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

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Alex GO Loayza, Prof, MD; Phone Number: +49 89 414 189 78 00
• Study Contact Backup: Name: Dorothee Neukirchen, Dr.; Phone Number: +49 89 4141897800; Email: clinicaltrials@inflarx.de

Study Locations

• Australia
  • Brisbane, Australia, 4102
    • Recruiting
    • Veracity Clinical Research Center
  • New South Wales
    • Kogarah, New South Wales, Australia, 2217
      • Recruiting
      • Premier Specialists
  • Victoria
    • Melbourne, Victoria, Australia, 3004
      • Recruiting
      • The Alfred Hospital, Melbourne
• France
  • Lyon, France, 69003
    • Recruiting
    • Hospital Edouard Herriot
  • Paris, France, 75010
    • Recruiting
    • Saint Louis Hospital
  • Loire- Atlantique
    • Nantes, Loire- Atlantique, France, 44093
      • Recruiting
      • CHU des Nantes
  • Occitanie
    • Toulouse, Occitanie, France, 31000
      • Recruiting
      • CHU Toulouse Hospital Larrey
• Germany
  • Berlin, Germany, 10117
    • Recruiting
    • Charite Universitatsmedizin Berlin
  • Baden Würrtemberg
    • Tübingen, Baden Würrtemberg, Germany, 72076
      • Recruiting
      • Universitätshautklinik Tübingen
  • Bavaria
    • Erlangen, Bavaria, Germany, 91054
      • Recruiting
      • Berge Hautklinik
    • Heidelberg, Bavaria, Germany, 69120
      • Recruiting
      • Universitätsklinikum Heidelberg
    • München, Bavaria, Germany, 80337
      • Recruiting
      • Klinik und Poliklinik für Dermatologie und Allergologie
    • Würzburg, Bavaria, Germany, 97080
      • Recruiting
      • University Hospital Würzburg, Department of Dermatology
  • Hessen
    • Frankfurt, Hessen, Germany, 60590
      • Recruiting
      • Universitätsklinikum Frankfurt, Klinik für Dermatologie
  • Nordrhein-Westfalia
    • Bochum, Nordrhein-Westfalia, Germany, 44791
      • Recruiting
      • Catholic Clinic Bochum, Department of Dermatology
• Hungary
  • Baranya
    • Pécs, Baranya, Hungary, 7632
      • Recruiting
      • Department of Dermatology and Venerology and Oncodermatology, University of Pecs
  • Csongrad-Csanad
    • Szeged, Csongrad-Csanad, Hungary, 6720
      • Recruiting
      • Department of Dermatology and Allergology, University of Szeged
  • Hadju-Bihar
    • Debrecen, Hadju-Bihar, Hungary, 4032
      • Recruiting
      • Department of Dermatology, University of Debrecen
• Italy
  • Milan, Italy, 20122
    • Recruiting
    • Fondazione IRCCS Ca´ Granda Ospedale Maggiore Policlinico SC Dermatologia
  • Pisa, Italy, 56124
    • Recruiting
    • University of Pisa, Santa Chiara Hospital
• Poland
  • Lower Silesia
    • Wrocław, Lower Silesia, Poland, 50-566
      • Recruiting
      • City Clinic Lekarsko Psychologiczna ul. Sliczna 13, Wroclaw
  • Mazowsze
    • Warsaw, Mazowsze, Poland, 02-507
      • Recruiting
      • Paistowny Instytut Mediczny CSK
  • Warminsko
    • Olsztyn, Warminsko, Poland, 10229
      • Recruiting
      • Clinic of Dermatology, Transmitted Diseases and Clinical Immunology
• Spain
  • Salamanca, Spain, 37007
    • Recruiting
    • Complejo Asistencial Universitario de Salamanca
• Switzerland
  • Basel, Switzerland, 4055
    • Recruiting
    • University Hospital Basel
• United States
  • Florida
    • Hialeah, Florida, United States, 33016
      • Recruiting
      • Aby´s New Generation Research, Inc
    • Tampa, Florida, United States, 33613
      • Recruiting
      • Forcare Clinical Research
  • Georgia
    • Sandy Springs, Georgia, United States, 30328
      • Recruiting
      • Advanced Medical Research, PC
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Recruiting
      • Brigham and Women´s Hospital
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27516
      • Recruiting
      • University of North Carolina at Chapel Hill Department of Dermatology
  • Ohio
    • Columbus, Ohio, United States, 432115
      • Recruiting
      • Ohio State University
    • Ohio City, Ohio, United States, 44124
      • Recruiting
      • Apex Clinical Research Center
  • Oregon
    • Portland, Oregon, United States, 97239
      • Recruiting
      • Oregon Health and Science University

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

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2023
• Primary Completion (Estimated): February 13, 2026
• Study Completion (Estimated): May 15, 2026

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 (Actual): March 4, 2024
• Last Update Submitted That Met QC Criteria: March 1, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Ulcer; Skin Diseases, Vascular; Pyoderma; Pyoderma Gangrenosum; Physiological Effects of Drugs; Immunosuppressive Agents; Immunologic Factors; 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