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Uno studio per verificare se Spesolimab aiuta le persone con una condizione della pelle chiamata pioderma gangrenoso

6 novembre 2026 aggiornato da: LEO Pharma

Uno studio multicentrico, randomizzato, controllato con placebo, in doppio cieco, a gruppi paralleli per valutare la sicurezza e l'efficacia di spesolimab (BI 655130) in pazienti adulti con pioderma gangrenoso (PG) ulceroso che richiedono terapia sistemica

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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

90

Fase

  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore placebo: Placebo
Droga: Prednisone

Prednisone

Droga: Prednisolone

Prednisolone

Droga: Placebo matching to spesolimab

Placebo matching to spesolimab
Sperimentale: Spesolimab
Droga: Spesolimab

Solution for infusion

Droga: Prednisone

Prednisone

Droga: Prednisolone

Prednisolone

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
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)
Lasso di tempo: 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.

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

LEO Pharma

Collaboratori

Boehringer Ingelheim

Investigatori

  • Direttore dello studio: Medical Expert, LEO Pharma

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

5 febbraio 2025

Completamento primario (Stimato)

12 novembre 2027

Completamento dello studio (Stimato)

19 agosto 2028

Date di iscrizione allo studio

Primo inviato

30 settembre 2024

Primo inviato che soddisfa i criteri di controllo qualità

30 settembre 2024

Primo Inserito (Effettivo)

3 ottobre 2024

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

9 novembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

6 novembre 2026

Ultimo verificato

1 novembre 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 1368-0140
  • U1111-1306-8055 (Identificatore di registro: World Health Organization (WHO))
  • 2024-514306-31-00 (Ctis)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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