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.
This is an open-label, multicenter study. The study includes - * Screening Period of up to 35 days * Period A (12-week, open-label treatment period) * Period B (a possible 12-week dosing regimen adjustment period, if required) * Treatment Extension Period (up-to-40-week, optional) * Period C (a 12-week safety follow-up period) The study intervention (anifrolumab) will be administered subcutaneously using an accessorized pre-filled syringe (APFS) in 2 cohorts.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
Anifrolumab 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.
Time frame: Cohort 1: From Day 1 to Day 8; Cohort 2: From Day 1 to Day 11
Area under the serum concentration-time curve (AUC)
To characterize PK (AUC) of anifrolumab in pediatric participants with SLE following SC administration.
Time frame: Cohort 1: From Day 1 to Day 8; Cohort 2: From Day 1 to Day 11
Time to maximum plasma concentration (tmax)
To characterize PK (tmax) of anifrolumab in pediatric participants with SLE following SC administration.
Time frame: Cohort 1: From Day 1 to Day 8; Cohort 2: From Day 1 to Day 11
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.
Time frame: Cohort 1: From Day 1 to Day 8; Cohort 2: From Day 1 to Day 11
Trough drug concentration at steady state (Ctrough,ss)
To characterize PK (Ctrough,ss) of anifrolumab in pediatric participants with SLE following SC administration.
Time frame: At Week 12
Suppression of type I IFN 21-gene signature
To characterize PD of anifrolumab in pediatric participants with SLE following SC administration.
Time frame: At Week 12 and 52
Change from baseline in anti-double-stranded deoxyribonucleic acid (dsDNA) antibodies
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To characterize PD of anifrolumab in pediatric participants with SLE following SC administration.
Time frame: At Week 12 and 52
Change from baseline in complement component 3 (C3) levels
To characterize PD of anifrolumab in pediatric participants with SLE following SC administration.
Time frame: At Week 12 and 52
Change from baseline in complement component 4 (C4) levels
To characterize PD of anifrolumab in pediatric participants with SLE following SC administration.
Time frame: At Week 12 and 52
Change from baseline in total hemolytic complement (CH50) levels
To characterize PD of anifrolumab in pediatric participants with SLE following SC administration.
Time frame: At Week 12 and 52
Number and percentage of participants who develop anti drug antibody (ADA) against anifrolumab
To evaluate the immunogenicity of anifrolumab in pediatric participants with SLE following SC administration.
Time frame: From Day 1 to Week 52