Two-period Crossover Study to Demonstrate the Comparability of Pharmacokinetics of Subcutaneous Ianalumab Between 2mL Auto-injector/2mL PFS with1mL Pre-filled Syringe in Adult Participants With Autoimmune Disease

Condition(s) studied

Investigational drug(s) / intervention(s)

VAY736 1ml PFS: Solution for injection.

VAY736 2 ml PFS: Solution for injection

VAY736 2ml AI: Solution for injection.

Study summary

The purpose of this study is to demonstrate the comparability of ianalumab exposure following the sub-cutaneous (s.c.) administration of one injection of 300 mg/2 mL auto-injector (AI) versus two injections of 150 mg/1 mL pre-filled syringe (PFS), and to evaluate the safety and tolerability of ianalumab following the s.c. administration of both devices in participants with rheumatoid arthritis (RA), Sjögren's disease (SjD), or systemic lupus erythematosus (SLE).

A second cohort will be included with the objective of demonstrating the comparability of pharmacokinetics of ianalumab between 1 x 2 mL Pre-filled Syringe (PFS) and 2 x 1 mL PFS.

Eligibility

Primary outcome measure(s)

• Cohort 1: Area under the curve (AUC) calculated to the end of a dosing interval (tau) at steady-state (AUCtau) for ianalumab — Over a dosing interval after 3rd (between Week 8 and 12) and 6th dose (between Week 20 and 24).
  To demonstrate the pharmacokinetics (PK) comparability of ianalumab 300 mg s.c. at steady state between the 1 x 2 mL AI and 2 x 1 mL PFS
• Cohort 1: Maximum (peak) observed serum drug concentration after dose administration (Cmax) for ianalumab — Over a dosing interval after 3rd (between Week 8 and 12) and 6th dose (between Week 20 and 24).
  To demonstrate the pharmacokinetics (PK) comparability of ianalumab 300 mg s.c. at steady state between the 1 x 2 mL AI and 2 x 1 mL PFS
• Cohort 2: Area under the curve (AUC) calculated to the end of a dosing interval (tau) at steady-state (AUCtau) for ianalumab — Over a dosing interval after 3rd (between Week 8 and 12) and 6th dose (between Week 20 and 24).
  To demonstrate the pharmacokinetics (PK) comparability of ianalumab 300 mg s.c. at steady state between the 1 x 2 mL PFS and 2 x 1 mL PFS.
• Cohort 2: Maximum (peak) observed serum drug concentration after dose administration (Cmax) for ianalumab — Over a dosing interval after 3rd (between Week 8 and 12) and 6th dose (between Week 20 and 24).
  To demonstrate the pharmacokinetics (PK) comparability of ianalumab 300 mg s.c. at steady state between the 1 x 2 mL PFS and 2 x 1 mL PFS.

Trial sites (37)

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