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En undersøgelse for at teste, om Spesolimab hjælper mennesker med en hudlidelse kaldet Pyoderma Gangrenosum

6. november 2026 opdateret af: LEO Pharma

Et multicenter, randomiseret, placebokontrolleret, dobbeltblindt, parallelgruppeforsøg til evaluering af sikkerhed og effektivitet af Spesolimab (BI 655130) hos voksne patienter med ulcerøs pyoderma gangrenosum (PG), som kræver systemisk terapi

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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

90

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Argentina
      • CABA, Argentina, 1602
        • Afsluttet
        • CIPREC
      • CABA, Argentina, C1056AB
        • Afsluttet
        • Hospital Italiano de Buenos Aires
      • Rosario, Argentina, 2000
        • Afsluttet
        • Instituto de Especialidades de la Salud Rosario
  • Australien
    • New South Wales
      • Darlinghurst, New South Wales, Australien, 2010
      • St Leonards, New South Wales, Australien, 2065
        • Rekruttering
        • Royal North Shore Hospital-St Leonards-20807
        • Kontakt:
      • Westmead, New South Wales, Australien, 2145
    • Victoria
      • Melbourne, Victoria, Australien, 3004
  • Belgien
      • Leuven, Belgien, 3000
  • Brasilien
      • Brasília, Brasilien, 72145-450
        • Rekruttering
        • Chronos Pesquisa Clinica
        • Kontakt:
      • Santo André, Brasilien, 09060-870
        • Rekruttering
        • Faculdade de Medicina do ABC
        • Kontakt:
  • Canada
      • Québec, Canada, G1W 4R4
        • Rekruttering
        • Centre de Recherche Saint-Louis
        • Kontakt:
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2B7
        • Rekruttering
        • University of Alberta Hospital (University of Alberta)
        • Kontakt:
      • Edmonton, Alberta, Canada, T5J 3S9
        • Rekruttering
        • Rejuvenation Dermatology Clinic
        • Kontakt:
    • Ontario
      • Toronto, Ontario, Canada, M5S 1B2
        • Rekruttering
        • Women's College Hospital
        • Kontakt:
    • Quebec
      • Montreal, Quebec, Canada, H4A 3J1
        • Rekruttering
        • McGill University Health Centre (MUHC)
        • Kontakt:
  • Finland
      • Helsinki, Finland, 00029
        • Rekruttering
        • HUS Tulehduskeskus /Ihosairauksien linja
        • Kontakt:
  • Forenede Stater
    • Alabama
      • Birmingham, Alabama, Forenede Stater, 35233
    • Arizona
      • Phoenix, Arizona, Forenede Stater, 85006
    • California
      • Irvine, California, Forenede Stater, 92697
    • Florida
      • Miami, Florida, Forenede Stater, 33136
      • Tampa, Florida, Forenede Stater, 33612
    • Georgia
      • Sandy Springs, Georgia, Forenede Stater, 30328
    • Idaho
      • Meridian, Idaho, Forenede Stater, 83646
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60602
    • Indiana
      • Indianapolis, Indiana, Forenede Stater, 46250
        • Rekruttering
        • Dawes Fretzin Clinical Research Group, LLC-Indianapolis -68995
        • Kontakt:
    • Louisiana
      • New Orleans, Louisiana, Forenede Stater, 70112
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02115
    • Michigan
      • Ann Arbor, Michigan, Forenede Stater, 48109
      • Flint, Michigan, Forenede Stater, 48507
        • Rekruttering
        • Dermatology & Cosmetic Center PLLC - Flint
        • Kontakt:
    • Missouri
      • Kansas City, Missouri, Forenede Stater, 64108
      • Lee's Summit, Missouri, Forenede Stater, 64086
        • Rekruttering
        • Red River Research Partners - Lee's Summit
        • Kontakt:
      • St Louis, Missouri, Forenede Stater, 63110
        • Ikke rekrutterer endnu
        • Washington University School of Medicine
        • Kontakt:
    • New Hampshire
      • Lebanon, New Hampshire, Forenede Stater, 03766
    • New York
      • Lake Success, New York, Forenede Stater, 11042
      • New York, New York, Forenede Stater, 10029
    • North Dakota
      • Fargo, North Dakota, Forenede Stater, 58103
    • Ohio
      • Cleveland, Ohio, Forenede Stater, 44195
      • Columbus, Ohio, Forenede Stater, 43210
        • Rekruttering
        • The Ohio State University Wexner Medical Center
        • Kontakt:
    • Oregon
      • Portland, Oregon, Forenede Stater, 97239
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forenede Stater, 19104
    • Texas
      • Lewisville, Texas, Forenede Stater, 75056
    • Utah
      • Murray, Utah, Forenede Stater, 84107
        • Rekruttering
        • University of Utah Health MidValley Dermatology
        • Kontakt:
  • Frankrig
      • Antony, Frankrig, 92160
      • Lyon, Frankrig, 69437
        • Rekruttering
        • Hôpital Edouard Herriot
        • Kontakt:
      • Nice, Frankrig, 06200
        • Rekruttering
        • Hôpital de l'Archet
        • Kontakt:
      • Paris, Frankrig, 75010
  • Italien
      • Milan, Italien, 20122
        • Rekruttering
        • Fondazione IRCCS Ca'Granda-Ospedale Maggiore Policlinico
        • Kontakt:
      • Pisa, Italien, 56126
        • Rekruttering
        • Azienda Ospedaliera Universitaria Pisana
        • Kontakt:
      • Roma, Italien, 00168
        • Rekruttering
        • Fondazione Policlinico Universitario Agostino Gemelli IRCCS
        • Kontakt:
      • Roma, Italien, 00161
        • Rekruttering
        • AOU Policlinico Umberto I
        • Kontakt:
      • Roma, Italien, 00128
        • Rekruttering
        • Istituti Fisioterapici Ospitalieri
        • Kontakt:
      • Rozzano (MI), Italien, 20089
        • Rekruttering
        • Istituto Clinico Humanitas
        • Kontakt:
      • Torino, Italien, 10126
        • Rekruttering
        • Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
        • Kontakt:
  • Japan
      • Aichi, Toyoake, Japan, 470-1192
        • Rekruttering
        • Fujita Health University Hospital
        • Kontakt:
      • Hokkaido, Sapporo, Japan, 060-8648
        • Rekruttering
        • Hokkaido University Hospital
        • Kontakt:
      • Hyogo, Nishinomiya, Japan, 663-8501
        • Rekruttering
        • Hyogo College of Medicine Hospital
        • Kontakt:
      • Mie, Tsu, Japan, 514-8507
        • Rekruttering
        • Mie University Hospital
        • Kontakt:
      • Miyagi, Sendai, Japan, 980-8574
        • Rekruttering
        • Tohoku University Hospital
        • Kontakt:
      • Tochigi, Shimotsuke, Japan, 329-0498
        • Rekruttering
        • Jichi Medical University Hospital
        • Kontakt:
      • Tokyo, Itabashi-ku, Japan, 173-8610
        • Rekruttering
        • Nihon University Itabashi Hospital
        • Kontakt:
      • Tokyo, Itabashi-ku, Japan, 173-8606
        • Rekruttering
        • Teikyo University Hospital
        • Kontakt:
  • Kina
      • Beijing, Kina, 100191
        • Rekruttering
        • Peking University Third Hospital
        • Kontakt:
      • Beijing, Kina, 100044
        • Rekruttering
        • Peking University People's Hospital
        • Kontakt:
      • Changchun, Kina, 130000
        • Rekruttering
        • The First Hospital of Jilin University
        • Kontakt:
      • Changsha, Kina, 410011
        • Aktiv, ikke rekrutterende
        • The Second Xiangya Hospital Of Central South University
      • Chengdu, Kina, 610041
        • Rekruttering
        • West China Hospital, Sichuan University
        • Kontakt:
      • Hangzhou, Kina, 310009
        • Aktiv, ikke rekrutterende
        • The Second Affiliated Hospital Zhejiang University School of Medicine
      • Hangzhou, Kina, 310003
        • Aktiv, ikke rekrutterende
        • The First Affiliated Hospital, Zhejiang University
      • Hangzhou, Kina, 310013
        • Rekruttering
        • Hangzhou Third People's Hospital
        • Kontakt:
      • Jinan, Kina, 250063
        • Aktiv, ikke rekrutterende
        • Shandong Provincial Hospital of Dermatology
      • Shanghai, Kina, 200000
        • Rekruttering
        • Shanghai Skin Disease Hospital
        • Kontakt:
      • Shenzhen, Kina, 518053
        • Rekruttering
        • The University of Hong Kong-Shenzhen Hospital
        • Kontakt:
      • Wuhan, Kina, 430022
        • Rekruttering
        • Union Hospital Tongji Medical College Huazhong University of Science and Technology
        • Kontakt:
      • Xi'an, Kina, 710004
        • Aktiv, ikke rekrutterende
        • Second Affiliated Hospital of medical college of Xi'an JiaoTong University
  • Malaysia
      • Ipoh, Malaysia, 30450
        • Rekruttering
        • Hospital Raja Permaisuri Bainun
        • Kontakt:
      • Kuching, Malaysia, 93586
      • Pulau Pinang, Malaysia, 10450
        • Rekruttering
        • Hospital Pulau Pinang-Pulau Pinang-21953
        • Kontakt:
  • Norge
      • Oslo, Norge, 0372
        • Rekruttering
        • Oslo Universitetssykehus HF, Rikshospitalet
        • Kontakt:
      • Stavanger, Norge, N-4011
        • Rekruttering
        • Helse Stavanger, Stavanger Universitetssykehus
        • Kontakt:
  • Polen
      • Warsaw, Polen, 04 141
        • Rekruttering
        • Military Medical Institute- National Research Institute
        • Kontakt:
      • Wroclaw, Polen, 50-566
        • Rekruttering
        • Cityclinic Medical and Psychological Clinic Matusiak Partnership
        • Kontakt:
  • Portugal
      • Coimbra, Portugal, 3004-561
        • Rekruttering
        • CHUC - Centro Hospitalar e Universitario de Coimbra, EPE
        • Kontakt:
      • Lisbon, Portugal, 1649-035
      • Lisbon, Portugal, 1169-050
        • Rekruttering
        • ULS de São José, E.P.E. - Hospital Sto. António Capuchos
        • Kontakt:
      • Porto, Portugal, 4099-001
        • Rekruttering
        • ULS de Santo Antônio, E.P.E - Centro Hospitalar Universitário de Santo António
        • Kontakt:
  • Schweiz
      • Zurich, Schweiz, 8091
        • Rekruttering
        • University Hospital Zurich
        • Kontakt:
  • Spanien
      • Barcelona, Spanien, 08003
      • Madrid, Spanien, 28046
        • Rekruttering
        • Hospital Universitario La Paz
        • Kontakt:
      • Madrid, Spanien, 28034
        • Rekruttering
        • Hospital Universitario Ramon Y Cajal
        • Kontakt:
      • Málaga, Spanien, 29010
        • Rekruttering
        • Hospital Universitario Virgen de la Victoria
        • Kontakt:
  • Sverige
      • Stockholm, Sverige, 17176
        • Rekruttering
        • Karolinska Universitetssjukhuset Solna
        • Kontakt:
  • Taiwan
      • Kaohsiung City, Taiwan, 83301
        • Rekruttering
        • Kaohsiung Chang Gung Memorial Hospital
        • Kontakt:
      • Linkou District, Taiwan, 333
        • Rekruttering
        • Chang Gung Medical Foundation (CGMF) - Linkou Bran
        • Kontakt:
      • Taipei, Taiwan, 100
        • Rekruttering
        • National Taiwan University Hospital
        • Kontakt:
  • Tyskland
      • Berlin, Tyskland, 10117
      • Düsseldorf, Tyskland, 40225
        • Ikke rekrutterer endnu
        • Universitätsklinikum Düsseldorf
        • Kontakt:
      • Erlangen, Tyskland, 91054
      • Essen, Tyskland, 45147
      • Freiburg im Breisgau, Tyskland, 79104
      • Hamburg, Tyskland, 20246
        • Rekruttering
        • Universitätsklinikum Hamburg, Eppendorf
        • Kontakt:
      • Tübingen, Tyskland, 72076
        • Ikke rekrutterer endnu
        • Universitätsklinikum Tübingen
        • Kontakt:
      • Würzburg, Tyskland, 97080
  • Østrig
      • Graz, Østrig, 8036
      • Salzburg, Østrig, 5020

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Placebo komparator: Placebo
Medicin: Prednisone

Prednisone

Medicin: Prednisolone

Prednisolone

Medicin: Placebo matching to spesolimab

Placebo matching to spesolimab
Eksperimentel: Spesolimab
Medicin: Spesolimab

Solution for infusion

Medicin: Prednisone

Prednisone

Medicin: Prednisolone

Prednisolone

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
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)
Tidsramme: 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.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

LEO Pharma

Samarbejdspartnere

Boehringer Ingelheim

Efterforskere

  • Studieleder: Medical Expert, LEO Pharma

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

5. februar 2025

Primær færdiggørelse (Anslået)

12. november 2027

Studieafslutning (Anslået)

19. august 2028

Datoer for studieregistrering

Først indsendt

30. september 2024

Først indsendt, der opfyldte QC-kriterier

30. september 2024

Først opslået (Faktiske)

3. oktober 2024

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

9. november 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

6. november 2026

Sidst verificeret

1. november 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

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

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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