An Efficacy and Safety Study of Intravenous Anifrolumab to Treat Systemic Lupus Erythematosus in Pediatric Participants

Eligibility Criteria

• * Participant's parent/caregiver/legally authorized representative and participant (if required per local country regulation) capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol. Informed assent is to be provided by the participant per local country regulation.
• * Diagnosis of SLE according to the 2019 European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) criteria.for at least 6 months prior to signing the ICF.
• * Participant should meet all of following tuberculosis (TB) criteria:
• * Female participants of childbearing potential must have a negative pregnancy test at Screening.
• * Female participants of childbearing and non-childbearing potential and male participants must adhere to the contraception methods.
• * At screening, negative SARS-CoV-2 RT-PCR or rapid antigen test result and no known or suspected COVID-19 infection or exposure between screening and randomization visits.
• * Known diagnosis of an IFN-mediated autoinflammatory interferonopathy.
• * History of, or current diagnosis of, clinically significant non-SLE-related vasculitides.
• * In participants aged 11 years and above: history or evidence of suicidal ideation.
• * History of any non-SLE disease that has required treatment with oral or parenteral corticosteroids for more than a total of 2 weeks within the last 24 weeks prior to signing the ICF.
• * Any positive result on Screening for human immunodeficiency virus.
• * Active hepatitis B surface antigen OR hepatitis B core antibody (HBcAb), hepatitis C virus (HCV) antibody and detectable HCV ribonucleic acid (RNA) or any severe case of Herpes Zoster infection.
• * Any clinical cytomegalovirus or Epstein-Barr virus infection that has not completely resolved within 12 weeks prior to signing the ICF.
• * History of severe COVID-19 infection requiring hospitalization, intensive care unit care, or assisted ventilation or any prior COVID-19 infection with unresolved sequelae. Any mild/asymptomatic COVID-19 infection (laboratory confirmed or suspected based on clinical symptoms).
• * Prior use of Anifrolumab.
• * Prior treatment with directly acting cytotoxic B-cell depleting therapeutics (eg, rituximab) \< 26 weeks prior to ICF signature.
• * Blood transfusion or receipt of blood products except albumin within 4 weeks prior to signing the ICF.