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TERMINATEDPHASE3

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

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

NCT05964413•InflaRx GmbH

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

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).

Locations (50)

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

Key Dates

Start Date

November 1, 2023

Primary Completion Date

July 11, 2025

Completion Date

July 11, 2025

Last Updated

November 4, 2025

Enrollment

ACTUAL participants

Conditions

Pyoderma Gangrenosum

Interventions

vilobelimab

DRUG

Placebo

DRUG

A Study to Evaluate SHR-1139 Injection in Patients With Pyoderma Gangrenosum

NCT07444684

Pyoderma Gangrenosum

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COMPLETEDPHASE2

Baricitinib in the Treatment of Adults With Pyoderma Gangrenosum (PG)

NCT04901325

Pyoderma GangrenosumSkin Diseases+3 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 4, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Study to Evaluate SHR-1139 Injection in Patients With Pyoderma Gangrenosum

Baricitinib in the Treatment of Adults With Pyoderma Gangrenosum (PG)

JAK-STAT Signaling Pathway in Pyoderma Gangrenosum

Secukinumab for the Inflammatory Phase of Pyoderma Gangrenosum