NCT06455449

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)

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)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 240 (estimated)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Polymyositis, Dermatomyositis

Interventions

Type	Name	Description
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

Timeline

• Start date: 2024-06-20
• Primary completion: 2027-05-14
• Completion: 2028-08-04
• First posted: 2024-06-12
• Last updated: 2026-03-19

Locations

228 sites across 29 countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Czechia, Denmark, France, Germany, Hungary, India, Israel, Italy, Japan, Mexico, Netherlands, Poland, Puerto Rico, South Korea, Spain, Sweden, Taiwan, United Kingdom, Vietnam

Regulatory

• FDA-regulated drug study