Status:
TERMINATED
Phase III Trial to Investigate Efficacy and Safety of Vilobelimab in Ulcerative Pyoderma Gangrenosum
Lead Sponsor:
InflaRx GmbH
Conditions:
Pyoderma Gangrenosum
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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
Inclusion
- Main
- 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
- Main
Exclusion
- 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).
Key Trial Info
Start Date :
November 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 11 2025
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT05964413
Start Date
November 1 2023
End Date
July 11 2025
Last Update
November 4 2025
Active Locations (50)
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1
Aby´s New Generation Research, Inc
Hialeah, Florida, United States, 33016
2
Dermatology/University of Miami Hospital
Miami, Florida, United States, 33146
3
University of Central Florida College of Medicine
Orlando, Florida, United States, 32827
4
ForCare Clinical Research
Tampa, Florida, United States, 33613