Randomized, Double-blind, Placebo-controlled, Phase II Study to Investigate Safety and Efficacy of 2 Different Dose Regimens of IFX-1 as Add-on to Standard of Care for GPA and MPA
Brief description of study
This clinical
research study will look at an investigational study drug called IFX-1. It is
being investigated for the first time in people who have granulomatosis with
polyangiitis (GPA) and microscopic polyangiitis (MPA). “Investigational” means
that the study drug is currently being tested and is not approved for sale in
the United States by the Food and Drug Administration. The study will investigate 2 different doses of the
study drug compared with a placebo when given in combination with standard of
care treatments. A placebo looks like the study drug but contains no active
ingredients.
Participation will
last about 7 months and requires about 14 visits to Penn. The study
drug/placebo is given over 30‒60 minutes intravenously (in your vein). You will also answer
questionnaires, give blood and urine samples, and other procedures.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
-
Conditions:
GPA,MPA,granulomatosis with polyangiitis,microscopic polyangiitis,vasculitis
-
Age: Between 18 Years - 89 Years
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Gender: All
Updated on
05 Jul 2023.
Study ID: 831283
