Open-label, Uncontrolled, Multicenter Trial to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Inebilizumab in Children From 2 Years to Less Than 18 Years of Age with Immunoglobulin G4 related Disease (IgG4-RD)

Condition studied

Immunoglobulin G4 related Disease (IgG4-RD)

Investigational medicinal product(s)

Eligibility

Primary endpoint

• PK parameters, including maximum plasma concentration (Cmax), area under the plasma concentration-time curve (AUC), terminal half-life (t½), clearance (CL), and volume of distribution at steady-state (Vss), • Change from baseline in CD20+ B cell counts, • Incidence of adverse events, serious adverse events, events of interest (EOIs), and change from baseline in laboratory parameters and vital signs

Endpoint detail

• Disease activity endpoints include: - Time-to-first treated flare across 52 weeks - Proportion of flare-free participants across 52 weeks - Annualized flare rate across 52 weeks, • Presence of antidrug antibodies (ADA) before and after initiation of treatment, • Percent reduction from baseline in daily glucocorticoid dose at week 52 taken for the purpose of IgG4 RD control