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NCT06624670PHASE3Recruiting

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

Boehringer Ingelheim

Start Date

2/5/2025

Completion Date

8/19/2028

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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.

Interventions

DRUG

Spesolimab

DRUG

Placebo matching to spesolimab

DRUG

Prednisone

DRUG

Prednisolone

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Conditions

Pyoderma Gangrenosum

Locations

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

Advanced Medical Research PC

Sandy Springs, Georgia 30328

United States

Ada West Research

Meridian, Idaho 83646

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

Dermatology & Cosmetic Center PLLC - Flint

Flint, Michigan 48507

United States

Washington University School of Medicine

St Louis, Missouri 63110

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 of 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 Universitario 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