ClinicalTrials.gov

History of Changes for Study: NCT05964413
Phase III Trial to Investigate Efficacy and Safety of Vilobelimab in Ulcerative Pyoderma Gangrenosum
Latest version (submitted May 16, 2024) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 July 24, 2023 None (earliest Version on record)
2 July 28, 2023 Study Status
3 August 18, 2023 Recruitment Status, Arms and Interventions, Study Status, Outcome Measures, Contacts/Locations, Eligibility, Oversight and Study Identification
4 October 23, 2023 Contacts/Locations and Study Status
5 November 1, 2023 Study Status and Contacts/Locations
6 November 11, 2023 Contacts/Locations and Study Status
7 January 9, 2024 Contacts/Locations and Study Status
8 January 17, 2024 Contacts/Locations and Study Status
9 March 1, 2024 Study Status and Contacts/Locations
10 April 27, 2024 Contacts/Locations and Study Status
11 May 16, 2024 Study Status and Contacts/Locations
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Study NCT05964413
Submitted Date:  April 27, 2024 (v10)

Open or close this module Study Identification
Unique Protocol ID: IFX-1-P3.4
Brief Title: Phase III Trial to Investigate Efficacy and Safety of Vilobelimab in Ulcerative Pyoderma Gangrenosum
Official Title: 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
Secondary IDs:
Open or close this module Study Status
Record Verification: April 2024
Overall Status: Recruiting
Study Start: August 15, 2023
Primary Completion: February 13, 2026 [Anticipated]
Study Completion: May 15, 2026 [Anticipated]
First Submitted: June 29, 2023
First Submitted that
Met QC Criteria:
July 24, 2023
First Posted: July 27, 2023 [Actual]
Last Update Submitted that
Met QC Criteria:
April 27, 2024
Last Update Posted: April 30, 2024 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: InflaRx GmbH
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring:
Open or close this module Study Description
Brief Summary: 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
Detailed Description:
Open or close this module Conditions
Conditions: Pyoderma Gangrenosum
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation: Randomized
Enrollment: 90 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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
Open or close this module Outcome Measures
Primary Outcome Measures:
1. 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
Secondary Outcome Measures:
1. 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. 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
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

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).
Open or close this module Contacts/Locations
Central Contact Person: Dorothee Neukirchen, Dr.
Telephone: +49 89 4141897800
Email: clinicaltrials@inflarx.de
Central Contact Backup: Alex GO Loayza, Prof, MD
Telephone: +49 89 414 189 78 00
Locations: United States, Florida
Aby´s New Generation Research, Inc
[Recruiting]
Hialeah, Florida, United States, 33016
Dermatology/University of Miami Hospital
[Recruiting]
Miami, Florida, United States, 33146
University of Central Florida College of Medicine
[Recruiting]
Orlando, Florida, United States, 32827
ForCare Clinical Research
[Recruiting]
Tampa, Florida, United States, 33613
United States, Georgia
Advanced Medical Research, PC
[Recruiting]
Sandy Springs, Georgia, United States, 30328
United States, Massachusetts
Brigham and Women's Hospital
[Recruiting]
Boston, Massachusetts, United States, 02115
Brigham and Women´s Hospital
[Recruiting]
Boston, Massachusetts, United States, 02115
United States, North Carolina
University of North Carolina at Chapel Hill Department of Dermatology
[Recruiting]
Chapel Hill, North Carolina, United States, 27516
United States, Ohio
Ohio State University
[Recruiting]
Columbus, Ohio, United States, 432115
Apex Clinical Research Center
[Recruiting]
Mayfield Heights, Ohio, United States, 44124
Apex Clinical Research Center
[Recruiting]
Ohio City, Ohio, United States, 44124
United States, Oregon
Oregon Health and Science University
[Recruiting]
Portland, Oregon, United States, 97239
United States, Pennsylvania
University of Pennsylvania
[Recruiting]
Philadelphia, Pennsylvania, United States, 19194
United States, Texas
The University of Texas Health Science Center at Houston
[Recruiting]
Bellaire, Texas, United States, 77401
Australia
Veracity Clinical Research Center
[Recruiting]
Brisbane, Australia, 4102
Veracity Clinical Research Pty Ltd (ACN 163 889 361) as trustee for the MLS Trust (ABN 49 688 437 341)
[Recruiting]
Brisbane, Australia
The Alfred Hospital, Melbourne
[Recruiting]
Melbourne, Australia
Australia, New South Wales
Premier Specialists
[Recruiting]
Kogarah, New South Wales, Australia, 2217
Australia, NewSouth Wales
Premier Specialists
[Recruiting]
Kogarah, NewSouth Wales, Australia
Australia, Victoria
The Alfred Hospital, Melbourne
[Recruiting]
Melbourne, Victoria, Australia, 3004
France
Hospital Edouard Herriot
[Recruiting]
Lyon, France, 69003
Hopital Edouard Herriot
[Recruiting]
Lyon, France
CHU de Nantes - Clinique dermatologique
[Recruiting]
Nantes, France
Saint Louis Hospital
[Recruiting]
Paris, France, 75010
Saint Louis Hospital
[Recruiting]
Paris, France
CHU Toulouse - Hôpital Larrey
[Recruiting]
Toulouse, France
France, Occitanie
CHU Toulouse Hospital Larrey
[Recruiting]
Toulouse, Occitanie, France, 31000
Germany
Charite Universitätsmedizin Berlin
[Recruiting]
Berlin, Germany, 10117
Charité - Universitätsmedizin Berlin, Department of Dermatology, Venereology and Allergology, Berlin, Germany
[Recruiting]
Berlin, Germany
Berge Hautklinik Uniklinikum Erlangen
[Recruiting]
Erlangen, Germany
Universitätsklinikum Frankfurt, Klinik für Dermatologie, Venerologie und Allergologie
[Recruiting]
Frankfurt, Germany
University Hospital Leipzig AöR
[Recruiting]
Leipzig, Germany
Germany, Baden Würrtemberg
Universitätshautklinik Tübingen
[Recruiting]
Tübingen, Baden Würrtemberg, Germany, 72076
Germany, Bavaria
Berge Hautklinik
[Recruiting]
Erlangen, Bavaria, Germany, 91054
Universitätsklinikum Heidelberg
[Recruiting]
Heidelberg, Bavaria, Germany, 69120
Klinik und Poliklinik für Dermatologie und Allergologie
[Recruiting]
München, Bavaria, Germany, 80337
University Hospital Würzburg, Department of Dermatology
[Recruiting]
Würzburg, Bavaria, Germany, 97080
Germany, Hessen
Universitätsklinikum Frankfurt, Klinik für Dermatologie
[Recruiting]
Frankfurt, Hessen, Germany, 60590
Germany, Nordrhein-Westfalen
University of Essen, Germany
[Recruiting]
Essen, Nordrhein-Westfalen, Germany
Germany, Nordrhein-Westfalia
Catholic Clinic Bochum, Department of Dermatology
[Recruiting]
Bochum, Nordrhein-Westfalia, Germany, 44791
Hungary
Department of Dermatology, Venerology and Oncodermatology, University of Pécs
[Recruiting]
Pécs, Hungary
Department of Dermatology and Allergology, University of Szeged
[Recruiting]
Szeged, Hungary
Hungary, Baranya
Department of Dermatology and Venerology and Oncodermatology, University of Pecs
[Recruiting]
Pécs, Baranya, Hungary, 7632
Hungary, Csongrad-Csanad
Department of Dermatology and Allergology, University of Szeged
[Recruiting]
Szeged, Csongrad-Csanad, Hungary, 6720
Hungary, Hadju-Bihar
Department of Dermatology, University of Debrecen
[Recruiting]
Debrecen, Hadju-Bihar, Hungary, 4032
Italy
Fondazione IRCCS Ca´ Granda Ospedale Maggiore Policlinico SC Dermatologia
[Recruiting]
Milan, Italy, 20122
University of Pisa, Santa Chiara Hospital
[Recruiting]
Pisa, Italy, 56124
PIsa University of Pisa Santa Chiara Hospital
[Recruiting]
Pisa, Italy
AOU Città della salute e della scienza
[Recruiting]
Turin, Italy
Poland
Państwowy Instytut Medyczny CSK MSWiA
[Recruiting]
Warsaw, Poland
City Clinic Przychodnia Lekarsko-Psychologiczna ul. Sliczna 13, Wroclaw, Poland
[Recruiting]
Wrocław, Poland
Wojewódzki Specjalistyczny Szpital im. Dr Wł. Biegańskiego w Łodzi; Klinika Dermatologii, Dermatologii Dziecięcej i Onkologicznej Uniwersytetu Medycznego
[Recruiting]
Łódź, Poland
Poland, Lower Silesia
City Clinic Lekarsko Psychologiczna ul. Sliczna 13, Wroclaw
[Recruiting]
Wrocław, Lower Silesia, Poland, 50-566
Poland, Mazowsze
Paistowny Instytut Mediczny CSK
[Recruiting]
Warsaw, Mazowsze, Poland, 02-507
Poland, Warminsko
Clinic of Dermatology, Transmitted Diseases and Clinical Immunology
[Recruiting]
Olsztyn, Warminsko, Poland, 10229
Spain
Complejo Asistencial Universitario de Salamanca
[Recruiting]
Salamanca, Spain, 37007
Switzerland
University Hospital Basel
[Recruiting]
Basel, Switzerland, 4055
University Hospital Basel Department of Dermatology at Universitäre Altersmedizin FELIX PLATTER
[Recruiting]
Basel, Switzerland
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Citations:
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Available IPD/Information:

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