An Open-Label, Multicenter Study to Evaluate the Pharmacokinetics and Safety of Xembify versus Gamunex-C in Participants with Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)

Condition studied

Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP)

Investigational medicinal product(s)

Eligibility

Primary endpoint

AUC in the IV Phase: Steady-state AUC of total IgG over a 3-week dosing interval (τ) (i.e., AUC(0−21days) in participants with CIDP, AUC in the SC Phase: Steady-state AUC of total IgG over a weekly SC dosing interval (τ) (i.e., AUC(0−7days)) in participants with CIDP

Endpoint detail

Steady-state mean trough (pre-dose) concentration of total IgG following IV administration of IGIV-C 10% Q3W or SC administration of IGSC 20% QW.