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New drug hopes to heal painful skin ulcers in rare disease

NCT ID NCT06624670

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

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Sep 03, 2026 · Updated 9 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.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 90 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2025

Expected to finish

Aug 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    95 sites in 20 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

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

  • Illinois Dermatology Institute - Chicago Loop Office

    NOT_YET_RECRUITING

    Chicago, Illinois, 60602, 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 - Lee's Summit

    NOT_YET_RECRUITING

    Lee's Summit, Missouri, 64086, United States

  • 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 medical college of Xi'an JiaoTong University

    ACTIVE_NOT_RECRUITING

    Xi'an, 710004, China

  • Shandong Provincial Hospital of Dermatology

    ACTIVE_NOT_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

    ACTIVE_NOT_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

    ACTIVE_NOT_RECRUITING

    Hangzhou, 310009, China

  • The Second Xiangya Hospital Of Central South University

    ACTIVE_NOT_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

  • Union Hospital Tongji Medical College Huazhong University of Science and Technology

    RECRUITING

    Wuhan, 430022, China

  • University Health

    NOT_YET_RECRUITING

    Kansas City, Missouri, 64108, United States

  • 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

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