universitetssykehus
Stavanger, , Norway
Military Medical Institute- National Research Institute
Warsaw, , Poland
Cityclinic Medical and Psychological Clinic Matusiak Partnership
Wroclaw, , Poland
ULS de Coimbra, E.P.E.
Coimbra, , Portugal
ULS de São José, E.P.E. - Hospital Sto. António Capuchos
Lisbon, , Portugal
ULS de Santa Maria, E.P.E
Lisbon, , Portugal
ULS de Santo Antônio, E.P.E - Centro Hospitalar Universitário de Santo António
Porto, , Portugal
Hospital Universitario Ramon Y Cajal
Madrid, , Spain
Hospital Virgen de la Victoria
Málaga, , Spain
Karolinska Universitetssjukhuset Solna
Stockholm, , Sweden
University Hospital Zurich
Zurich, , Switzerland
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, , Taiwan
Chang Gung Medical Foundation (CGMF) - Linkou Bran
Linkou District, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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Boehringer Ingelheim
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Related Links
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Related Info
Other Identifiers
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2024-514306-31-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
U1111-1306-8055
Identifier Type: REGISTRY
Identifier Source: secondary_id
1368-0140
Identifier Type: -
Identifier Source: org_study_id