A Study to Evaluate the Treatment Outcomes of Subcutaneous Anifrolumab in Immunosuppressant-naïve and Biologic-naïve Systemic Lupus Erythematosus

Prior treatment

• Clinical cytomegalovirus (CMV) or Epstein-Barr virus (EBV) infection that has not completely resolved within 12 weeks prior to signing the ICF
• Clinically significant chronic infection within 8 weeks prior to signing the ICF
• History of, or current diagnosis of, catastrophic antiphospholipid syndrome (APS) within one year prior to signing the ICF.

Other illness

• History of, or current diagnosis of, a clinically significant non-SLE-related vasculitis syndrome .
• Confirmed positive test for hepatitis B serology
• Active hepatitis C infection
• Opportunistic infection requiring hospitalization or IV antimicrobial treatment within 3 years of Week 0 (Day 1)
• Malignancy. History of cancer
• Subjects with antiphospholipid antibody syndrome on stable anticoagulant therapy at an effective dose are allowed if this is not the sole or the predominant feature of their SLE. Subjects with a serious thrombotic event or unexplained pregnancy loss within 1 year before the screening visit are excluded.
  • 3.Subjects with a history of catastrophic antiphospholipid syndrome or saddle embolism are excluded. Subjects with a history of 3 or more unexplained consecutive pregnancy losses would also be excluded.
• Active severe SLE-driven renal disease where protocol-specified standard therapy is insufficient
• History of recurrent infection requiring hospitalization and IV antibiotics

Lab values

• Known history of a primary immunodeficiency, splenectomy, or any underlying condition that predisposes the participant to infection, or a positive result for human immunodeficiency virus (HIV) infection confirmed by central laboratory at Screening.

Other

• Severe Herpes Zostet (HZ) or recurrent HZ
• History or evidence of suicidal ideation (severity of 4 or 5) within the past 6 months; or any suicidal behavior within the past 12 months or recurrent suicidal behavior in the lifetime of the participant
• Active severe or unstable neuropsychiatric SLE

• Males or females aged 18 to 70 years of age inclusive at the time of sigining the ICF
• Participants who have a diagnosis of SLE, confirmed by a rheumatologist, for at least 3 months (≥ 12 weeks) prior to signing the ICF (SLE according to the 2019 EULAR/American College of Rheumatology (ACR) criteria)
• ANA-positive as determined by a documented historical test result confirmed at Screening for Antinuclear antibody (ANA) immunofluorescent assay test (titre ≥ 1:80) or at least one of the following determined at screening: (a) ANA (b) Anti-dsDNA (c) Anti-Smith (anti-Sm)
• Must be receiving the standard therapy regimen: antimalarials with or without OCSs
• Must have at screening and baseline: (a) Clinical SLEDAI-2K ≥ 4 points OR (b) Clinical SLEDAI-2K < 4 with GC dose ≥ 7.5 mg/day (prednisone equivalent)
  • Additional details on inclusion criteria are described in protocol section 5.1 Inclusion Criteria