Cette page a été traduite automatiquement et l'exactitude de la traduction n'est pas garantie. Veuillez vous référer au version anglaise pour un texte source.

Une étude pour tester si le spésolimab aide les personnes atteintes d'une maladie cutanée appelée Pyoderma Gangrenosum

6 novembre 2026 mis à jour par: LEO Pharma

Un essai multicentrique, randomisé, contrôlé par placebo, en double aveugle, en groupes parallèles pour évaluer l'innocuité et l'efficacité du spésolimab (BI 655130) chez les patients adultes atteints de pyodermite gangrenosum ulcéreuse (PG) qui nécessitent un traitement systémique

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.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Estimé)

90

Phase

  • Phase 3

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Double

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur placebo: Placebo
Médicament: Prednisone

Prednisone

Médicament: Prednisolone

Prednisolone

Médicament: Placebo matching to spesolimab

Placebo matching to spesolimab
Expérimental: Spesolimab
Médicament: Spesolimab

Solution for infusion

Médicament: Prednisone

Prednisone

Médicament: Prednisolone

Prednisolone

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
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)
Délai: 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.

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
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)
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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.

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

LEO Pharma

Collaborateurs

Boehringer Ingelheim

Les enquêteurs

  • Directeur d'études: Medical Expert, LEO Pharma

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

5 février 2025

Achèvement primaire (Estimé)

12 novembre 2027

Achèvement de l'étude (Estimé)

19 août 2028

Dates d'inscription aux études

Première soumission

30 septembre 2024

Première soumission répondant aux critères de contrôle qualité

30 septembre 2024

Première publication (Réel)

3 octobre 2024

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

9 novembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

6 novembre 2026

Dernière vérification

1 novembre 2026

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 1368-0140
  • U1111-1306-8055 (Identificateur de registre: World Health Organization (WHO))
  • 2024-514306-31-00 (Ctis)

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Oui

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

S'abonner