Currently Enrolling Polymyositis Studies
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)
- Population: Participants must be between 18 and 75 years old at the time of signing informed consent. Body weight must range from 40 kg to 100 kg during screening.
- Study Condition: Disease diagnosis, severity, and activity require a "probable" or "definite" diagnosis of Polymyositis (PM) or Dermatomyositis (DM) according to the 2017 EULAR/ACR classification criteria for adult myositis.
- Study Design: A Phase III study to evaluate the efficacy and safety of anifrolumab in adult participants with moderate to severe active IIM (PM/DM) while receiving stable standard of care therapy.
- Duration: participant is approximately 122 weeks which consists of the screening period (up to 6 weeks), the placebo-controlled, Double-blind Treatment Period (52 weeks), the Open-label Treatment Period (52 weeks), and the safety Follow-up Period (12 weeks).
- Compensation is provided for participation