Phase III Trial to Investigate Efficacy and Safety of Vilobelimab in Ulcerative Pyoderma Gangrenosum
NCT ID: NCT05964413
Last Updated: 2025-11-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
54 participants
INTERVENTIONAL
2023-11-01
2025-07-11
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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vilobelimab
Patients will be treated with vilobelimab IV, Q2W for 26 weeks
vilobelimab
vilobelimab infusion
Placebo
Patients will receive placebo IV in the same schedule as patients in Arm 1
Placebo
Placebo Infusion
Interventions
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vilobelimab
vilobelimab infusion
Placebo
Placebo Infusion
Eligibility Criteria
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Inclusion Criteria
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
Exclusion Criteria
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).
18 Years
ALL
No
Sponsors
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InflaRx GmbH
INDUSTRY
Responsible Party
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Principal Investigators
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Alex GO Loayza, Prof, MD
Role: PRINCIPAL_INVESTIGATOR
university
Locations
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Aby´s New Generation Research, Inc
Hialeah, Florida, United States
Dermatology/University of Miami Hospital
Miami, Florida, United States
University of Central Florida College of Medicine
Orlando, Florida, United States
ForCare Clinical Research
Tampa, Florida, United States
Advanced Medical Research, PC
Sandy Springs, Georgia, United States
Brigham and Women´s Hospital
Boston, Massachusetts, United States
University of North Carolina at Chapel Hill Department of Dermatology
Chapel Hill, North Carolina, United States
Ohio State University Wexner Medical Cente OSU Dermatology West
Columbus, Ohio, United States
Apex Clinical Research Center
Mayfield Heights, Ohio, United States
Oregon Health and Science University
Portland, Oregon, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
The University of Texas Health Science Center at Houston
Bellaire, Texas, United States
Premier Specialists
Kogarah, NewSouth Wales, Australia
The Alfred Hospital, Melbourne
Melbourne, Victoria, Australia
Veracity Clinical Research Pty Ltd as trustee for the MLS Trust
Brisbane, , Australia
Liverpool Hospital
Sydney, , Australia
Hôpitaux Universitaires de Bruxelles
Anderlecht, , Belgium
Cliniques Universitaires Saint-Luc
Brussels, , Belgium
CHU Toulouse Hospital Larrey
Toulouse, Occitanie, France
Hospital Edouard Herriot
Lyon, , France
CHU de Nantes - Clinique dermatologique
Nantes, , France
Saint Louis Hospital
Paris, , France
Universitätshautklinik Tübingen
Tübingen, Baden Würrtemberg, Germany
Berge Hautklinik
Erlangen, Bavaria, Germany
Universitätsklinikum Heidelberg
Heidelberg, Bavaria, Germany
Klinik und Poliklinik für Dermatologie und Allergologie
München, Bavaria, Germany
University Hospital Würzburg, Department of Dermatology
Würzburg, Bavaria, Germany
Universitätsklinikum Frankfurt, Klinik für Dermatologie
Frankfurt am Main, Hesse, Germany
Catholic Clinic Bochum, Department of Dermatology
Bochum, Nordrhein-Westfalia, Germany
University of Essen, Germany
Essen, North Rhine-Westphalia, Germany
Charité - Universitätsmedizin Berlin, Department of Dermatology, Venereology and Allergology, Berlin, Germany
Berlin, , Germany
University clinic Duesseldorf Department of Dermatology Heinrich-Heine-University Duesseldorf
Düsseldorf, , Germany
Universitätsklinik für Dermatologie und Venerologie der MLU Halle
Halle, , Germany
Universitätsklinikum Hamburg-Eppendorf, Institut für Versorgungsforschung in der Dermatologie und bei Pflegeberufen (IVDP)
Hamburg, , Germany
University Hospital Leipzig AöR
Leipzig, , Germany
Department of Dermatology and Allergology, University of Szeged
Szeged, Csongrad-Csanad, Hungary
Department of Dermatology, University of Debrecen
Debrecen, Hadju-Bihar, Hungary
Department of Dermatology, Venerology and Oncodermatology, University of Pécs
Pécs, , Hungary
IRCCS Policlinico di Sant'Orsola Alma Mater Studiorum - University of Bologna
Bologna, , Italy
Fondazione IRCCS Ca´ Granda Ospedale Maggiore Policlinico SC Dermatologia
Milan, , Italy
Ospedale Santa Chiara
Pisa, , Italy
AOU Città della salute e della scienza
Turin, , Italy
Wojewódzki Specjalistyczny Szpital im. Dr Wł. Biegańskiego w Łodzi; Klinika Dermatologii, Dermatologii Dziecięcej i Onkologicznej Uniwersytetu Medycznego
Lodz, , Poland
Department and Clinics of Dermatology, Venereology and Paediatric Dermatology, Medical University of Lublin,
Lublin, , Poland
Klinika Dermatologii, Chorób Przenoszonych Drogą Płciową i Immunologii Klininczej, Miejski Szpital Zespolony w Olsztynie Clinic of Dermatology,
Olsztyn, , Poland
Państwowy Instytut Medyczny CSK MSWiA
Warsaw, , Poland
City Clinic Przychodnia Lekarsko-Psychologiczna ul. Sliczna 13, Wroclaw, Poland
Wroclaw, , Poland
Hospital Ramón y Cajal
Madrid, , Spain
Complejo Asistencial Universitario de Salamanca
Salamanca, , Spain
University Hospital Basel Department of Dermatology at Universitäre Altersmedizin FELIX PLATTER
Basel, , Switzerland
Countries
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Other Identifiers
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IFX-1-P3.4
Identifier Type: -
Identifier Source: org_study_id
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