A Study to Test Whether Spesolimab Helps People With a Skin Condition Called Pyoderma Gangrenosum

May 27, 2026 updated by: Boehringer Ingelheim

A Multi-centre, Randomised, Placebo-controlled, Double-blind, Parallel-group Trial to Evaluate Safety and Efficacy of Spesolimab (BI 655130) in Adult Patients With Ulcerative Pyoderma Gangrenosum (PG) Who Require Systemic Therapy

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Argentina
      • CABA, Argentina, 1602
        • Completed
        • CIPREC
      • CABA, Argentina, C1056AB
        • Completed
        • Hospital Italiano de Buenos Aires
      • Rosario, Argentina, 2000
        • Completed
        • Instituto de Especialidades de la Salud Rosario
  • Australia
    • New South Wales
      • Darlinghurst, New South Wales, Australia, 2010
      • St Leonards, New South Wales, Australia, 2065
        • Recruiting
        • Royal North Shore Hospital-St Leonards-20807
        • Contact:
      • Westmead, New South Wales, Australia, 2145
    • Victoria
      • Melbourne, Victoria, Australia, 3004
  • Austria
      • Graz, Austria, 8036
      • Salzburg, Austria, 5020
  • Belgium
  • Brazil
      • Brasília, Brazil, 72145-450
        • Recruiting
        • Chronos Pesquisa Clínica
        • Contact:
      • Santo André, Brazil, 09060-870
        • Not yet recruiting
        • Faculdade de Medicina do ABC
        • Contact:
  • Canada
      • Québec, Canada, G1W 4R4
        • Not yet recruiting
        • Centre de Recherche Saint-Louis
        • Contact:
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2B7
        • Not yet recruiting
        • University of Alberta Hospital (University of Alberta)
        • Contact:
      • Edmonton, Alberta, Canada, T5J 3S9
        • Recruiting
        • Rejuvenation Dermatology Clinic
        • Contact:
    • Ontario
      • Toronto, Ontario, Canada, M5S 1B2
        • Recruiting
        • Women's College Hospital
        • Contact:
    • Quebec
      • Montreal, Quebec, Canada, H4A 3J1
        • Recruiting
        • McGill University Health Centre (MUHC)
        • Contact:
  • China
      • Beijing, China, 100191
        • Recruiting
        • Peking University Third Hospital
        • Contact:
      • Beijing, China, 100044
        • Recruiting
        • Peking University People's Hospital
        • Contact:
      • Changchun, China, 130000
        • Recruiting
        • The First Hospital of Jilin University
        • Contact:
      • Changsha, China, 410011
        • Recruiting
        • The second Xiangya hospital of central south university
        • Contact:
      • Chengdu, China, 610041
        • Recruiting
        • West China Hospital, Sichuan University
        • Contact:
      • Hangzhou, China, 310003
        • Recruiting
        • The First Affiliated Hospital, Zhejiang University
        • Contact:
      • Hangzhou, China, 310009
        • Recruiting
        • The Second Affiliated Hospital Zhejiang University School of Medicine
        • Contact:
      • Hangzhou, China, 310013
        • Not yet recruiting
        • Hangzhou Third People's Hospital
        • Contact:
      • Jinan, China, 250063
        • Recruiting
        • Shandong Provincial Hospital of Dermatology
        • Contact:
      • Shanghai, China, 200000
        • Recruiting
        • Shanghai skin disease hospital
        • Contact:
      • Shenzhen, China, 518053
        • Recruiting
        • The University of Hong Kong-Shenzhen Hospital
        • Contact:
      • Wuhan, China, 430022
        • Not yet recruiting
        • Wuhan Union Hospital
        • Contact:
      • Xi'an, China, 710004
        • Recruiting
        • Second Affiliated Hospital of Xi'an JiaoTong University
        • Contact:
  • Finland
      • Helsinki, Finland, 00029
        • Not yet recruiting
        • HUS Tulehduskeskus /Ihosairauksien linja
        • Contact:
  • France
      • Antony, France, 92160
      • Lyon, France, 69437
        • Not yet recruiting
        • Hôpital Edouard Herriot
        • Contact:
      • Nice, France, 06200
        • Not yet recruiting
        • Hôpital de l'Archet
        • Contact:
      • Paris, France, 75010
  • Germany
      • Berlin, Germany, 10117
        • Not yet recruiting
        • Charité - Universitätsmedizin Berlin
        • Contact:
      • Düsseldorf, Germany, 40225
      • Erlangen, Germany, 91054
      • Essen, Germany, 45147
      • Freiburg im Breisgau, Germany, 79104
      • Hamburg, Germany, 20246
        • Not yet recruiting
        • Universitätsklinikum Hamburg, Eppendorf
        • Contact:
      • Tübingen, Germany, 72076
      • Würzburg, Germany, 97080
        • Not yet recruiting
        • Universitätsklinikum Würzburg AÖR
        • Contact:
  • Italy
      • Milan, Italy, 20122
        • Recruiting
        • Fondazione IRCCS Ca'Granda-Ospedale Maggiore Policlinico
        • Contact:
      • Pisa, Italy, 56126
        • Recruiting
        • Azienda Ospedaliera Universitaria Pisana
        • Contact:
      • Roma, Italy, 00168
        • Not yet recruiting
        • Fondazione Policlinico Universitario Agostino Gemelli IRCCS
        • Contact:
      • Roma, Italy, 00128
        • Recruiting
        • Istituti Fisioterapici Ospitalieri
        • Contact:
      • Rozzano (MI), Italy, 20089
        • Not yet recruiting
        • Istituto Clinico Humanitas
        • Contact:
      • Torino, Italy, 10126
        • Not yet recruiting
        • Azienda Ospedaliera Universitaria Citta della Salute e della Scienza di Torino
        • Contact:
  • Japan
      • Aichi, Toyoake, Japan, 470-1192
        • Not yet recruiting
        • Fujita Health University Hospital
        • Contact:
      • Hokkaido, Sapporo, Japan, 060-8648
        • Not yet recruiting
        • Hokkaido University Hospital
        • Contact:
      • Hyogo, Nishinomiya, Japan, 663-8501
        • Not yet recruiting
        • Hyogo College of Medicine Hospital
        • Contact:
      • Mie, Tsu, Japan, 514-8507
        • Recruiting
        • Mie University Hospital
        • Contact:
      • Miyagi, Sendai, Japan, 980-8574
        • Recruiting
        • Tohoku University Hospital
        • Contact:
      • Tochigi, Shimotsuke, Japan, 329-0498
        • Recruiting
        • Jichi Medical University Hospital
        • Contact:
      • Tokyo, Itabashi-ku, Japan, 173-8610
        • Recruiting
        • Nihon University Itabashi Hospital
        • Contact:
      • Tokyo, Itabashi-ku, Japan, 173-8606
        • Recruiting
        • Teikyo University Hospital
        • Contact:
  • Malaysia
      • Ipoh, Malaysia, 30450
      • Kuching, Malaysia, 93586
      • Pulau Pinang, Malaysia, 10450
        • Recruiting
        • Hospital Pulau Pinang-Pulau Pinang-21953
        • Contact:
  • Norway
      • Oslo, Norway, 0372
        • Recruiting
        • Oslo universitetssykehus HF, Rikshospitalet
        • Contact:
      • Stavanger, Norway, N-4011
        • Recruiting
        • Helse Stavanger, Stavanger Universitetssykehus
        • Contact:
  • Poland
      • Warsaw, Poland, 04 141
        • Recruiting
        • Military Medical Institute- National Research Institute
        • Contact:
      • Wroclaw, Poland, 50-566
        • Recruiting
        • Cityclinic Medical and Psychological Clinic Matusiak Partnership
        • Contact:
  • Portugal
      • Coimbra, Portugal, 3004-561
        • Not yet recruiting
        • CHUC - Centro Hospitalar e Universitário de Coimbra, EPE
        • Contact:
      • Lisbon, Portugal, 1169-050
        • Not yet recruiting
        • ULS de São José, E.P.E. - Hospital Sto. António Capuchos
        • Contact:
      • Lisbon, Portugal, 1649-035
      • Porto, Portugal, 4099-001
        • Not yet recruiting
        • ULS de Santo Antônio, E.P.E - Centro Hospitalar Universitário de Santo António
        • Contact:
  • Spain
      • Barcelona, Spain, 08003
      • Madrid, Spain, 28034
        • Recruiting
        • Hospital Universitario Ramon y Cajal
        • Contact:
      • Madrid, Spain, 28046
        • Not yet recruiting
        • Hospital Universitario La Paz
        • Contact:
      • Málaga, Spain, 29010
        • Recruiting
        • Hospital Universitario Virgen de la Victoria
        • Contact:
  • Sweden
      • Stockholm, Sweden, 17176
        • Recruiting
        • Karolinska Universitetssjukhuset Solna
        • Contact:
  • Switzerland
      • Zurich, Switzerland, 8091
        • Recruiting
        • University Hospital Zurich
        • Contact:
  • Taiwan
      • Kaohsiung City, Taiwan, 83301
        • Recruiting
        • Kaohsiung Chang Gung Memorial Hospital
        • Contact:
      • Linkou District, Taiwan, 333
        • Recruiting
        • Chang Gung Medical Foundation (CGMF) - Linkou Bran
        • Contact:
      • Taipei, Taiwan, 100
        • Not yet recruiting
        • National Taiwan University Hospital
        • Contact:
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
    • Arizona
      • Phoenix, Arizona, United States, 85006
    • California
      • Irvine, California, United States, 92697
    • Florida
      • Miami, Florida, United States, 33136
      • Tampa, Florida, United States, 33612
    • Idaho
      • Meridian, Idaho, United States, 83646
    • Indiana
      • Indianapolis, Indiana, United States, 46250
        • Recruiting
        • Dawes Fretzin Clinical Research Group, LLC-Indianapolis -68995
        • Contact:
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03766
    • New York
      • Lake Success, New York, United States, 11042
      • New York, New York, United States, 10029
    • North Dakota
      • Fargo, North Dakota, United States, 58103
    • Ohio
      • Cleveland, Ohio, United States, 44195
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • The Ohio State University Wexner Medical Center
        • Contact:
    • Oregon
      • Portland, Oregon, United States, 97239
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
    • Texas
      • Lewisville, Texas, United States, 75056
    • Utah
      • Murray, Utah, United States, 84107
        • Recruiting
        • University of Utah Health MidValley Dermatology
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Prednisone
Prednisone
Drug: Prednisolone
Prednisolone
Drug: Placebo matching to spesolimab
Placebo matching to spesolimab
Experimental: Spesolimab
Drug: Prednisone
Prednisone
Drug: Spesolimab
Solution for infusion
Drug: Prednisolone
Prednisolone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Time Frame: 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.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Time Frame: 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 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)
Time Frame: 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)
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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.
Time to recurrence among trial participants who had achieved CR at Week 26 up to Week 52
Time Frame: 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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 4, 2025

Primary Completion (Estimated)

November 12, 2027

Study Completion (Estimated)

August 19, 2028

Study Registration Dates

First Submitted

September 30, 2024

First Submitted That Met QC Criteria

September 30, 2024

First Posted (Actual)

October 3, 2024

Study Record Updates

Last Update Posted (Actual)

May 29, 2026

Last Update Submitted That Met QC Criteria

May 27, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1368-0140
  • 2024-514306-31-00 (Registry Identifier: CTIS (EU))
  • U1111-1306-8055 (Registry Identifier: WHO International Clinical Trials Registry Platform (ICTRP))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).

For more details refer to:

https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing

IPD Sharing Time Frame

One year after the approval has been granted by major Regulatory Authorities and after the primary manuscript has been accepted for publication, or after termination of the development program.

IPD Sharing Access Criteria

For study documents -upon signing of a 'Document Sharing Agreement'. For study data -1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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