The purpose of this pharmacokinetic (PK) study is to describe the PK profile of ianalumab following s.c. administration in Chinese participants with systemic lupus erythematosus (SLE) and/or Sjögren's disease (SjD). Collection of intensive PK data from Chinese population had been designed in the ianalumab Phase 3 studies of SjD CVAY736A2302 (NCT05349214) and lupus nephritis (LN) CVAY736K12301 (NCT05126277) on an optional basis. This study is conducted to provide supplementary Chinese PK data in addition to the intensive PK data from the two Phase 3 studies .
The study consists of the following periods: * Screening Period: up to 4 weeks * Treatment Period (Week 0 - Week 12) : 12 weeks * Extended Treatment Period (after the completion of Week 12 - Week 52 (End of Treatment (EoT)) : 40 weeks \~ After completion of the 12-week treatment, participants will have the option to enter the Extended Treatment Period. If a participant does not enter the Extended Treatment Period, the EoT visit will be performed at the next planned visit following the completion of Week 12, followed by the Post-treatment Follow-up Period. * Post-treatment Follow-up Period: at least 20 weeks and up to 2 years from the last dose of study treatment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
ianalumab will be provided in a pre-filled Syringe (PFS) of 150 mg/1 mL for s.c. administration. Two injections of 1mL each will be administered monthly.
Area Under the Curve (AUC) calculated to the end of a dosing interval (tau) at steady-state (AUCtau) of ianalumab after the 3rd dose
Venous whole blood samples will be collected for activity-based pharmacokinetics characterization of ianalumab. AUCtau of ianalumab will be summarized with descriptive statistics.
Time frame: Week 8 to 12 (Day 57): Pre-dose, Post-dose (24 hours (hr) +/- 12hr, 72 hr +/- 24 hr, 168 hr +/- 72 hr, 336 hr +/- 72hr, 504 hr +/- 72hr)
Observed maximum blood concentration (Cmax)of ianalumab after the 3rd dose
Venous whole blood samples will be collected for activity-based pharmacokinetics characterization of ianalumab. Cmax of ianalumab will be summarized with descriptive statistics.
Time frame: Week 8 to 12 (Day 57): Pre-dose, Post-dose (24 hours (hr) +/- 12hr, 72 hr +/- 24 hr, 168 hr +/- 72 hr, 336 hr +/- 72hr, 504 hr +/- 72hr)
Time of maximum observed drug concentration occurrence (Tmax) of ianalumab after the 3rd dose
Venous whole blood samples will be collected for activity-based pharmacokinetics characterization of ianalumab. Tmax of ianalumab will be summarized with descriptive statistics.
Time frame: Week 8 to 12 (Day 57): Pre-dose, Post-dose (24 hours (hr) +/- 12hr, 72 hr +/- 24 hr, 168 hr +/- 72 hr, 336 hr +/- 72hr, 504 hr +/- 72hr)
Ctrough of ianalumab at the end of dosing interval
Venous whole blood samples will be collected for activity-based pharmacokinetics characterization of ianalumab. Ctrough of ianalumab will be summarized with descriptive statistics.
Time frame: Week 8 to 12 (Day 57): Pre-dose, Post-dose (24 hours (hr) +/- 12hr, 72 hr +/- 24 hr, 168 hr +/- 72 hr, 336 hr +/- 72hr, 504 hr +/- 72hr)
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
The distribution of adverse events will be done via the analysis of frequencies for treatment emergent Adverse Event (TEAEs), Serious Adverse Event (TESAEs) and Deaths due to AEs, through the monitoring of relevant clinical and laboratory safety parameters.
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Time frame: From date of enrollment till 30 days after end of Treatment, assessed up to approximately 44 months
Anti-ianalumab antibodies (ADA)
Immunogenicity (IG) blood samples will be collected for anti-drug antibodies characterization. ADA of ianalumab will be summarized with descriptive statistics.
Time frame: Day 1 (Baseline), Week 8 to 11 Day 57 (Pre-dose), Week 12 Day 85, Week 24 Day 169, Week 36 Day 253, Week 52 Day 365, Week 68 Day 477 and Week 156 Day 1093
Presence of anti-drug antibodies (ADA)
Immunogenicity (IG) blood samples will be collected to assess the presence ADA of ianalumab.
Time frame: Day 1 (Baseline), Week 8 to 11 Day 57 (Pre-dose), Week 12 Day 85, Week 24 Day 169, Week 36 Day 253, Week 52 Day 365, Week 68 Day 477 and Week 156 Day 1093