Phase III Trial to Investigate Efficacy and Safety of Vilobelimab in Ulcerative Pyoderma Gangrenosum

NCT05964413 | Terminated Phase 3 FDA Drug

• 1 other identifier: IFX-1-P3.4
• Study Type: interventional
• Target: 54
• Locations: 10 countries
• Sites: 50

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

Conditions

Pyoderma Gangrenosum

Outcome Measures

Primary Outcomes (1)

• Efficacy of treatment with vilobelimab compared to placebo

  Efficacy of Vilobelimab compared to placebo - complete closure of the ulcer

  Week 1 to Week 26

Secondary Outcomes (2)

• Efficacy of treatment with vilobelimab compared to placebo

  2 weeks between study visits

• Pain reduction

  Week 10 through study completion

Study Arms (2)

vilobelimab

EXPERIMENTAL

Patients will be treated with vilobelimab IV, Q2W for 26 weeks

Drug: vilobelimab

Placebo

PLACEBO COMPARATOR

Patients will receive placebo IV in the same schedule as patients in Arm 1

Drug: Placebo

Interventions

vilobelimab DRUG

vilobelimab infusion

vilobelimab

Placebo DRUG

Placebo Infusion

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• InflaRx GmbH: lead

Study Sites (50)

Aby´s New Generation Research, Inc

Hialeah, Florida, 33016, United States

Location

Dermatology/University of Miami Hospital

Miami, Florida, 33146, United States

Location

University of Central Florida College of Medicine

Orlando, Florida, 32827, United States

Location

ForCare Clinical Research

Tampa, Florida, 33613, United States

Location

Advanced Medical Research, PC

Sandy Springs, Georgia, 30328, United States

Location

Brigham and Women´s Hospital

Boston, Massachusetts, 02115, United States

Location

University of North Carolina at Chapel Hill Department of Dermatology

Chapel Hill, North Carolina, 27516, United States

Location

Ohio State University Wexner Medical Cente OSU Dermatology West

Columbus, Ohio, 43215, United States

Location

Apex Clinical Research Center

Mayfield Heights, Ohio, 44124, United States

Location

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19194, United States

Location

The University of Texas Health Science Center at Houston

Bellaire, Texas, 77401, United States

Location

Premier Specialists

Kogarah, NewSouth Wales, Australia

Location

The Alfred Hospital, Melbourne

Melbourne, Victoria, 3004, Australia

Location

Veracity Clinical Research Pty Ltd as trustee for the MLS Trust

Brisbane, Australia

Location

Liverpool Hospital

Sydney, Australia

Location

Hôpitaux Universitaires de Bruxelles

Anderlecht, Belgium

Location

Cliniques Universitaires Saint-Luc

Brussels, Belgium

Location

CHU Toulouse Hospital Larrey

Toulouse, Occitanie, 31000, France

Location

Hospital Edouard Herriot

Lyon, 69003, France

Location

CHU de Nantes - Clinique dermatologique

Nantes, 44093, France

Location

Saint Louis Hospital

Paris, 75010, France

Location

Universitätshautklinik Tübingen

Tübingen, Baden Würrtemberg, 72076, Germany

Location

Berge Hautklinik

Erlangen, Bavaria, 91054, Germany

Location

Universitätsklinikum Heidelberg

Heidelberg, Bavaria, 69120, Germany

Location

Klinik und Poliklinik für Dermatologie und Allergologie

München, Bavaria, 80337, Germany

Location

University Hospital Würzburg, Department of Dermatology

Würzburg, Bavaria, 97080, Germany

Location

Universitätsklinikum Frankfurt, Klinik für Dermatologie

Frankfurt am Main, Hesse, 60590, Germany

Location

Catholic Clinic Bochum, Department of Dermatology

Bochum, Nordrhein-Westfalia, 44791, Germany

Location

University of Essen, Germany

Essen, North Rhine-Westphalia, Germany

Location

Charité - Universitätsmedizin Berlin, Department of Dermatology, Venereology and Allergology, Berlin, Germany

Berlin, Germany

Location

University clinic Duesseldorf Department of Dermatology Heinrich-Heine-University Duesseldorf

Düsseldorf, Germany

Location

Universitätsklinik für Dermatologie und Venerologie der MLU Halle

Halle, Germany

Location

Universitätsklinikum Hamburg-Eppendorf, Institut für Versorgungsforschung in der Dermatologie und bei Pflegeberufen (IVDP)

Hamburg, Germany

Location

University Hospital Leipzig AöR

Leipzig, Germany

Location

Department of Dermatology and Allergology, University of Szeged

Szeged, Csongrad-Csanad, 6720, Hungary

Location

Department of Dermatology, University of Debrecen

Debrecen, Hadju-Bihar, 4032, Hungary

Location

Department of Dermatology, Venerology and Oncodermatology, University of Pécs

Pécs, Hungary

Location

IRCCS Policlinico di Sant'Orsola Alma Mater Studiorum - University of Bologna

Bologna, Italy

Location

Fondazione IRCCS Ca´ Granda Ospedale Maggiore Policlinico SC Dermatologia

Milan, 20122, Italy

Location

Ospedale Santa Chiara

Pisa, 56126, Italy

Location

AOU Città della salute e della scienza

Turin, Italy

Location

Wojewódzki Specjalistyczny Szpital im. Dr Wł. Biegańskiego w Łodzi; Klinika Dermatologii, Dermatologii Dziecięcej i Onkologicznej Uniwersytetu Medycznego

Lodz, Poland

Location

Department and Clinics of Dermatology, Venereology and Paediatric Dermatology, Medical University of Lublin,

Lublin, Poland

Location

Klinika Dermatologii, Chorób Przenoszonych Drogą Płciową i Immunologii Klininczej, Miejski Szpital Zespolony w Olsztynie Clinic of Dermatology,

Olsztyn, Poland

Location

Państwowy Instytut Medyczny CSK MSWiA

Warsaw, Poland

Location

City Clinic Przychodnia Lekarsko-Psychologiczna ul. Sliczna 13, Wroclaw, Poland

Wroclaw, Poland

Location

Hospital Ramón y Cajal

Madrid, 28034, Spain

Location

Complejo Asistencial Universitario de Salamanca

Salamanca, Spain

Location

University Hospital Basel Department of Dermatology at Universitäre Altersmedizin FELIX PLATTER

Basel, Switzerland

Location

MeSH Terms

Conditions

Pyoderma Gangrenosum

Interventions

vilobelimab

Condition Hierarchy (Ancestors)

Pyoderma; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Vascular; Skin Ulcer

Study Officials

• Alex GO Loayza, Prof, MD

  university

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2023
• First Posted: July 27, 2023
• Study Start: November 1, 2023
• Primary Completion: July 11, 2025
• Study Completion: July 11, 2025
• Last Updated: November 4, 2025

Record last verified: 2025-11

Locations

HU (3); US (12); BE (2); IT (4); PL (5); ES (2); DE (13); AU (4); CH (1); FR (4)