JASMINE - Clinical Trial
What is the Purpose of this Study?
You will be in this study for about 122 weeks. The study has three parts called Screening, Treatment, and Follow up. During screening, which can last up to six weeks, doctors will do tests to see if you can join. If you qualify, you will be placed by chance into one of two groups. One group will get a study drug called anifrolumab, and the other will get a placebo, which looks like the medicine but has no active drug. You will also keep taking your regular medicines for polymyositis or dermatomyositis. You must stay on the same dose of your regular medicines for at least the first eight weeks of the study.
This study is for people who have idiopathic inflammatory myopathies, which are diseases that cause muscle weakness and inflammation. The two main types in this group are polymyositis and dermatomyositis.
Who Can Participate in the Study?
People can join this study if they are 18 years or older and weigh between 88 and 220 pounds. They must have moderate to severe polymyositis or dermatomyositis. They cannot have taken anifrolumab before, and they cannot have very serious muscle damage.
What is Involved?
The main purpose of this study is to find out if adding a medicine called anifrolumab to your regular treatment helps improve symptoms of polymyositis or dermatomyositis more than a placebo. The study also wants to see if anifrolumab can help lower the amount of steroid medicine you need to control your disease.