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

Launched by INFLARX GMBH · Jul 24, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called vilobelimab for people with a condition known as ulcerative pyoderma gangrenosum, which causes painful ulcers on the skin. The trial is in its final phase (Phase III) and aims to see how effective and safe vilobelimab is compared to a placebo, which is a treatment that looks like the real drug but doesn’t contain any active medication. The trial is currently recruiting participants aged 18 and older who have been diagnosed with ulcerative pyoderma gangrenosum and have at least one ulcer that meets specific size criteria.

To join the study, participants must not have certain medical conditions or recent treatments that could affect their participation. Those who qualify will receive either vilobelimab or the placebo and will be monitored closely throughout the trial. This is a significant opportunity for patients with ulcerative pyoderma gangrenosum, as it may lead to new, effective treatment options for this challenging condition.

Gender

ALL

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).