Exploratory Study of IFX-1 in Subjects With Pyoderma Gangrenosum

• Status: Recruiting
• Trial end date: 2022-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether IFX-1 is safe and effective in the treatment of pyoderma gangrenosum.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: InflaRx GmbH
• Collaborator: Innovaderm Research Inc.
• Treatments: Vilobelimab

Criteria

Inclusion Criteria:

• Diagnosis of an ulcerative form of pyoderma gangrenosum confirmed by the investigator

In addition, the subject must fulfill at least 3 of the following 6 criteria at screening:

History of

• Pathergy (ulcer occurring at the sites of trauma)

• Personal history of inflammatory bowel disease or inflammatory arthritis

• History of papule, pustule or vesicle that rapidly ulcerated

Clinical examination (or photographic evidence) of

• Peripheral erythema, undermining border, and tenderness at site of ulceration

• Multiple ulcerations (at least 1 occurring on the lower leg)

• Cribriform or "wrinkled paper" scar(s) at sites of healed ulcers

Subject has a minimum of 1 evaluable ulcer (≥2 cm2) on the lower extremity at screening

Exclusion Criteria:

• Pyoderma gangrenosum target ulcer for more than 3 years before screening

• Surgical wound debridement within the previous 2 weeks before screening

• Use of intravenous antibacterials, antivirals, anti-fungals, or anti-parasitic agents within 30 days before screening

• Any drug treatment for pyoderma gangrenosum including corticosteroids (>10 mg), intralesional steroids, cyclosporine A, biologicals and immunosuppressives (with the exception of antibiotics for wound superinfection) used within a time of 5 half-lives of the drug before screening