Phase III Trial to Investigate Efficacy and Safety of Vilobelimab in Ulcerative Pyoderma Gangrenosum

November 2, 2025 updated by: InflaRx GmbH

A Randomized, Double-blind, Placebo-controlled, Multicenter, Adaptive Phase III Trial to Investigate Efficacy and Safety of Vilobelimab in the Treatment of Ulcerative Pyoderma Gangrenosum

A randomized, double-blind, placebo-controlled, multicenter, adaptive phase III trial to investigate efficacy and safety of vilobelimab in the treatment of ulcerative pyoderma gangrenosum

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
54

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Australia
      • Brisbane, Australia
        • Veracity Clinical Research Pty Ltd as trustee for the MLS Trust
      • Sydney, Australia
        • Liverpool Hospital
    • NewSouth Wales
      • Kogarah, NewSouth Wales, Australia
        • Premier Specialists
    • Victoria
      • Melbourne, Victoria, Australia, 3004
        • The Alfred Hospital, Melbourne
  • Belgium
      • Anderlecht, Belgium
        • Hôpitaux Universitaires de Bruxelles
      • Brussels, Belgium
        • Cliniques universitaires Saint-Luc
  • France
      • Lyon, France, 69003
        • Hospital Edouard Herriot
      • Nantes, France, 44093
        • CHU de Nantes - Clinique dermatologique
      • Paris, France, 75010
        • Saint Louis Hospital
    • Occitanie
      • Toulouse, Occitanie, France, 31000
        • CHU Toulouse Hospital Larrey
  • Germany
      • Berlin, Germany
        • Charité - Universitätsmedizin Berlin, Department of Dermatology, Venereology and Allergology, Berlin, Germany
      • Düsseldorf, Germany
        • University clinic Duesseldorf Department of Dermatology Heinrich-Heine-University Duesseldorf
      • Halle, Germany
        • Universitätsklinik für Dermatologie und Venerologie der MLU Halle
      • Hamburg, Germany
        • Universitätsklinikum Hamburg-Eppendorf, Institut für Versorgungsforschung in der Dermatologie und bei Pflegeberufen (IVDP)
      • Leipzig, Germany
        • University Hospital Leipzig AöR
    • Baden Würrtemberg
      • Tübingen, Baden Würrtemberg, Germany, 72076
        • Universitätshautklinik Tübingen
    • Bavaria
      • Erlangen, Bavaria, Germany, 91054
        • Berge Hautklinik
      • Heidelberg, Bavaria, Germany, 69120
        • Universitatsklinikum Heidelberg
      • München, Bavaria, Germany, 80337
        • Klinik und Poliklinik für Dermatologie und Allergologie
      • Würzburg, Bavaria, Germany, 97080
        • University Hospital Würzburg, Department of Dermatology
    • Hesse
      • Frankfurt am Main, Hesse, Germany, 60590
        • Universitätsklinikum Frankfurt, Klinik für Dermatologie
    • Nordrhein-Westfalia
      • Bochum, Nordrhein-Westfalia, Germany, 44791
        • Catholic Clinic Bochum, Department of Dermatology
    • North Rhine-Westphalia
      • Essen, North Rhine-Westphalia, Germany
        • University of Essen, Germany
  • Hungary
      • Pécs, Hungary
        • Department of Dermatology, Venerology and Oncodermatology, University of Pécs
    • Csongrad-Csanad
      • Szeged, Csongrad-Csanad, Hungary, 6720
        • Department of Dermatology and Allergology, University of Szeged
    • Hadju-Bihar
      • Debrecen, Hadju-Bihar, Hungary, 4032
        • Department of Dermatology, University of Debrecen
  • Italy
      • Bologna, Italy
        • IRCCS Policlinico di Sant'Orsola Alma Mater Studiorum - University of Bologna
      • Milan, Italy, 20122
        • Fondazione IRCCS Ca´ Granda Ospedale Maggiore Policlinico SC Dermatologia
      • Pisa, Italy, 56126
        • Ospedale Santa Chiara
      • Turin, Italy
        • AOU Città della Salute e della Scienza
  • Poland
      • Lodz, Poland
        • Wojewódzki Specjalistyczny Szpital im. Dr Wł. Biegańskiego w Łodzi; Klinika Dermatologii, Dermatologii Dziecięcej i Onkologicznej Uniwersytetu Medycznego
      • Lublin, Poland
        • Department and Clinics of Dermatology, Venereology and Paediatric Dermatology, Medical University of Lublin,
      • Olsztyn, Poland
        • Klinika Dermatologii, Chorób Przenoszonych Drogą Płciową i Immunologii Klininczej, Miejski Szpital Zespolony w Olsztynie Clinic of Dermatology,
      • Warsaw, Poland
        • Państwowy Instytut Medyczny CSK MSWiA
      • Wroclaw, Poland
        • City Clinic Przychodnia Lekarsko-Psychologiczna ul. Sliczna 13, Wroclaw, Poland
  • Spain
      • Madrid, Spain, 28034
        • Hospital Ramon y Cajal
      • Salamanca, Spain
        • Complejo Asistencial Universitario de Salamanca
  • Switzerland
      • Basel, Switzerland
        • University Hospital Basel Department of Dermatology at Universitäre Altersmedizin FELIX PLATTER
  • United States
    • Florida
      • Hialeah, Florida, United States, 33016
        • Aby´s New Generation Research, Inc
      • Miami, Florida, United States, 33146
        • Dermatology/University of Miami Hospital
      • Orlando, Florida, United States, 32827
        • University of Central Florida College of Medicine
      • Tampa, Florida, United States, 33613
        • ForCare Clinical Research
    • Georgia
      • Sandy Springs, Georgia, United States, 30328
        • Advanced Medical Research, PC
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women´s Hospital
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27516
        • University of North Carolina at Chapel Hill Department of Dermatology
    • Ohio
      • Columbus, Ohio, United States, 43215
        • Ohio State University Wexner Medical Cente OSU Dermatology West
      • Mayfield Heights, Ohio, United States, 44124
        • Apex Clinical Research Center
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health and Science University
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19194
        • University of Pennsylvania
    • Texas
      • Bellaire, Texas, United States, 77401
        • The University of Texas Health Science Center at Houston

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Main Inclusion Criteria:

  1. 18 years or older at the time of signing the informed consent.
  2. Investigator confirmed clinical diagnosis of ulcerative PG. Diagnosis shall be supported by clinical assessment of PG symptoms via PARACELSUS score (Jockenhofer, Wollina et al. 2019) of 10 points or more (see Appendix - Section 12.1). Note: in case of PARACELSUS score < 10, additional justification shall be provided by the investigator to support clinical diagnosis of ulcerative PG.

  3. Minimum of 1 evaluable PG ulcer (other than peristomal) which qualifies as the target ulcer by meeting the following criteria (Orfaly, Reese et al. 2022): area of ≥ 5 cm 2 at screening and baseline

    • circulated by intact skin
    • evaluable by at least 2-dimensional measurement

Main Exclusion Criteria:

  1. Patients with target ulcers exceeding 80 cm 2 .
  2. Patients with target ulcer in transplanted skin.
  3. Surgical wound debridement or negative pressure wound therapy (NPWT) for the target ulcer within 4 weeks before baseline (i.e., start of treatment with IMP).
  4. Patient with previous exposure to vilobelimab (IFX-1) prior to baseline (i.e., start of treatment with IMP).
  5. Patient receives/has received a vaccine within 2 weeks prior to baseline (i.e., start of treatment with IMP).
  6. Any active infection requiring systemic antibiotic or other systemic treatment or suppressive anti-infective therapy within 2 weeks prior to baseline (i.e., start of treatment with IMP).
  7. Patients received any systemic medical treatment for PG within 4 weeks prior to baseline
  8. Patients received any biological or immunomodulatory therapy for PG within 4 weeks prior to baseline (i.e., start of treatment with IMP), except existing biologic or immunomodulatory therapy used for an underlying disease (other than PG at a stable therapy with no dose adjustments for at least two maintenance doses prior to screening this is allowed to be continued.
  9. Patients receiving corticosteroids treatment for PG of more than 10 mg/day of prednisone or equivalent within 4 weeks prior to baseline (i.e., start of treatment with IMP).

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: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: vilobelimab
Patients will be treated with vilobelimab IV, Q2W for 26 weeks
Drug: vilobelimab
vilobelimab infusion
Placebo Comparator: Placebo
Patients will receive placebo IV in the same schedule as patients in Arm 1
Drug: Placebo
Placebo Infusion

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Efficacy of treatment with vilobelimab compared to placebo
Time Frame: Week 1 to Week 26
Efficacy of Vilobelimab compared to placebo - complete closure of the ulcer
Week 1 to Week 26

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Efficacy of treatment with vilobelimab compared to placebo
Time Frame: 2 weeks between study visits
Proportion of patients achieving disease remission up to and including EOT visit; where disease remission is assessed by the investigator as complete re-epithelization (defined as wound covered by epithelial skin layer or scar) of all PG ulcers, without drainage or dressing requirements
2 weeks between study visits
Pain reduction
Time Frame: Week 10 through study completion
Proportion of patients achieving a pain reduction related to the target ulcer of at least 3 points compared to baseline
Week 10 through study completion

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
InflaRx GmbH

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Alex GO Loayza, Prof, MD, University

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 11, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 11, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 29, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 24, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 27, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 4, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 2, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IFX-1-P3.4

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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