Phase III Trial to Investigate Efficacy and Safety of Vilobelimab in Ulcerative Pyoderma Gangrenosum
- Registration Number
- NCT05964413
- Lead Sponsor
- InflaRx GmbH
- 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
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 90
-
18 years or older at the time of signing the informed consent.
-
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.
-
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
- Patients with target ulcers exceeding 80 cm 2 .
- Patients with target ulcer in transplanted skin.
- 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).
- Patient with previous exposure to vilobelimab (IFX-1) prior to baseline (i.e., start of treatment with IMP).
- Patient receives/has received a vaccine within 2 weeks prior to baseline (i.e., start of treatment with IMP).
- 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).
- Patients received any systemic medical treatment for PG within 4 weeks prior to baseline
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description vilobelimab vilobelimab Patients will be treated with vilobelimab IV, Q2W for 26 weeks Placebo Placebo Patients will receive placebo IV in the same schedule as patients in Arm 1
- Primary Outcome Measures
Name Time Method Efficacy of treatment with vilobelimab compared to placebo Week 1 to Week 26 Efficacy of Vilobelimab compared to placebo - complete closure of the ulcer
- Secondary Outcome Measures
Name Time Method Efficacy of treatment with vilobelimab compared to placebo 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
Pain reduction 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
Trial Locations
- Locations (50)
Liverpool Hospital
🇦🇺Sydney, Australia
Hospital Ramon y Cajal
🇪🇸Salamanca, Spain
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
Hôpitaux Universitaires de Bruxelles
🇧🇪Anderlecht, Belgium
Cliniques Universitaires Saint-Luc
🇧🇪Brussel, 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, Hessen, Germany
University of Essen, Germany
🇩🇪Essen, Nordrhein-Westfalen, Germany
Catholic Clinic Bochum, Department of Dermatology
🇩🇪Bochum, Nordrhein-Westfalia, 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
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
🇵🇱Wrocław, Poland
Wojewódzki Specjalistyczny Szpital im. Dr Wł. Biegańskiego w Łodzi; Klinika Dermatologii, Dermatologii Dziecięcej i Onkologicznej Uniwersytetu Medycznego
🇵🇱Łódź, Poland
Complejo Asistencial Universitario de Salamanca
🇪🇸Salamanca, Spain
University Hospital Basel Department of Dermatology at Universitäre Altersmedizin FELIX PLATTER
🇨🇭Basel, Switzerland