Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial 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
Funding Agency/Sponsor
Industry
Disease
Skin Lesions
Enrollment Eligibility
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