Exploratory Study of IFX-1 in Patients With Pyoderma Gangrenosum
Completed · Phase 2
Conditions studied: Pyoderma Gangrenosum
In brief
The purpose of this study is to determine whether vilobelimab (development name: IFX-1) is safe and effective in the treatment of pyoderma gangrenosum.
Key facts
- Study ID
- NCT03971643
- Run by
- InflaRx GmbH
- People needed
- 19
- Starts
- 2019-05-16
- Expected to finish
- 2022-01-03
- Last updated by the study team
- 2023-09-14
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- InflaRx Site #07 — Sacramento, California, United States
- InflaRx Site #08 — Miami, Florida, United States
- InflaRx Site #03 — Tampa, Florida, United States
- InflaRx Site #10 — St Louis, Missouri, United States
- InflaRx Site #05 — Columbus, Ohio, United States
- InflaRx Site #12 — Hershey, Pennsylvania, United States
- InflaRx Site #09 — Pittsburgh, Pennsylvania, United States
- InflaRx Site #01 — Richmond Hill, Ontario, Canada
- InflaRx Site #21 — Rzeszów, Poland
- InflaRx Site #20 — Wroclaw, Poland
Full record on ClinicalTrials.gov
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