A Study to Investigate Pharmacokinetics, Pharmacodynamics, and Safety of Subcutaneous Anifrolumab in Pediatric Participants 5 to < 18 Years of Age with Systemic Lupus Erythematosus

Inclusion Criteria

• Inclusion Criteria:
• - Diagnosis of SLE.
• - Must be receiving at least one of the following SoC regimens for ≥ 4 weeks: oral glucocorticoids (≤1.0 mg/kg/day or ≤ 40 mg/day prednisone equivalent), antimalarials (hydroxychloroquine, chloroquine, or quinacrine), or a single permitted immunosuppressant (azathioprine, mycophenolate mofetil/mycophenolic acid, methotrexate, mizoribine, or tacrolimus) within specified dose limits.
• - Participant must have moderate to severe active SLE disease defined as Systemic lupus erythematosus disease activity index 2000 (SLEDAI-2K) ≥ 6 total points.
• - Body weight ≥ 15 kg.
• - Participants must agree to follow study specific contraception requirements as per local regulations.
• Exclusion Criteria:
• - Known diagnosis of an IFN mediated autoinflammatory interferonopathy.
• - History of, or current diagnosis of, clinically significant non-SLE related vasculitides.
• - Active, severe SLE-driven renal disease with significant proteinuria.
• - Active severe or unstable neuropsychiatric SLE including but not limited to aseptic meningitis; cerebral vasculitis; myelopathy; demyelination syndromes (ascending, transverse, acute inflammatory demyelinating polyradiculopathy); acute confusional state; impaired level of consciousness; psychosis; acute stroke or stroke syndrome; cranial neuropathy; status epilepticus; cerebellar ataxia; and mononeuritis multiplex.
• - In participants ≥ 11 years of age, a history or evidence of suicidal ideation (severity of 4 [active: method and intent, but no plan] or 5 [active: method, intent, and plan]) within the past 6 months; or any suicidal behavior within the past 12 months or recurrent suicidal behavior in the lifetime of the participant based on an assessment with the Columbia suicide severity rating scale (C-SSRS).
• - History of, or current diagnosis of, catastrophic antiphospholipid syndrome (APS).
• - History of recurrent or opportunistic infection requiring hospitalization and intravenous (IV) antibiotics.
• - 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.
• - Active hepatitis B and C infection.
• - Any active or recent herpes zoster (HZ) infection that has not completely resolved within 12 weeks prior to study entry or that emerges between screening and Day 1.
• - Any history of severe or recurrent HZ, including non-cutaneous HZ, herpes encephalitis, ophthalmic herpes, or 2 or more prior HZ episodes.
• - Any cytomegalovirus (CMV) or Epstein Barr virus (EBV) infection that has not completely resolved.
• - History of cancer.
• - Prior receipt of anifrolumab.
• - Prior treatment with directly acting cytotoxic B-cell depleting therapeutics.
• - A known history of allergy or reaction to any component of the study intervention formulation or history of anaphylaxis to any human gamma globulin therapy, human proteins, or monoclonal antibodies (mAbs).