A Phase 1 interventional study of ianalumab in Rheumatoid Arthritis, sponsored by Novartis Pharmaceuticals. Completed at 2 sites in 2 countries. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-12-02.
Sponsored by Novartis Pharmaceuticals · Phase 1, Interventional, and Treatment
This study will assess the safety and pharmacokinetic comparability of two VAY736 drug products in patients with rheumatoid arthritis.
2,888 studies on the registry are indexed under Arthritis, Rheumatoid; 390 are open to participants now.
This study's enrollment of 48 is below the median of 94 across 1,984 interventional studies indexed under Arthritis, Rheumatoid.
Browse Arthritis, Rheumatoid studies →Novartis Pharmaceuticals is the lead sponsor of 2,673 studies on the registry; 228 are open to participants now.
Of its 576 completed or terminated interventional studies of FDA-regulated products, 431 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Powder for solution for injection / infusion
Biological: ianalumab
Solution for injection
Biological: ianalumab
Human monoclonal antibody (mAb) of type IgG1/κ binding to B-cell activating-receptor (BAFF-R)
Also known as: VAY736
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
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
Plan to share: No
This study is completed, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Novartis Pharmaceuticals