This study will assess the safety and pharmacokinetic comparability of two VAY736 drug products in patients with rheumatoid arthritis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
48
Human monoclonal antibody (mAb) of type IgG1/κ binding to B-cell activating-receptor (BAFF-R)
Novartis Investigative Site
Berlin, Germany
Novartis Investigative Site
Amman, Jordan
Safety and tolerability as measured by the number of patients with adverse events
The number of patients with adverse events after repeated subcutaneous (s.c) injections of a fixed dose of ianalumab
Time frame: Week 0 - 112
Pharmacokinetic comparability at steady state - AUCtau
The area under the serum ianalumab concentration-time curve from time zero to the end of the dosing interval (AUCtau)
Time frame: Week 8 - 12
Pharmacokinetic comparability at steady state - Cmax
Observed maximum serum concentration of ianalumab following drug administration (Cmax)
Time frame: Week 8 - 12
Pharmacokinetic comparability after the first dose - AUCtau
The area under the serum ianalumab concentration-time curve from time zero to the end of the dosing interval (AUCtau)
Time frame: Week 0 - 4
Pharmacokinetic comparability after the first dose - Cmax
Observed maximum serum concentration of ianalumab following drug administration (Cmax)
Time frame: Week 0 - 4
Pharmacokinetic comparability after the first dose - Tmax
Time to reach the maximum concentration after drug administration (Tmax)
Time frame: Week 0 - 4
Pharmacokinetic comparability of two ianalumab drug products after the last dose - AUCinf
The area under the serum ianalumab concentration-time curve from time zero to infinity (AUCinf)
Time frame: Week 8 - 12
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Pharmacokinetic comparability after the last dose - Tmax
Time to reach the maximum concentration after drug administration (Tmax)
Time frame: Week 8 - 12
Pharmacokinetic comparability after the last dose - T1/2
The terminal elimination half-life (T1/2)
Time frame: Week 8 - 12
Pharmacokinetic comparability at the end of each dosing interval - Ctrough
Observed minimum serum ianalumab concentration following drug administration (Ctrough)
Time frame: Week 0 - 12
Pharmacodynamic effect as measured by B-cell level
Circulating B cells (CD19+)
Time frame: Week 0 - 112
Immunogenicity as measured by Anti-Drug Antibodies
Anti-ianalumab antibodies (ADA); incidence of ADA positive patients and correlation with AEs, PK and clinical outcomes
Time frame: Week 0 - 112