A 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)

Summary

The purpose of this multicenter, randomized, placebo-controlled and double-blind study is to evaluate the efficacy and safety of subcutaneous anifrolumab compared with placebo on the overall disease activity in participants with moderate to severe Idiopathic Inflammatory Myopathies (IIM) \[polymyositis (PM) or dermatomyositis (DM)\] while receiving standard of care (SoC) treatment.

Timeline

Start

2024-06-20

Primary completion

2028-01-10

Completion

2029-04-09

Publications

• Soares RB, Gabr JB, Ash M, Hosler G. Anifrolumab in Refractory Dermatomyositis and Antisynthetase Syndrome. Case Rep Rheumatol. 2025 Apr 21;2025:5560523. doi: 10.1155/crrh/5560523. eCollection 2025.

Drugs

Indications