Benralizumab in eosinophilic granulomatosis with polyangiitis (EGPA) (MANDARA)

The purpose of this study is to find a more effective treatment for eosinophilic granulomatosis with polyangiitis (EGPA). This study is being done to help determine whether an investigational drug called benralizumab will work and be safe for treating patients with EGPA. An investigational drug is one that is not approved by the United States Food and Drug Administration (FDA) to treat EGPA. Benralizumab is being compared to mepolizumab, which is approved by the FDA to treat EGPA.

YES. You will be randomly assigned to receive either benralizumab and mepolizumab or mepolizumab placebo, or mepolizumab and benralizumab or benralizumab placebo. The study drug is injected under your skin. Placebo means a substance that looks like benralizumab or mepolizumab and is injected in the same way, but it does not have any active drug in it. This is a double-blind study, which means that you and the study team will not know which treatment 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 benralizumab 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
• If you are on immunosuppressive therapy, your dose must be stable

The double-blind period of the study takes about 1 year and involves 17 visits to Penn – during this time you may receive benralizumab or mepolizumab. Once you complete this period, you may have the option to continue in the open-label extension period for at least 1 more year which involves 13 visits to Penn – during this time you will receive benralizumab. You may be in this study for about 2 years.

You are expected to attend all study visits. Each visit will last about 3-4 hours. During some or all of the visits, you will have physical exams, ECG (electrocardiogram), lung function test, nasal secretion collection, blood and urine collection, and you will complete questionnaires and keep a daily diary. You may also choose to participate in an optional sub-study, during which you would have 2 tissue biopsies collected from your nose and additional blood samples.

Thank you for your interest! If you wish to learn more and sign up for the study, please contact:

SARAH GILLESPIE
rheumatologyresearch@uphs.upenn.edu
215-614-4417