New drug hopes to heal painful skin ulcers in rare disease

NCT ID NCT06624670

Recruiting now Disease control Sponsor: LEO Pharma Source: ClinicalTrials.gov ↗

First seen Jun 26, 2026 · Last updated Aug 04, 2026 · Updated 7 times

Summary

This study tests whether spesolimab, given as an infusion, can help close skin ulcers in adults with pyoderma gangrenosum, a rare inflammatory skin condition. About 90 participants will receive either spesolimab or a placebo, along with corticosteroids. The trial lasts about 1.5 years and includes 20 visits to check ulcer healing and safety.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: Spesolimab (a biologic drug given as an infusion into a vein)
What this could lead to: If it works, this could point toward a new treatment option for pyoderma gangrenosum, helping close painful skin ulcers.
What could go wrong: This is a Phase 3 trial, but it's still early to know if spesolimab is truly effective. The study is small (90 people) and results may not apply to everyone. Possible side effects include infusion reactions and infections.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

classic pyoderma gangrenosum pyoderma gangrenosum

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

PYODERMA GANGRENOSUM

Contacts and locations

Locations

Ada West Research
RECRUITING

Meridian, Idaho, 83646, United States
Advanced Medical Research PC
NOT_YET_RECRUITING

Sandy Springs, Georgia, 30328, United States
Alfred Hospital
RECRUITING

Melbourne, Victoria, 3004, Australia
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
RECRUITING

Torino, 10126, Italy
Azienda Ospedaliera Universitaria Pisana
RECRUITING

Pisa, 56126, Italy
Brigham and Women's Hospital
RECRUITING

Boston, Massachusetts, 02115, United States
CHUC - Centro Hospitalar e Universitario de Coimbra, EPE
RECRUITING

Coimbra, 3004-561, Portugal
CIPREC
COMPLETED

CABA, 1602, Argentina
Centre de Recherche Saint-Louis
RECRUITING

Québec, G1W 4R4, Canada
Chang Gung Medical Foundation (CGMF) - Linkou Bran
RECRUITING

Linkou District, 333, Taiwan
Charité - Universitätsmedizin Berlin
RECRUITING

Berlin, 10117, Germany
Chronos Pesquisa Clinica
RECRUITING

Brasília, 72145-450, Brazil
Cityclinic Medical and Psychological Clinic Matusiak Partnership
RECRUITING

Wroclaw, 50-566, Poland
Cleveland Clinic
RECRUITING

Cleveland, Ohio, 44195, United States
Dartmouth Hitchcock Clinics Heater Road
RECRUITING

Lebanon, New Hampshire, 03766, United States
Dawes Fretzin Clinical Research Group, LLC-Indianapolis -68995
RECRUITING

Indianapolis, Indiana, 46250, United States
Dermatology & Cosmetic Center PLLC - Flint
NOT_YET_RECRUITING

Flint, Michigan, 48507, United States
Dermatology at Lake Success
RECRUITING

Lake Success, New York, 11042, United States
Epiphany Dermatology
RECRUITING

Lewisville, Texas, 75056, United States
Faculdade de Medicina do ABC
RECRUITING

Santo André, 09060-870, Brazil
Fondazione IRCCS Ca'Granda-Ospedale Maggiore Policlinico
RECRUITING

Milan, 20122, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
RECRUITING

Roma, 00168, Italy
Fujita Health University Hospital
RECRUITING

Aichi, Toyoake, 470-1192, Japan
HOP Privé Antony
RECRUITING

Antony, 92160, France
HOP Saint-Louis
RECRUITING

Paris, 75010, France
HUS Tulehduskeskus /Ihosairauksien linja
RECRUITING

Helsinki, 00029, Finland
Hangzhou Third People's Hospital
RECRUITING

Hangzhou, 310013, China
Helse Stavanger, Stavanger Universitetssykehus
RECRUITING

Stavanger, N-4011, Norway
Hokkaido University Hospital
RECRUITING

Hokkaido, Sapporo, 060-8648, Japan
Hospital Italiano de Buenos Aires
COMPLETED

CABA, C1056AB, Argentina
Hospital Pulau Pinang-Pulau Pinang-21953
RECRUITING

Pulau Pinang, 10450, Malaysia
Hospital Raja Permaisuri Bainun
RECRUITING

Ipoh, 30450, Malaysia
Hospital Universitario La Paz
NOT_YET_RECRUITING

Madrid, 28046, Spain
Hospital Universitario Ramon Y Cajal
RECRUITING

Madrid, 28034, Spain
Hospital Universitario Virgen de la Victoria
RECRUITING

Málaga, 29010, Spain
Hospital del Mar
NOT_YET_RECRUITING

Barcelona, 08003, Spain
Hyogo College of Medicine Hospital
RECRUITING

Hyogo, Nishinomiya, 663-8501, Japan
Hôpital Edouard Herriot
NOT_YET_RECRUITING

Lyon, 69437, France
Hôpital de l'Archet
RECRUITING

Nice, 06200, France
Icahn School of Medicine at Mount Sinai
RECRUITING

New York, New York, 10029, United States
Instituto de Especialidades de la Salud Rosario
COMPLETED

Rosario, 2000, Argentina
Istituti Fisioterapici Ospitalieri
RECRUITING

Roma, 00128, Italy
Istituto Clinico Humanitas
RECRUITING

Rozzano (MI), 20089, Italy
Jichi Medical University Hospital
RECRUITING

Tochigi, Shimotsuke, 329-0498, Japan
Kaohsiung Chang Gung Memorial Hospital
RECRUITING

Kaohsiung City, 83301, Taiwan
Karolinska Universitetssjukhuset Solna
RECRUITING

Stockholm, 17176, Sweden
LKH Salzburg University Hospital
RECRUITING

Salzburg, 5020, Austria
McGill University Health Centre (MUHC)
RECRUITING

Montreal, Quebec, H4A 3J1, Canada
Medical Dermatology Specialists Phoenix
RECRUITING

Phoenix, Arizona, 85006, United States
Medical University of Graz
RECRUITING

Graz, 8036, Austria
Mie University Hospital
RECRUITING

Mie, Tsu, 514-8507, Japan
Military Medical Institute- National Research Institute
RECRUITING

Warsaw, 04 141, Poland
National Taiwan University Hospital
RECRUITING

Taipei, 100, Taiwan
Nihon University Itabashi Hospital
RECRUITING

Tokyo, Itabashi-ku, 173-8610, Japan
Oregon Health and Sciences University
RECRUITING

Portland, Oregon, 97239, United States
Oslo Universitetssykehus HF, Rikshospitalet
RECRUITING

Oslo, 0372, Norway
Peking University People's Hospital
RECRUITING

Beijing, 100044, China
Peking University Third Hospital
RECRUITING

Beijing, 100191, China
Red River Research Partners, LLC
RECRUITING

Fargo, North Dakota, 58103, United States
Rejuvenation Dermatology Clinic
RECRUITING

Edmonton, Alberta, T5J 3S9, Canada
Royal North Shore Hospital-St Leonards-20807
RECRUITING

St Leonards, New South Wales, 2065, Australia
Sarawak General Hospital
RECRUITING

Kuching, 93586, Malaysia
Second Affiliated Hospital of Xi'an JiaoTong University
RECRUITING

Xi'an, 710004, China
Shandong Provincial Hospital of Dermatology
RECRUITING

Jinan, 250063, China
Shanghai Skin Disease Hospital
RECRUITING

Shanghai, 200000, China
Skin and Cancer Foundation
RECRUITING

Darlinghurst, New South Wales, 2010, Australia
Teikyo University Hospital
RECRUITING

Tokyo, Itabashi-ku, 173-8606, Japan
The First Affiliated Hospital, Zhejiang University
RECRUITING

Hangzhou, 310003, China
The First Hospital of Jilin University
RECRUITING

Changchun, 130000, China
The Ohio State University Wexner Medical Center
RECRUITING

Columbus, Ohio, 43210, United States
The Second Affiliated Hospital Zhejiang University School of Medicine
RECRUITING

Hangzhou, 310009, China
The Second Xiangya Hospital Of Central South University
RECRUITING

Changsha, 410011, China
The University of Hong Kong-Shenzhen Hospital
RECRUITING

Shenzhen, 518053, China
Tohoku University Hospital
RECRUITING

Miyagi, Sendai, 980-8574, Japan
Tulane University Hospital and Clinic
RECRUITING

New Orleans, Louisiana, 70112, United States
ULS de Santa Maria, E.P.E
RECRUITING

Lisbon, 1649-035, Portugal
ULS de Santo Antônio, E.P.E - Centro Hospitalar Universitário de Santo António
RECRUITING

Porto, 4099-001, Portugal
ULS de São José, E.P.E. - Hospital Sto. António Capuchos
RECRUITING

Lisbon, 1169-050, Portugal
UZ Leuven
RECRUITING

Leuven, 3000, Belgium
University Hospital Zurich
RECRUITING

Zurich, 8091, Switzerland
University of Alabama at Birmingham
RECRUITING

Birmingham, Alabama, 35233, United States
University of Alberta Hospital (University of Alberta)
RECRUITING

Edmonton, Alberta, T6G 2B7, Canada
University of California Irvine
RECRUITING

Irvine, California, 92697, United States
University of Miami
RECRUITING

Miami, Florida, 33136, United States
University of Michigan
RECRUITING

Ann Arbor, Michigan, 48109, United States
University of Pennsylvania
RECRUITING

Philadelphia, Pennsylvania, 19104, United States
University of South Florida
RECRUITING

Tampa, Florida, 33612, United States
University of Utah Health MidValley Dermatology
RECRUITING

Murray, Utah, 84107, United States
Universitätsklinikum Düsseldorf
NOT_YET_RECRUITING

Düsseldorf, 40225, Germany
Universitätsklinikum Erlangen
RECRUITING

Erlangen, 91054, Germany
Universitätsklinikum Essen AöR
RECRUITING

Essen, 45147, Germany
Universitätsklinikum Freiburg
RECRUITING

Freiburg im Breisgau, 79104, Germany
Universitätsklinikum Hamburg, Eppendorf
NOT_YET_RECRUITING

Hamburg, 20246, Germany
Universitätsklinikum Tübingen
NOT_YET_RECRUITING

Tübingen, 72076, Germany
Universitätsklinikum Würzburg AÖR
RECRUITING

Würzburg, 97080, Germany
Washington University School of Medicine
NOT_YET_RECRUITING

St Louis, Missouri, 63110, United States
West China Hospital, Sichuan University
RECRUITING

Chengdu, 610041, China
Westmead Hospital
NOT_YET_RECRUITING

Westmead, New South Wales, 2145, Australia
Women's College Hospital
RECRUITING

Toronto, Ontario, M5S 1B2, Canada
Wuhan Union Hospital
RECRUITING

Wuhan, 430022, China

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