Phase III Trial to Investigate Efficacy and Safety of Vilobelimab in 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

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: Terminated
• Conditions: Pyoderma Gangrenosum
• Intervention / Treatment: Drug: Placebo; Drug: vilobelimab

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Phase 3

Contacts and Locations

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
      • Universitätsklinikum Heidelberg
    • München, Bavaria, Germany, 80337
      • Klinik und Poliklinik fur 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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Efficacy of treatment with vilobelimab compared to placebo	Efficacy of Vilobelimab compared to placebo - complete closure of the ulcer	Week 1 to Week 26

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy of treatment with vilobelimab compared to placebo	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	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

• Sponsor: InflaRx GmbH
• Investigators: Principal Investigator: Alex GO Loayza, Prof, MD, University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2023
• Primary Completion (Actual): July 11, 2025
• Study Completion (Actual): July 11, 2025

Study Registration Dates

• First Submitted: June 29, 2023
• First Submitted That Met QC Criteria: July 24, 2023
• First Posted (Actual): July 27, 2023

Study Record Updates

• Last Update Posted (Estimated): November 4, 2025
• Last Update Submitted That Met QC Criteria: November 2, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Ulcer; Skin Diseases, Vascular; Skin and Connective Tissue Diseases; Pyoderma; Pyoderma Gangrenosum; Immunosuppressive Agents; Immunologic Factors; Physiological Effects of Drugs; Complement Inactivating Agents; vilobelimab
• Other Study ID 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