A Study to Evaluate Vilobelimab for the Treatment of Ulcerative Pyoderma Gangrenosum
Official Title
A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Adaptive Phase III Trial To Investigate Efficacy And Safety Of Viobelimab In The Treatment Of Ulcerative Pyoderma Gangrenosum
Purpose
This study aims to find out if a new investigational drug, vilobelimab (also called IFX-1) is safe and effective in treating pyoderma gangrenosum.
The study will measure if the study drug closes the ulcers of your skin. It will also measure if the study drug improves the severity of your disease (according to the study doctor and according to you) and if it improves your pain and your quality of life.
Could this study be right for you?
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Investigator confirmed clinical diagnosis of ulcerative pyoderma gangrenosum (PG).
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Minimum of 1 PG ulcer (other than peristomal) which qualifies as the target ulcer
- Area of at least 5 cm2 at screening and baseline
- Circulated by intact skin
- Evaluable by at least 2-dimensional measurement