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

Pyoderma Gangrenosum Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05964413
• Other study ID #: IFX-1-P3.4
• Status: Recruiting
• Phase: Phase 3
• Start date: August 15, 2023
• Est. completion date: May 15, 2026

Study information

• Verified date: April 2024
• Source: InflaRx GmbH
• Contact: Dorothee Neukirchen, Dr.
• Phone: +49 89 4141897800
• Email: clinicaltrials[@]inflarx.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: May 15, 2026
• Est. primary completion date: February 13, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Pyoderma
• Pyoderma Gangrenosum

Intervention

Drug:
• vilobelimab
vilobelimab infusion
• Placebo
Placebo Infusion

Locations

Country	Name	City	State
Australia	Veracity Clinical Research Center	Brisbane
Australia	Veracity Clinical Research Pty Ltd (ACN 163 889 361) as trustee for the MLS Trust (ABN 49 688 437 341)	Brisbane
Australia	Premier Specialists	Kogarah	New South Wales
Australia	Premier Specialists	Kogarah	NewSouth Wales
Australia	The Alfred Hospital, Melbourne	Melbourne	Victoria
Australia	The Alfred Hospital, Melbourne	Melbourne
France	Hopital Edouard Herriot	Lyon
France	Hospital Edouard Herriot	Lyon
France	CHU de Nantes - Clinique dermatologique	Nantes
France	Saint Louis Hospital	Paris
France	Saint Louis Hospital	Paris
France	CHU Toulouse - Hôpital Larrey	Toulouse
France	CHU Toulouse Hospital Larrey	Toulouse	Occitanie
Germany	Charité - Universitätsmedizin Berlin, Department of Dermatology, Venereology and Allergology, Berlin, Germany	Berlin
Germany	Charite Universitätsmedizin Berlin	Berlin
Germany	Catholic Clinic Bochum, Department of Dermatology	Bochum	Nordrhein-Westfalia
Germany	Berge Hautklinik	Erlangen	Bavaria
Germany	Berge Hautklinik Uniklinikum Erlangen	Erlangen
Germany	University of Essen, Germany	Essen	Nordrhein-Westfalen
Germany	Universitätsklinikum Frankfurt, Klinik für Dermatologie	Frankfurt	Hessen
Germany	Universitätsklinikum Frankfurt, Klinik für Dermatologie, Venerologie und Allergologie	Frankfurt
Germany	Universitätsklinikum Heidelberg	Heidelberg	Bavaria
Germany	University Hospital Leipzig AöR	Leipzig
Germany	Klinik und Poliklinik für Dermatologie und Allergologie	München	Bavaria
Germany	Universitätshautklinik Tübingen	Tübingen	Baden Würrtemberg
Germany	University Hospital Würzburg, Department of Dermatology	Würzburg	Bavaria
Hungary	Department of Dermatology, University of Debrecen	Debrecen	Hadju-Bihar
Hungary	Department of Dermatology and Venerology and Oncodermatology, University of Pecs	Pécs	Baranya
Hungary	Department of Dermatology, Venerology and Oncodermatology, University of Pécs	Pécs
Hungary	Department of Dermatology and Allergology, University of Szeged	Szeged
Hungary	Department of Dermatology and Allergology, University of Szeged	Szeged	Csongrad-Csanad
Italy	Fondazione IRCCS Ca´ Granda Ospedale Maggiore Policlinico SC Dermatologia	Milan
Italy	PIsa University of Pisa Santa Chiara Hospital	Pisa
Italy	University of Pisa, Santa Chiara Hospital	Pisa
Italy	AOU Città della salute e della scienza	Turin
Poland	Wojewódzki Specjalistyczny Szpital im. Dr Wl. Bieganskiego w Lodzi; Klinika Dermatologii, Dermatologii Dzieciecej i Onkologicznej Uniwersytetu Medycznego	Lódz
Poland	Clinic of Dermatology, Transmitted Diseases and Clinical Immunology	Olsztyn	Warminsko
Poland	Paistowny Instytut Mediczny CSK	Warsaw	Mazowsze
Poland	Panstwowy Instytut Medyczny CSK MSWiA	Warsaw
Poland	City Clinic Lekarsko Psychologiczna ul. Sliczna 13, Wroclaw	Wroclaw	Lower Silesia
Poland	City Clinic Przychodnia Lekarsko-Psychologiczna ul. Sliczna 13, Wroclaw, Poland	Wroclaw
Spain	Complejo Asistencial Universitario de Salamanca	Salamanca
Switzerland	University Hospital Basel	Basel
Switzerland	University Hospital Basel Department of Dermatology at Universitäre Altersmedizin FELIX PLATTER	Basel
United States	The University of Texas Health Science Center at Houston	Bellaire	Texas
United States	Brigham and Women's Hospital	Boston	Massachusetts
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	Columbus	Ohio
United States	Aby´s New Generation Research, Inc	Hialeah	Florida
United States	Apex Clinical Research Center	Mayfield Heights	Ohio
United States	Dermatology/University of Miami Hospital	Miami	Florida
United States	Apex Clinical Research Center	Ohio City	Ohio
United States	University of Central Florida College of Medicine	Orlando	Florida
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Oregon Health and Science University	Portland	Oregon
United States	Advanced Medical Research, PC	Sandy Springs	Georgia
United States	ForCare Clinical Research	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
InflaRx GmbH

Countries where clinical trial is conducted

United States,  Australia,  France,  Germany,  Hungary,  Italy,  Poland,  Spain,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Efficacy of treatment with vilobelimab compared to placebo	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	2 weeks between study visits
Secondary	Pain reduction	Proportion of patients achieving a pain reduction related to the target ulcer of at least 3 points compared to baseline	Week 10 through study completion