clinical trial · 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)
AstraZeneca·phase3·recruiting·n = 240
Polymyositis, DermatomyositisAnifrolumab (blinded)PlaceboAnifrolumab (unblinded, open label)
brief 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.
started
Jun 20, 2024
primary completion
May 14, 2027
completion
Aug 4, 2028
last updated
Apr 21, 2026
official 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)
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol