Were you diagnosed with Immune-Mediated Necrotizing Myopathy < 1 year ago?

What is SUMMIT?

SUMMIT is a randomized, placebo-controlled research study of ublituximab in early, active autoantibody positive immune-mediated necrotizing myopathy.

Ublituximab is an investigational infusion drug that targets specific immune cells called B cells. B cells sometimes produce antibodies against your body causing muscle inflammation leading to weakness and disability.

What will happen if I join the research study?

The participants will be randomly assigned either to get ublituximab or placebo for the first 24 weeks, then both groups will receive ublituximab at week 24 and 48. There are 15 study visits over about 18 months.

To participate in SUMMIT you must have:

• early stage of the disease (less than 1 year since your myositis started) with positive specific antibodies
• receiving an immunosuppressive treatment for at least 12 weeks before receiving the study drug.

CONTACT: Dr. Julie Paik, Principal Investigator

Johns Hopkins Bayview Medical Center—Rheumatology, Phone: 410-550-1741

Zuzana Bologna, study coordinator, Phone: 706-284-3630

JHMI IRB00507215