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.
Parallel
Anifrolumab
Biological/VaccineParticipants will receive anifrolumab via IV infusion.
Placebo
DrugParticipants will receive matching placebo via IV infusion
Part A- Anifrolumab serum concentration
The serum concentration will be characterised and the dose of anifrolumab will be defined in pediatric participants with moderate to severely active SLE.
Part A - Maximum observed serum (peak) drug concentration (Cmax)
The serum PK will be characterised and the dose of anifrolumab will be defined in pediatric participants with moderate to severely active SLE.
Part A - Area under the serum concentration curve (AUC)
The serum PK will be characterised and the dose of anifrolumab will be defined in pediatric participants with moderate to severe active SLE.
Part A - Minimum observed serum concentration (Cmin)
The serum PK will be characterised and the dose of anifrolumab will be defined in pediatric participants with moderate to severe active SLE.
Part B - Number of participants who are Systemic Lupus Erythematosus Responder Index of ≥ 4 SRI(4) responders (yes/no)
SRI-4 response is defined as: * ≥ 4-point reduction from baseline in SLEDAI-2K score. * No new organ systems affected as defined by ≥ 1 new BILAG-2004 A or ≥ 2 new BILAG-2004 B items compared to baseline. * No worsening from baseline in participant's lupus disease activity, defined by an increase ≥ 0.30 points on a PGA 3-point VAS.
Part B - Time to first flare
Time to first flare, where flare is defined as either ≥ 1 new BILAG-2004 A, or ≥ 2 new BILAG-2004 B items compared with the previous visit.
Part B - Anifrolumab serum concentration
The PK of anifrolumab in pediatric participants with moderate to severe active SLE will be characterized.
Part - B Change from baseline through Week 52 in antidrug antibody (ADA)
The immunogenicity of anifrolumab in pediatric participants with moderate to severe active SLE will be characterized.
All parts - Number of participants reporting suicidal ideation and/or suicidal behavior as per Columbia Suicide Severity Rating Scale (C-SSRS)
The safety and tolerability of anifrolumab in pediatric participants with moderate to severe active SLE will be assessed.
All parts - Number of participants with adverse events
The safety and tolerability of anifrolumab in pediatric participants with moderate to severe active SLE will be assessed.
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