Clinical trial • Dermatology

SPESOLIMAB for Pyoderma gangrenosum

Clinical trial of SPESOLIMAB for Pyoderma gangrenosum.

Overview

Trial Therapeutic Area
Dermatology
Trial Disease
Pyoderma gangrenosum
Drug Modality
Monoclonal antibody

Key dates

Initial CTIS Submission Date
29-08-2024
First CTIS Authorization Date
18-12-2024

Trial design

Randomised, placebo matching to spesolimab (placebo arm; dose/schedule not specified in available documents)-controlled trial in Austria, Belgium, Finland and others.

Randomised
Yes
Comparator
Placebo matching to spesolimab (placebo arm; dose/schedule not specified in available documents)
Target Sample Size
59
Trial Duration For Participant
364

Eligibility

Recruits 59 No vulnerable populations selected; participants are adults (aged ≥18). Informed consent: '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.'.

Vulnerable Population
No vulnerable populations selected; participants are adults (aged ≥18). Informed consent: '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.'

Inclusion criteria

  • {"criterion_text":"-Adult trial participants, aged ≥18 years (if local legislation for age of consent differs, then local legislation will be followed) at screening."}
  • {"criterion_text":"-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."}
  • {"criterion_text":"-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."}
  • {"criterion_text":"-At least one measurable (defined as measuring ≥5 cm2) 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."}
  • {"criterion_text":"-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."}
  • {"criterion_text":"-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 Section 4.2.2.3 of the protocol."}

Exclusion criteria

  • {"criterion_text":"-Trial participants with non-PG lesions."}
  • {"criterion_text":"-Trial participants with a target PG ulcer measuring >80 cm2."}
  • {"criterion_text":"-Trial participants with chronic, non-inflamed PG wounds or ulcers that are not responsive to immunosuppressive therapy, as determined by an Adjudication Committee."}
  • {"criterion_text":"-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."}
  • {"criterion_text":"-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."}
  • {"criterion_text":"-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."}
  • {"criterion_text":"-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."}
  • {"criterion_text":"-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."}
  • {"criterion_text":"-Further exclusion criteria apply."}

Endpoints

Primary endpoints

  • {"endpoint_text":"-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)","definition_or_measurement_approach":"Complete closure defined as PGAR-100 (100% pyoderma gangrenosum area reduction) of the target PG ulcer at any time up to Week 26; must be confirmed at the next consecutive visit at least 2 weeks later."}

Secondary endpoints

  • {"endpoint_text":"-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)","definition_or_measurement_approach":"PGAR-100 of the target ulcer assessed at Week 26 and confirmation at the next consecutive visit (≥2 weeks later)."}
  • {"endpoint_text":"-Achievement of 50% area reduction (PGAR-50) of the target PG ulcer at any time up to Week 26","definition_or_measurement_approach":"PGAR-50 defined as 50% reduction in target ulcer area at any time up to Week 26."}
  • {"endpoint_text":"-Achievement of ≥ 3 point reduction in NRS Pain score from baseline at Week 26","definition_or_measurement_approach":"Reduction of at least 3 points on the Numeric Rating Scale (NRS) for pain from baseline to Week 26."}
  • {"endpoint_text":"-Achievement of a DLQI of ≤ 5 at Week 26","definition_or_measurement_approach":"Dermatology Life Quality Index (DLQI) score ≤5 measured at Week 26."}
  • {"endpoint_text":"-Achievement of PGAR-100 of any measurable PG ulcer (≥5 cm2 at baseline) at any time up to Week 26 and confirmed at the next consecutive visit (at least 2 weeks later)","definition_or_measurement_approach":"PGAR-100 for any measurable ulcer (≥5 cm2 at baseline), confirmation at next visit (≥2 weeks)."}
  • {"endpoint_text":"-Achievement of PGAR-100 of all measurable PG ulcers (≥5 cm2 at baseline) at any time up to Week 26 and confirmed at the next consecutive visit (at least 2 weeks later)","definition_or_measurement_approach":"PGAR-100 for all measurable ulcers (≥5 cm2 at baseline), confirmed at next visit (≥2 weeks)."}
  • {"endpoint_text":"-Time to recurrence among trial participants who had achieved complete response (CR, complete closure of all PG ulcers) at Week 26 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)","definition_or_measurement_approach":"Time-to-event endpoint measured from time of complete response to recurrence up to Week 52; recurrence defined as re-emergence at prior sites or new PG ulcers."}

Recruitment

Planned Sample Size
59
Recruitment Window Months
32
Consent Approach
Signed and dated written informed consent required from each participant in accordance with ICH-GCP and local legislation prior to admission. Participants are adults (≥18). Country-specific participant information and ICFs are provided (multiple language versions available across participating countries, including English, German, French, Dutch, Spanish, Italian, Portuguese, Finnish, Swedish, Polish as reflected by published ICF documents).

Geography

Total Number Of Sites
33
Total Number Of Participants
34

Austria

Earliest CTIS Part Ii Submission Date
28-11-2024
Latest Decision Or Authorization Date
04-08-2025
Processing Time Days
249
Number Of Sites
3
Number Of Participants
2

Sites

Site Name
Medical University Of Graz
Department Name
Univ.-Klinik f. Dermatologie und Venerologie
Contact Person Name
Peter Wolf
Contact Person Email
peter.wolf@medunigraz.at
Site Name
Clinical Research Center Salzburg GmbH
Department Name
Universitätsklinik für Dermatologie und Allergologie
Contact Person Name
Martin Laimer
Contact Person Email
m.laimer@salk.at
Site Name
Johannes Kepler University Linz
Department Name
University Clinic for Dermatology and Venereology
Contact Person Name
Wolfram Hoetzenecker

Belgium

Earliest CTIS Part Ii Submission Date
25-11-2024
Latest Decision Or Authorization Date
30-07-2025
Processing Time Days
247
Number Of Sites
1
Number Of Participants
2

Sites

Site Name
UZ Leuven
Contact Person Name
An Van Laethem
Contact Person Email
an.vanlaethem@uzleuven.be

Finland

Earliest CTIS Part Ii Submission Date
25-11-2024
Latest Decision Or Authorization Date
30-07-2025
Processing Time Days
247
Number Of Sites
1
Number Of Participants
5

Sites

Site Name
HUS-Yhtymae
Department Name
HUS Tulehduskeskus /Ihosairauksien linja
Contact Person Name
Kirsi Isoherranen
Contact Person Email
kirsi.isoherranen@hus.fi

France

Earliest CTIS Part Ii Submission Date
16-10-2024
Latest Decision Or Authorization Date
30-07-2025
Processing Time Days
287
Number Of Sites
3
Number Of Participants
2

Sites

Site Name
Assistance Publique Hopitaux De Paris
Department Name
Service de Dermatologie
Contact Person Name
Jean-David Bouaziz
Contact Person Email
jean-david.bouaziz@aphp.fr
Site Name
Hopital Prive D Antony
Department Name
Unité de Dermatologie et Immunologie Clinique
Contact Person Name
Pierre-André Becherel
Site Name
Centre Hospitalier Universitaire De Nice
Department Name
Service de Dermatologie
Contact Person Name
Thierry Passeron
Contact Person Email
passeron.t@chu-nice.fr

Italy

Earliest CTIS Part Ii Submission Date
13-09-2024
Latest Decision Or Authorization Date
04-08-2025
Processing Time Days
325
Number Of Sites
7
Number Of Participants
5

Sites

Site Name
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Department Name
UO Dermatologia
Contact Person Name
Angelo Marzano
Contact Person Email
angelo.marzano@unimi.it
Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
U.O.C. di Dermatologia
Contact Person Name
Ketty Peris
Contact Person Email
ketty.peris@unicatt.it
Site Name
Azienda Ospedaliero Universitaria Pisana
Department Name
Dipartimento di Area Medica e Oncologica
Contact Person Name
Marco Romanelli
Contact Person Email
marco.romanelli@unipi.it
Site Name
I.F.O. Istituti Fisioterapici Ospitalieri
Department Name
UOSD Porfirie e Malattie Rare
Contact Person Name
Miriam Teoli
Contact Person Email
miriam.teoli@ifo.it
Site Name
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
Department Name
Dermatologia U
Contact Person Name
Simone Ribero
Contact Person Email
simone.ribero@unito.it
Site Name
Humanitas Mirasole S.p.A.
Department Name
U.O. Dermatologia
Contact Person Name
Antonio Costanzo
Contact Person Email
antonio.costanzo@hunimed.eu
Site Name
Azienda Ospedaliero-Universitaria Policlinico Umberto I
Department Name
U. O. C. Dermatologia
Contact Person Name
Giovanni Pellacani
Contact Person Email
pellacani.giovanni@gmail.com

Portugal

Earliest CTIS Part Ii Submission Date
31-10-2024
Latest Decision Or Authorization Date
30-07-2025
Processing Time Days
272
Number Of Sites
5
Number Of Participants
2

Sites

Site Name
CCAB Centro Clinico Academico Braga Associacao
Department Name
Serviço Dermatologia
Contact Person Name
Celeste Brito
Contact Person Email
celeste.brito@hb.min-saude.pt
Site Name
Unidade Local De Saude De Sao Jose E.P.E.
Department Name
Dermatologia
Contact Person Name
Cândida Fernandes
Site Name
Unidade Local De Saude De Coimbra E.P.E.
Department Name
Dermatology Department
Contact Person Name
Felicidade Santiago
Contact Person Email
felicidadesantiago@hotmail.com
Site Name
Unidade Local De Saude De Santo Antonio E.P.E.
Department Name
Dermatology Department
Contact Person Name
Tiago Torres
Site Name
Unidade Local De Saude De Santa Maria E.P.E.
Department Name
Serviço Dermatologia
Contact Person Name
Joana Antunes

Spain

Earliest CTIS Part Ii Submission Date
13-09-2024
Latest Decision Or Authorization Date
01-08-2025
Processing Time Days
322
Number Of Sites
2
Number Of Participants
2

Sites

Site Name
Hospital Universitario Virgen De La Victoria
Department Name
Servicio de Dermatología
Contact Person Name
Enrique Herrera
Contact Person Email
eherreraacosta@gmail.com
Site Name
Hospital Universitario Ramon Y Cajal
Department Name
Dermatología
Contact Person Name
Asunción Ballester
Contact Person Email
asun.ballester@gmail.com

Sweden

Earliest CTIS Part Ii Submission Date
13-09-2024
Latest Decision Or Authorization Date
30-07-2025
Processing Time Days
320
Number Of Sites
1
Number Of Participants
2

Sites

Site Name
Karolinska University Hospital
Department Name
Hudmottagningen A6:1
Contact Person Name
Åsa Krantz

Norway

Earliest CTIS Part Ii Submission Date
09-12-2024
Latest Decision Or Authorization Date
01-08-2025
Processing Time Days
235
Number Of Sites
2
Number Of Participants
3

Sites

Site Name
Helse Stavanger HF
Department Name
Forskningsposten
Contact Person Name
Inger Marie Skoie
Contact Person Email
inger.marie.skoie@sus.no
Site Name
Oslo University Hospital HF
Department Name
Klinisk Forskningspost
Contact Person Name
Olav Sundnes
Contact Person Email
olav.sundnes@medisin.uio.no

Poland

Earliest CTIS Part Ii Submission Date
22-11-2024
Latest Decision Or Authorization Date
04-08-2025
Processing Time Days
255
Number Of Sites
3
Number Of Participants
2

Sites

Site Name
Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy
Department Name
Dermatology Department
Contact Person Name
Agnieszka Terlikowska-Brzosko
Site Name
Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak sp.p.
Department Name
Private Practice
Contact Person Name
Jacek Szepietowski
Site Name
Miejski Szpital Zespolony W Olsztynie
Department Name
Dermatology, Sexually Transmitted Diseases and Clinical Immunology Clinic
Contact Person Name
Agnieszka Owczarczyk-Saczonek

Germany

Earliest CTIS Part Ii Submission Date
22-11-2024
Latest Decision Or Authorization Date
15-12-2025
Processing Time Days
388
Number Of Sites
5
Number Of Participants
7

Sites

Site Name
Medical Center - University Of Freiburg
Department Name
Klinik für Dermatologie und Venerologie
Contact Person Name
Franziska Schauer
Site Name
Universitaetsklinikum Erlangen AöR
Department Name
Hautklinik
Contact Person Name
Lukas Sollfrank
Contact Person Email
Lukas.Sollfrank@uk-erlangen.de
Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Klinik für Dermatologie, Venerologie und Allergologie
Contact Person Name
Kamran Ghoreschi
Contact Person Email
kamran.ghoreschi@charite.de
Site Name
Universitaetsklinikum Wuerzburg AöR
Department Name
Klinik und Poliklinik für Dermatologie, Venerologie und Allergologie
Contact Person Name
Andreas Kerstan
Contact Person Email
kerstan_a@ukw.de
Site Name
Universitaetsklinikum Essen AöR
Department Name
Klinik für Dermatologie, Venerologie und Allergologie
Contact Person Name
Joachim Dissemond
Contact Person Email
Joachim.Dissemond@uk-essen.de

Sponsor

Primary sponsor

Full Name
Boehringer Ingelheim International GmbH
Organisation Type
Pharmaceutical company
Country Of Registered Address
Germany

Third parties

  • {"country":"Spain","full_name":"Boehringer Ingelheim Espana S.A.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}

Co-sponsors

  • Boehringer Ingelheim Espana S.A.

Investigational products

Investigational Product Name
Spesolimab (BI 655130)
Active Substance
SPESOLIMAB
Modality
Monoclonal antibody
Routes Of Administration
Intravenous
Route
Intravenous
Investigational Product Name
Placebo matching to spesolimab
Modality
Other

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