Open for Enrollment Soon
This study will open for enrollment soon. Please contact the study team for more information and check back frequently.

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.

What is the Condition Being Studied?

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.

Age Group
Adults

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.

Study Details

Full Title
A Multicenter, Parallel-group, Double-blind, 2-Arm, Phase III Study to Investigate the Efficacy and Safety of Anifrolumab Administered as Subcutaneous Injection and Added to Standard of Care Compared with Placebo Added to Standard of Care in Adult Participants with Idiopathic Inflammatory Myopathies (Polymyositis and Dermatomyositis)
Principal Investigator
Protocol Number
IRB: PRO00118014
NCT: NCT06455449
Phase
Phase III
ClinicalTrials.gov
Enrollment Status
Open for Enrollment Soon
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