Clinical trial NCT05964413: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Pyoderma Gangrenosum
Lead sponsor: InflaRx GmbH
Sponsor class: INDUSTRY
First posted: 2023-07-27
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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).

Primary outcomes:
measure: Efficacy of treatment with vilobelimab compared to placebo
timeFrame: Week 1 to Week 26
Secondary outcomes:
measure: Efficacy of treatment with vilobelimab compared to placebo
timeFrame: 2 weeks between study visits
measure: Pain reduction
timeFrame: Week 10 through study completion
Other outcomes:
Locations:
city: Hialeah
country: United States
facility: Aby´s New Generation Research, Inc
state: Florida
city: Miami
country: United States
facility: Dermatology/University of Miami Hospital
state: Florida
city: Orlando
country: United States
facility: University of Central Florida College of Medicine
state: Florida
city: Tampa
country: United States
facility: ForCare Clinical Research
state: Florida
city: Sandy Springs
country: United States
facility: Advanced Medical Research, PC
state: Georgia
city: Boston
country: United States
facility: Brigham and Women´s Hospital
state: Massachusetts
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill Department of Dermatology
state: North Carolina
city: Columbus
country: United States
facility: Ohio State University Wexner Medical Cente OSU Dermatology West
state: Ohio
city: Mayfield Heights
country: United States
facility: Apex Clinical Research Center
state: Ohio
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Bellaire
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
city: Kogarah
country: Australia
facility: Premier Specialists
state: NewSouth Wales
city: Melbourne
country: Australia
facility: The Alfred Hospital, Melbourne
state: Victoria
city: Brisbane
country: Australia
facility: Veracity Clinical Research Pty Ltd as trustee for the MLS Trust
city: Sydney
country: Australia
facility: Liverpool Hospital
city: Anderlecht
country: Belgium
facility: Hôpitaux Universitaires de Bruxelles
city: Brussel
country: Belgium
facility: Cliniques Universitaires Saint-Luc
city: Toulouse
country: France
facility: CHU Toulouse Hospital Larrey
state: Occitanie
city: Lyon
country: France
facility: Hospital Edouard Herriot
city: Nantes
country: France
facility: CHU de Nantes - Clinique dermatologique
city: Paris
country: France
facility: Saint Louis Hospital
city: Tübingen
country: Germany
facility: Universitätshautklinik Tübingen
state: Baden Würrtemberg
city: Erlangen
country: Germany
facility: Berge Hautklinik
state: Bavaria
city: Heidelberg
country: Germany
facility: Universitätsklinikum Heidelberg
state: Bavaria
city: München
country: Germany
facility: Klinik und Poliklinik für Dermatologie und Allergologie
state: Bavaria
city: Würzburg
country: Germany
facility: University Hospital Würzburg, Department of Dermatology
state: Bavaria
city: Frankfurt
country: Germany
facility: Universitätsklinikum Frankfurt, Klinik für Dermatologie
state: Hessen
city: Essen
country: Germany
facility: University of Essen, Germany
state: Nordrhein-Westfalen
city: Bochum
country: Germany
facility: Catholic Clinic Bochum, Department of Dermatology
state: Nordrhein-Westfalia
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin, Department of Dermatology, Venereology and Allergology, Berlin, Germany
city: Düsseldorf
country: Germany
facility: University clinic Duesseldorf Department of Dermatology Heinrich-Heine-University Duesseldorf
city: Halle
country: Germany
facility: Universitätsklinik für Dermatologie und Venerologie der MLU Halle
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg-Eppendorf, Institut für Versorgungsforschung in der Dermatologie und bei Pflegeberufen (IVDP)
city: Leipzig
country: Germany
facility: University Hospital Leipzig AöR
city: Szeged
country: Hungary
facility: Department of Dermatology and Allergology, University of Szeged
state: Csongrad-Csanad
city: Debrecen
country: Hungary
facility: Department of Dermatology, University of Debrecen
state: Hadju-Bihar
city: Pécs
country: Hungary
facility: Department of Dermatology, Venerology and Oncodermatology, University of Pécs
city: Bologna
country: Italy
facility: IRCCS Policlinico di Sant'Orsola Alma Mater Studiorum - University of Bologna
city: Milan
country: Italy
facility: Fondazione IRCCS Ca´ Granda Ospedale Maggiore Policlinico SC Dermatologia
city: Pisa
country: Italy
facility: Ospedale Santa Chiara
city: Turin
country: Italy
facility: AOU Città della salute e della scienza
city: Lublin
country: Poland
facility: Department and Clinics of Dermatology, Venereology and Paediatric Dermatology, Medical University of Lublin,
city: Olsztyn
country: Poland
facility: Klinika Dermatologii, Chorób Przenoszonych Drogą Płciową i Immunologii Klininczej, Miejski Szpital Zespolony w Olsztynie Clinic of Dermatology,
city: Warsaw
country: Poland
facility: Państwowy Instytut Medyczny CSK MSWiA
city: Wrocław
country: Poland
facility: City Clinic Przychodnia Lekarsko-Psychologiczna ul. Sliczna 13, Wroclaw, Poland
city: Łódź
country: Poland
facility: Wojewódzki Specjalistyczny Szpital im. Dr Wł. Biegańskiego w Łodzi; Klinika Dermatologii, Dermatologii Dziecięcej i Onkologicznej Uniwersytetu Medycznego
city: Madrid
country: Spain
facility: Hospital Ramón y Cajal
city: Salamanca
country: Spain
facility: Complejo Asistencial Universitario de Salamanca
city: Basel
country: Switzerland
facility: University Hospital Basel Department of Dermatology at Universitäre Altersmedizin FELIX PLATTER
Study officials:
affiliation: university
name: Alex GO Loayza, Prof, MD
role: PRINCIPAL_INVESTIGATOR
References: