A Phase 2 Open-label Multicenter Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Inebilizumab in Children From 2 Years to less than 18 Years of age With Generalized Myasthenia Gravis (gMG)

Condition studied

Generalized Myasthenia Gravis

Investigational medicinal product(s)

Eligibility

Primary endpoint

"Pharmacokinetic parameters, including maximum observed concentration (Cmax), area under the concentration-time curve (AUC), half-life (t1/2), clearance (CL) and volume of distribution at steady state (Vss)", Change from baseline in cluster of differentiation 20 (CD20)+ B-cell counts, "Incidence of treatment-emergent adverse events, treatment-emergent serious adverse events, adverse events of interest", Changes in laboratory parameters, Changes in vital signs

Endpoint detail

Change in Quantitative Myasthenia Gravis (QMG) score, Change in Myasthenia Gravis Activities of Daily Living (MG-ADL) score, Presence of anti-drug antibodies (ADAs), "Change in Euro Quality of Life-5 Dimension Youth score", "Change in Neurological Quality of Life Pediatric Fatigue score"