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)

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.

Eligibility

Age range

18–75 years

Sex

All

Healthy volunteers

No

Interventions

• Combination Product
  Anifrolumab (blinded)

  Anifrolumab treatment delivered subcutaneously, once weekly for 52 weeks

• Other
  Placebo

  Matched placebo delivered subcutaneously, once weekly for 52 weeks

• Combination Product
  Anifrolumab (unblinded, open label)

  At Week 52, all study participants on anifrolumab or placebo will receive open label anifrolumab once weekly for an additional 52 weeks

Locations (234)