The purpose of this study is to characterize the pharmacokinetics (PK), pharmacodynamics (PD), and safety of subcutaneous (SC) anifrolumab in pediatric participants with moderate to severe systemic lupus erythematosus (SLE) while on background standard of care (SoC) therapy.
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.
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.
Sequential
Anifrolumab + APFS
Combination productAnifrolumab will be administered as a SC injection using an APFS.
Maximum observed serum (peak) concentration (Cmax)
To characterize PK (Cmax) of anifrolumab in pediatric participants with SLE following SC administration.
Area under the serum concentration-time curve (AUC)
To characterize PK (AUC) of anifrolumab in pediatric participants with SLE following SC administration.
Time to maximum plasma concentration (tmax)
To characterize PK (tmax) of anifrolumab in pediatric participants with SLE following SC administration.
Apparent total body clearance of drug from plasma (CL/F)
To characterize PK (CL/F) of anifrolumab in pediatric participants with SLE following SC administration.
Suppression of type I IFN 21-gene signature
To characterize PD of anifrolumab in pediatric participants with SLE following SC administration.
Change from baseline in anti-double-stranded deoxyribonucleic acid (dsDNA) antibodies
To characterize PD of anifrolumab in pediatric participants with SLE following SC administration.
Change from baseline in complement component 3 (C3) levels
To characterize PD of anifrolumab in pediatric participants with SLE following SC administration.
Change from baseline in complement component 4 (C4) levels
To characterize PD of anifrolumab in pediatric participants with SLE following SC administration.
Number with participants with adverse events (AEs), serious adverse events (SAEs) and adverse events of special interest (AESIs)
To evaluate the safety and tolerability of anifrolumab in pediatric participants with SLE following SC administration.
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