A Study of Nipocalimab in Participants With Active Idiopathic Inflammatory Myopathies

To join this study, you must be an adult aged 18 or over. You need to have been diagnosed with an idiopathic inflammatory myopathy (IIM), or myositis, for at least six weeks before the study starts, and your condition must be active. Doctors will use specific guidelines to confirm your diagnosis.

An important part of eligibility is having certain 'myositis-specific' antibodies in your blood. These antibodies help doctors understand the specific type of myositis you have. You'll have blood tests to check for these antibodies. If you're using certain skin creams for your condition, such as mild steroid creams or tacrolimus, the dose needs to have been stable for at least four weeks before starting the study and kept the same throughout most of the study.

There are also reasons why you might not be able to join. For example, if you were diagnosed with myositis when you were a child and are now an adult, you wouldn't be eligible. Also, if you have myositis linked to cancer, you wouldn't be able to take part in this particular study.

The study involves several visits to the clinic over a period of time. You will be assigned to either receive the study drug (Nipocalimab) or a placebo, and you won't know which one you're getting. You'll also continue to receive any steroid medications (glucocorticoids) your doctor has prescribed for your condition. During your visits, the research team will perform various assessments, including blood tests, physical examinations, and asking you questions about how you're feeling and how your symptoms are changing. These assessments help the researchers understand how the study drug affects your condition and to monitor your health. The total duration of your participation in the study, including follow-up, will be determined by the study design, potentially up to 52 weeks.