Exploratory Study of IFX-1 in Patients With Pyoderma Gangrenosum (NCT03971643) | Clinical Trial Compass
CompletedPhase 2
Exploratory Study of IFX-1 in Patients With Pyoderma Gangrenosum
United States19 participantsStarted 2019-05-16
Plain-language summary
The purpose of this study is to determine whether vilobelimab (development name: IFX-1) is safe and effective in the treatment of pyoderma gangrenosum.
Who can participate
Age range18 Years
SexALL
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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
What they're measuring
1
Treatment-emergent Adverse Events (TEAEs), Related TEAEs, Serious TEAEs, and Adverse Events of Special Interest (AESIs)
Timeframe: From treatment start until end of study (including observational visits), an average of 249 days