Study to Investigate the Efficacy and Safety of NS-229 in the Treatment of Eosinophilic Granulomatosis with Polyangiitis

The main purpose of this study is to learn how well the investigational drug NS-229 works and how safe NS-229 is compared with placebo.  An investigational drug is one that is not approved by the United States Food and Drug Administration (FDA) to treat EGPA.

YES. You would be randomly assigned into 1 of 2 groups.  One group receives NS-229 and the other group receives placebo. You would have about 67% (2 in 3) chance of receiving NS-229 and about 33% (1 in 3) chance of receiving placebo. Placebo means a substance that looks like NS-229, but it does not have any active drug in it.  The study drug is taken by mouth.  This is a double-blind study, which means that you and the study team will not know which group you are in.

We will use your personal health information, information from the tests and procedures done for the study, and information about how the study drug affects you to help determine if NS-229 is safe and effective in treating EGPA.

There are many factors that determine if you are eligible. Some requirements include:

• Adults with EGPA diagnosis and a history of relapsing or refractory disease
• You are on a stable daily dose of 7.5 mg or more of prednisone

You could be in the study for about 9 months.  You would need to come to Penn for at least 11 study visits over this period.

You are expected to attend all study visits. Each visit will last about 3-4 hours except for Day 1 which is longer. During some or all of the visits, you will have physical exams, ECG (electrocardiogram), lung function test, blood and urine collection, and you will complete questionnaires and keep a daily diary.

Thank you for your interest! If you wish to learn more, please contact:

Daniel Killion

rheumatologyresearch@uphs.upenn.edu

215-614-4417