Study

Exploring Anifrolumab as a Treatment Option for People with Polymyositis and Dermatomyositis

In this study, we want to learn whether adding anifrolumab to standard treatment for people with polymyositis (PM) and dermatomyositis (DM) works better than standard treatment alone. We also want to learn more about how PM and DM affect the body.

Why this Research Matters

Idiopathic inflammatory myopathies (IIM) are a group of autoimmune diseases where the immune system attacks healthy parts of the body. Polymyositis (PM), which affects the muscles and dermamyositis (DM), which affects the skin, are two types of IIM. Anifrolumab is a drug approved for treating lupus. In this study, it is being tested as a way to treat PM or DM better. Before you can join this study, you will come to the clinic for a visit. At this visit, we will ask you questions about your health, do a physical exam, and collect blood. We will also do an X ray or CT scan and a COVID-19 test. If necessary, we will do a pregnancy test and a cervical cancer test. If you qualify for the study and decide to take part, you will complete two different phases. In phase 1, you will be randomly assigned to one of two groups, like flipping a coin. One group will be given the study drug anifrolumab, and the other group will be given a placebo. A placebo looks the same and is taken the same as the study drug but has no active medicine. Neither you nor the study team will know which treatment you are receiving. You will be given your study drug once a week for about a year. In phase 2 of the study, everyone will be given anifrolumab once a week for about a year. You will be in this study for about 2 years. You will have up to 20 visits in the study. You can earn up to $2,200 for completing all study visits. There is no cost to take part in this study. You and your insurance will have to pay for your regular medical care.

Who can Participate

Adult

You may be able to join this study if you are between the ages of 18 and 75 years old, weigh between 88 and 220 pounds, and have PM or DM. You must also be currently receiving treatment for PM or DM. You cannot join this study if you have inclusion body myositis, immune-mediated necrotizing myopathy, or juvenile myositis. You also cannot join if you have drug-induced PM or DM, cancer associated PM or DM, amyopathic DM, or noninflammatory myopathies. The study team will review the other study requirements with you and decide whether you can join the study.