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

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).