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RECRUITING

NCT06624670

PHASE3

A Study to Test Whether Spesolimab Helps People With a Skin Condition Called Pyoderma Gangrenosum

Sponsor: Boehringer Ingelheim

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2025-02-04

Completion Date

2028-02-01

Last Updated

2026-03-31

Healthy Volunteers

Conditions

Pyoderma Gangrenosum

Interventions

DRUG

Spesolimab

Solution for infusion

DRUG

Placebo matching to spesolimab

DRUG

Prednisone

DRUG

Prednisolone

Inclusion criteria: 1. Adult trial participants, aged ≥18 years (if local legislation for age of consent differs, then local legislation will be followed) at screening. 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: 1. Trial participants with non-PG lesions. 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. Further exclusion criteria apply.

Locations (95)

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

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

University of Utah Health

Murray, Utah, 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 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, 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

Hôpital Edouard Herriot

Lyon, France

Hôpital de l'Archet

Nice, France

HOP Saint-Louis

Paris, France

Charité - Universitätsmedizin Berlin

Berlin, Germany

Universitätsklinikum Düsseldorf

Düsseldorf, Germany

Universitätsklinikum Erlangen

Erlangen, Germany

Universitätsklinikum Essen AöR

Essen, Germany

Universitätsklinikum Freiburg

Freiburg im Breisgau, Germany

Universitätsklinikum Hamburg, Eppendorf

Hamburg, Germany

Universitätsklinikum Tübingen

Tübingen, 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

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, Italy

Istituto Clinico Humanitas

Rozzano (MI), Italy

Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino

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

CHUC - Centro Hospitalar e Universitário de Coimbra, EPE

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 del Mar

Barcelona, Spain

Hospital Universitario Ramon Y Cajal

Madrid, Spain

Hospital Universitario La Paz

Madrid, Spain

Hospital Universitario 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

Clinical Research Directory

A Study to Test Whether Spesolimab Helps People With a Skin Condition Called Pyoderma Gangrenosum

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (95)