A Study to Evaluate the Pharmacokinetics (PK), Pharmacodynamics (PD), Efficacy, and Safety of Anifrolumab in Children with Moderate to Severe Active Systemic Lupus Erythematosus (SLE)
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 3 months prior to signing the ICF.
Female participants of childbearing potential must have a negative serum pregnancy test at screening and negative urine pregnancy test at randomization.
Female participants of childbearing and male participants must adhere to the contraception methods.
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.
AstraZeneca
Lead sponsor