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
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.
- Study Identifier: 831283