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
Status: Terminated
Location: See all (50) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
United States
Florida
Aby´s New Generation Research, Inc
Hialeah
Dermatology/University of Miami Hospital
Miami
University of Central Florida College of Medicine
Orlando
ForCare Clinical Research
Tampa
Georgia
Advanced Medical Research, PC
Sandy Springs
Massachusetts
Brigham and Women´s Hospital
Boston
North Carolina
University of North Carolina at Chapel Hill Department of Dermatology
Chapel Hill
Ohio
Ohio State University Wexner Medical Cente OSU Dermatology West
Columbus
Apex Clinical Research Center
Mayfield Heights
Oregon
Oregon Health and Science University
Portland
Pennsylvania
University of Pennsylvania
Philadelphia
Texas
The University of Texas Health Science Center at Houston
Bellaire
Other Locations
Australia
Veracity Clinical Research Pty Ltd as trustee for the MLS Trust
Brisbane
Premier Specialists
Kogarah
The Alfred Hospital, Melbourne
Melbourne
Liverpool Hospital
Sydney
Belgium
Hôpitaux Universitaires de Bruxelles
Anderlecht
Cliniques Universitaires Saint-Luc
Brussels
France
Hospital Edouard Herriot
Lyon
CHU de Nantes - Clinique dermatologique
Nantes
Saint Louis Hospital
Paris
CHU Toulouse Hospital Larrey
Toulouse
Germany
Charité - Universitätsmedizin Berlin, Department of Dermatology, Venereology and Allergology, Berlin, Germany
Berlin
Catholic Clinic Bochum, Department of Dermatology
Bochum
University clinic Duesseldorf Department of Dermatology Heinrich-Heine-University Duesseldorf
Düsseldorf
Berge Hautklinik
Erlangen
University of Essen, Germany
Essen
Universitätsklinikum Frankfurt, Klinik für Dermatologie
Frankfurt Am Main
Universitätsklinik für Dermatologie und Venerologie der MLU Halle
Halle
Universitätsklinikum Hamburg-Eppendorf, Institut für Versorgungsforschung in der Dermatologie und bei Pflegeberufen (IVDP)
Hamburg
Universitätsklinikum Heidelberg
Heidelberg
University Hospital Leipzig AöR
Leipzig
Klinik und Poliklinik für Dermatologie und Allergologie
München
Universitätshautklinik Tübingen
Tübingen
University Hospital Würzburg, Department of Dermatology
Würzburg
Hungary
Department of Dermatology, University of Debrecen
Debrecen
Department of Dermatology, Venerology and Oncodermatology, University of Pécs
Pécs
Department of Dermatology and Allergology, University of Szeged
Szeged
Italy
IRCCS Policlinico di Sant'Orsola Alma Mater Studiorum - University of Bologna
Bologna
Fondazione IRCCS Ca´ Granda Ospedale Maggiore Policlinico SC Dermatologia
Milan
Ospedale Santa Chiara
Pisa
AOU Città della salute e della scienza
Turin
Poland
Wojewódzki Specjalistyczny Szpital im. Dr Wł. Biegańskiego w Łodzi; Klinika Dermatologii, Dermatologii Dziecięcej i Onkologicznej Uniwersytetu Medycznego
Lodz
Department and Clinics of Dermatology, Venereology and Paediatric Dermatology, Medical University of Lublin,
Lublin
Klinika Dermatologii, Chorób Przenoszonych Drogą Płciową i Immunologii Klininczej, Miejski Szpital Zespolony w Olsztynie Clinic of Dermatology,
Olsztyn
Państwowy Instytut Medyczny CSK MSWiA
Warsaw
City Clinic Przychodnia Lekarsko-Psychologiczna ul. Sliczna 13, Wroclaw, Poland
Wroclaw
Spain
Hospital Ramón y Cajal
Madrid
Complejo Asistencial Universitario de Salamanca
Salamanca
Switzerland
University Hospital Basel Department of Dermatology at Universitäre Altersmedizin FELIX PLATTER
Basel
Time Frame
Start Date: 2023-11-01
Completion Date: 2025-07-11
Participants
Target number of participants: 54
Treatments
Experimental: vilobelimab
Patients will be treated with vilobelimab IV, Q2W for 26 weeks
Placebo_comparator: Placebo
Patients will receive placebo IV in the same schedule as patients in Arm 1
Related Therapeutic Areas
Sponsors
Leads: InflaRx GmbH