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Een onderzoek om te testen of Spesolimab mensen helpt met een huidaandoening genaamd Pyoderma Gangrenosum

6 november 2026 bijgewerkt door: LEO Pharma

Een multicenter, gerandomiseerde, placebogecontroleerde, dubbelblinde studie met parallelle groepen om de veiligheid en werkzaamheid van Spesolimab te evalueren (BI 655130) bij volwassen patiënten met ulceratieve Pyoderma Gangrenosum (PG) die systemische therapie nodig hebben

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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

90

Fase

  • Fase 3

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • Argentinië
      • CABA, Argentinië, 1602
        • Voltooid
        • CIPREC
      • CABA, Argentinië, C1056AB
        • Voltooid
        • Hospital Italiano de Buenos Aires
      • Rosario, Argentinië, 2000
        • Voltooid
        • Instituto de Especialidades de la Salud Rosario
  • Australië
    • New South Wales
      • Darlinghurst, New South Wales, Australië, 2010
      • St Leonards, New South Wales, Australië, 2065
        • Werving
        • Royal North Shore Hospital-St Leonards-20807
        • Contact:
      • Westmead, New South Wales, Australië, 2145
    • Victoria
      • Melbourne, Victoria, Australië, 3004
  • België
  • Brazilië
      • Brasília, Brazilië, 72145-450
        • Werving
        • Chronos Pesquisa Clinica
        • Contact:
      • Santo André, Brazilië, 09060-870
        • Werving
        • Faculdade de Medicina do ABC
        • Contact:
  • Canada
      • Québec, Canada, G1W 4R4
        • Werving
        • Centre de Recherche Saint-Louis
        • Contact:
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2B7
        • Werving
        • University of Alberta Hospital (University of Alberta)
        • Contact:
      • Edmonton, Alberta, Canada, T5J 3S9
        • Werving
        • Rejuvenation Dermatology Clinic
        • Contact:
    • Ontario
      • Toronto, Ontario, Canada, M5S 1B2
        • Werving
        • Women's College Hospital
        • Contact:
    • Quebec
      • Montreal, Quebec, Canada, H4A 3J1
        • Werving
        • McGill University Health Centre (MUHC)
        • Contact:
  • China
      • Beijing, China, 100191
        • Werving
        • Peking University Third Hospital
        • Contact:
      • Beijing, China, 100044
        • Werving
        • Peking University People's Hospital
        • Contact:
      • Changchun, China, 130000
        • Werving
        • The First Hospital of Jilin University
        • Contact:
      • Changsha, China, 410011
        • Actief, niet wervend
        • The Second Xiangya Hospital Of Central South University
      • Chengdu, China, 610041
        • Werving
        • West China Hospital, Sichuan University
        • Contact:
      • Hangzhou, China, 310009
        • Actief, niet wervend
        • The Second Affiliated Hospital Zhejiang University School of Medicine
      • Hangzhou, China, 310003
        • Actief, niet wervend
        • The First Affiliated Hospital, Zhejiang University
      • Hangzhou, China, 310013
        • Werving
        • Hangzhou Third People's Hospital
        • Contact:
      • Jinan, China, 250063
        • Actief, niet wervend
        • Shandong Provincial Hospital of Dermatology
      • Shanghai, China, 200000
        • Werving
        • Shanghai Skin Disease Hospital
        • Contact:
      • Shenzhen, China, 518053
        • Werving
        • The University of Hong Kong-Shenzhen Hospital
        • Contact:
      • Wuhan, China, 430022
        • Werving
        • Union Hospital Tongji Medical College Huazhong University of Science and Technology
        • Contact:
      • Xi'an, China, 710004
        • Actief, niet wervend
        • Second Affiliated Hospital of medical college of Xi'an JiaoTong University
  • Duitsland
      • Berlin, Duitsland, 10117
      • Düsseldorf, Duitsland, 40225
        • Nog niet aan het werven
        • Universitätsklinikum Düsseldorf
        • Contact:
      • Erlangen, Duitsland, 91054
      • Essen, Duitsland, 45147
      • Freiburg im Breisgau, Duitsland, 79104
      • Hamburg, Duitsland, 20246
      • Tübingen, Duitsland, 72076
        • Nog niet aan het werven
        • Universitätsklinikum Tübingen
        • Contact:
      • Würzburg, Duitsland, 97080
  • Finland
      • Helsinki, Finland, 00029
        • Werving
        • HUS Tulehduskeskus /Ihosairauksien linja
        • Contact:
  • Frankrijk
      • Antony, Frankrijk, 92160
      • Lyon, Frankrijk, 69437
        • Werving
        • Hôpital Edouard Herriot
        • Contact:
      • Nice, Frankrijk, 06200
      • Paris, Frankrijk, 75010
  • Italië
      • Milan, Italië, 20122
        • Werving
        • Fondazione IRCCS Ca'Granda-Ospedale Maggiore Policlinico
        • Contact:
      • Pisa, Italië, 56126
        • Werving
        • Azienda Ospedaliera Universitaria Pisana
        • Contact:
      • Roma, Italië, 00168
        • Werving
        • Fondazione Policlinico Universitario Agostino Gemelli IRCCS
        • Contact:
      • Roma, Italië, 00161
        • Werving
        • AOU Policlinico Umberto I
        • Contact:
      • Roma, Italië, 00128
        • Werving
        • Istituti Fisioterapici Ospitalieri
        • Contact:
      • Rozzano (MI), Italië, 20089
        • Werving
        • Istituto Clinico Humanitas
        • Contact:
      • Torino, Italië, 10126
        • Werving
        • Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
        • Contact:
  • Japan
      • Aichi, Toyoake, Japan, 470-1192
        • Werving
        • Fujita Health University Hospital
        • Contact:
      • Hokkaido, Sapporo, Japan, 060-8648
        • Werving
        • Hokkaido University Hospital
        • Contact:
      • Hyogo, Nishinomiya, Japan, 663-8501
        • Werving
        • Hyogo College of Medicine Hospital
        • Contact:
      • Mie, Tsu, Japan, 514-8507
        • Werving
        • Mie University Hospital
        • Contact:
      • Miyagi, Sendai, Japan, 980-8574
        • Werving
        • Tohoku University Hospital
        • Contact:
      • Tochigi, Shimotsuke, Japan, 329-0498
        • Werving
        • Jichi Medical University Hospital
        • Contact:
      • Tokyo, Itabashi-ku, Japan, 173-8610
        • Werving
        • Nihon University Itabashi Hospital
        • Contact:
      • Tokyo, Itabashi-ku, Japan, 173-8606
        • Werving
        • Teikyo University Hospital
        • Contact:
  • Maleisië
      • Ipoh, Maleisië, 30450
      • Kuching, Maleisië, 93586
      • Pulau Pinang, Maleisië, 10450
        • Werving
        • Hospital Pulau Pinang-Pulau Pinang-21953
        • Contact:
  • Noorwegen
      • Oslo, Noorwegen, 0372
        • Werving
        • Oslo Universitetssykehus HF, Rikshospitalet
        • Contact:
      • Stavanger, Noorwegen, N-4011
        • Werving
        • Helse Stavanger, Stavanger Universitetssykehus
        • Contact:
  • Oostenrijk
      • Graz, Oostenrijk, 8036
      • Salzburg, Oostenrijk, 5020
  • Polen
      • Warsaw, Polen, 04 141
        • Werving
        • Military Medical Institute- National Research Institute
        • Contact:
      • Wroclaw, Polen, 50-566
        • Werving
        • Cityclinic Medical and Psychological Clinic Matusiak Partnership
        • Contact:
  • Portugal
      • Coimbra, Portugal, 3004-561
        • Werving
        • CHUC - Centro Hospitalar e Universitario de Coimbra, EPE
        • Contact:
      • Lisbon, Portugal, 1649-035
      • Lisbon, Portugal, 1169-050
        • Werving
        • ULS de São José, E.P.E. - Hospital Sto. António Capuchos
        • Contact:
      • Porto, Portugal, 4099-001
        • Werving
        • ULS de Santo Antônio, E.P.E - Centro Hospitalar Universitário de Santo António
        • Contact:
  • Spanje
      • Barcelona, Spanje, 08003
      • Madrid, Spanje, 28046
        • Werving
        • Hospital Universitario La Paz
        • Contact:
      • Madrid, Spanje, 28034
        • Werving
        • Hospital Universitario Ramon Y Cajal
        • Contact:
      • Málaga, Spanje, 29010
        • Werving
        • Hospital Universitario Virgen de la Victoria
        • Contact:
  • Taiwan
      • Kaohsiung City, Taiwan, 83301
        • Werving
        • Kaohsiung Chang Gung Memorial Hospital
        • Contact:
      • Linkou District, Taiwan, 333
        • Werving
        • Chang Gung Medical Foundation (CGMF) - Linkou Bran
        • Contact:
      • Taipei, Taiwan, 100
        • Werving
        • National Taiwan University Hospital
        • Contact:
  • Verenigde Staten
    • Alabama
      • Birmingham, Alabama, Verenigde Staten, 35233
    • Arizona
      • Phoenix, Arizona, Verenigde Staten, 85006
    • California
      • Irvine, California, Verenigde Staten, 92697
    • Florida
      • Miami, Florida, Verenigde Staten, 33136
      • Tampa, Florida, Verenigde Staten, 33612
    • Georgia
      • Sandy Springs, Georgia, Verenigde Staten, 30328
    • Idaho
      • Meridian, Idaho, Verenigde Staten, 83646
    • Illinois
      • Chicago, Illinois, Verenigde Staten, 60602
    • Indiana
      • Indianapolis, Indiana, Verenigde Staten, 46250
        • Werving
        • Dawes Fretzin Clinical Research Group, LLC-Indianapolis -68995
        • Contact:
    • Louisiana
      • New Orleans, Louisiana, Verenigde Staten, 70112
    • Massachusetts
      • Boston, Massachusetts, Verenigde Staten, 02115
    • Michigan
      • Ann Arbor, Michigan, Verenigde Staten, 48109
      • Flint, Michigan, Verenigde Staten, 48507
    • Missouri
      • Kansas City, Missouri, Verenigde Staten, 64108
      • Lee's Summit, Missouri, Verenigde Staten, 64086
      • St Louis, Missouri, Verenigde Staten, 63110
        • Nog niet aan het werven
        • Washington University School of Medicine
        • Contact:
    • New Hampshire
      • Lebanon, New Hampshire, Verenigde Staten, 03766
    • New York
      • Lake Success, New York, Verenigde Staten, 11042
      • New York, New York, Verenigde Staten, 10029
    • North Dakota
      • Fargo, North Dakota, Verenigde Staten, 58103
    • Ohio
      • Cleveland, Ohio, Verenigde Staten, 44195
      • Columbus, Ohio, Verenigde Staten, 43210
        • Werving
        • The Ohio State University Wexner Medical Center
        • Contact:
    • Oregon
      • Portland, Oregon, Verenigde Staten, 97239
    • Pennsylvania
      • Philadelphia, Pennsylvania, Verenigde Staten, 19104
    • Texas
      • Lewisville, Texas, Verenigde Staten, 75056
    • Utah
      • Murray, Utah, Verenigde Staten, 84107
        • Werving
        • University of Utah Health MidValley Dermatology
        • Contact:
  • Zweden
      • Stockholm, Zweden, 17176
        • Werving
        • Karolinska Universitetssjukhuset Solna
        • Contact:
  • Zwitserland
      • Zurich, Zwitserland, 8091
        • Werving
        • University Hospital Zurich
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Dubbele

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Placebo-vergelijker: Placebo
Geneesmiddel: Prednisone

Prednisone

Geneesmiddel: Prednisolone

Prednisolone

Geneesmiddel: Placebo matching to spesolimab

Placebo matching to spesolimab
Experimenteel: Spesolimab
Geneesmiddel: Spesolimab

Solution for infusion

Geneesmiddel: Prednisone

Prednisone

Geneesmiddel: Prednisolone

Prednisolone

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Achievement of complete closure (PGAR-100 (100% pyoderma gangrenosum area reduction)) of the target PG ulcer at any time up to Week 26 and confirmed at the next consecutive visit (at least 2 weeks later)
Tijdsspanne: Up to Week 28.

PGAR-100 is defined as complete closure and re-epithelisation of a PG ulcer without drainage and requirements for dressing.
Up to Week 28.

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Key secondary endpoint: Achievement of PGAR-100 of the target PG ulcer at Week 26 confirmed at the next consecutive visit (at least 2 weeks later)
Tijdsspanne: Up to Week 28.

PGAR-100 is defined as complete closure and re-epithelisation of a PG ulcer without drainage and requirements for dressing.
Up to Week 28.
Achievement of 50% area reduction (PGAR-50) of the target PG ulcer at any time up to Week 26
Tijdsspanne: Up to Week 26.

Achievement of a PGAR-50 defines an area reduction of a PG ulcer from baseline by 50%.
Up to Week 26.
Achievement of ≥ 3 point reduction in NRS Pain score from baseline at Week 26
Tijdsspanne: At baseline and at Week 26.

Numeric Rating Scale for Pain (NRS Pain) is a unidimensional measure of pain intensity. It is a 11-point numeric scale, in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of their pain, with 0 representing "no pain" and 10 representing "worst pain imaginable". Trial participant is asked to report their pain intensity in the last 24 h.
At baseline and at Week 26.
Achievement of a DLQI of ≤ 5 at Week 26
Tijdsspanne: At Week 26.

Dermatology Life Quality Index (DLQI) is a trial participant-administered, quality of life questionnaire consisting of 10 questions that cover 6 domains (symptoms and feelings, daily activities, leisure, work and school, personal relationships, problems with treatment).

Response categories include "not relevant" or "not at all" (score of 0), "a little" (score of 1), "a lot" (score of 2) and "very much" (score of 3). Question 7 is a "yes"/ "no" question where "yes" is scored as 3. DLQI total score is calculated by summing the scores of each question, resulting in a range of 0 to 30, with higher scores indicating more impairment of a trial participant's quality of life.
At Week 26.
Achievement of complete response
Tijdsspanne: At Week 26.

Complete response (CR), defined as all ulcers completely closed and re- epithelised without drainage and requirements for dressing, as assessed by the investigator).
At Week 26.
Achievement of PGAR-100 of any measurable PG ulcer (≥5 cm^2 at baseline) at any time up to Week 26 and confirmed at the next consecutive visit (at least 2 weeks later)
Tijdsspanne: Up to Week 28.

PGAR-100 is defined as complete closure and re-epithelisation of a PG ulcer without drainage and requirements for dressing.
Up to Week 28.
Achievement of PGAR-100 of all measurable PG ulcers (≥5 cm^2 at baseline) at any time up to Week 26 and confirmed at the next consecutive visit (at least 2 weeks later)
Tijdsspanne: Up to Week 28.

PGAR-100 is defined as complete closure and re-epithelisation of a PG ulcer without drainage and requirements for dressing.
Up to Week 28.
Time to recurrence among trial participants who had achieved CR at Week 26 up to Week 52
Tijdsspanne: Up to Week 52.

Recurrence is defined as emergence of the disease (PG ulcer[s]) at the previous ulcer sites(s) or emergence of any new PG ulcer(s).
Up to Week 52.

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

LEO Pharma

Medewerkers

Boehringer Ingelheim

Onderzoekers

  • Studie directeur: Medical Expert, LEO Pharma

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

5 februari 2025

Primaire voltooiing (Geschat)

12 november 2027

Studie voltooiing (Geschat)

19 augustus 2028

Studieregistratiedata

Eerst ingediend

30 september 2024

Eerst ingediend dat voldeed aan de QC-criteria

30 september 2024

Eerst geplaatst (Werkelijk)

3 oktober 2024

Updates van studierecords

Laatste update geplaatst (Werkelijk)

9 november 2026

Laatste update ingediend die voldeed aan QC-criteria

6 november 2026

Laatst geverifieerd

1 november 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 1368-0140
  • U1111-1306-8055 (Register-ID: World Health Organization (WHO))
  • 2024-514306-31-00 (Ctis)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Ja

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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