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)
Key facts
- Phase
- Phase 3
This trial has no sites in United States.
It has sites in 13 countries. Choose a country to see its sites.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record
Print a page for my doctorTrial details
- Who runs it
- AstraZeneca AB
- Trial code
- EU 2023-504022-19-01
- Record updated
- 28 September 2026
- Original description
To demonstrate the superiority of anifrolumab to placebo on moderate improvement in disease activity at Week 52Read full original descriptionShow less
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)
To demonstrate the superiority of anifrolumab to placebo on moderate improvement in disease activity at Week 52
Inclusion: 18 - 75 years old; Body weight 40 kg - ≤ 100 kg; Must have “probable” or “definite” diagnosis of PM or DM according to the 2017 ACR/EULAR classification criteria for adult myositis; Moderate or severe disease activity per core set measurements; Currently receiving oral prednisone or other polymyositis or dermatomyositis treatments at a stable dose; No history of active tuberculosis or severe COVID-19; Male and female participants must follow contraception guidelines.
Exclusion: Participants with documented inclusion body myositis (IBM), immune mediation necrotizing myositis (IMNM), juvenile myositis (if diagnosed within 10 years prior to signing the ICF), drug-induced myositis, cancer associated myositis, amyopathic DM, and non inflammatory myopathies (eg, muscular dystrophies); Recent or concurrent enrollment in another clinical study with an investigational product; Any clinical cytomegalovirus or Epstein-Barr virus infection that has not completely resolved within 12 weeks prior to signing the ICF; Opportunistic infection requiring hospitalization or IV antimicrobial treatment within 3 years prior to randomization; PM and DM patients at a high risk of malignancy; Participants with rapidly progressive interstitial lung disease; Participants with severe muscle damage or permanent weakness due to non-PM or non-DM conditions (i.e. stroke) as per the investigator's opinion; Any history of severe case of herpes zoster infection; History of cancer (except adequately treated basal cell carcinoma or cervical cancer in-situ), immunodeficiency, HIV, HBV, active HCV ; Recent non-opportunistic infection requiring hospitalization or anti-infective treatment; Lactating, breastfeeding, or pregnant females or females who intend to become pregnant or begin breastfeeding.