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.
Who Can Participate?
Eligibility
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 Range
18-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Looking for Healthy Participants
No
What is Involved?
Description
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.
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
Yes
Spanish Materials Available
No
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
Lisa
Criscione-Schreiber
Protocol Number
PRO00118014
NCT ID
NCT06455449
Phase
III
Enrollment Status
Pending Open to Enrollment