The primary objectives of this study are to characterize the pharmacokinetics (PK) and pharmacodynamics (PD) of inebilizumab administered in pediatric participants with gMG, and to assess the safety and tolerability of inebilizumab administered in pediatric participants with gMG.
Participant's legally authorized representative has provided informed consent when the participant is legally too young to provide informed consent and the participant has provided written assent based on local regulations and/or guidelines before any study-specific activities/procedures being initiated.
Age ≥ 2 to < 18 years of age on the day of enrollment.
Positive serologic test for anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody (Ab) titers as confirmed at screening (1 retest allowed), and
History of abnormal neuromuscular transmission test results demonstrated by single-fiber electromyography or repetitive nerve stimulation; or
Employees of the Sponsor, contract research organization (CRO), site staff, and their family members.
Thymectomy within 12 months prior to baseline (Day 1) visit or planned thymectomy during the duration of the treatment period.
Unresected thymoma- Participants with benign thymoma resected > 12 months prior to screening may enroll.
History of recurrent significant infections.
Single group
Inebilizumab
DrugInebilizumab will be administered IV.
Maximum Observed Concentration (Cmax) of Inebilizumab
Area Under the Concentration-time Curve (AUC) of Inebilizumab
Half-life (t1/2) of Inebilizumab
Clearance (CL) of Inebilizumab
Change from Baseline in Quantitative Myasthenia Gravis (QMG) Score
Change from Baseline in Myasthenia Gravis Activities of Daily Living (MG-ADL) Score
Change from Baseline in Euro Quality of Life-5 Dimension Youth (EQ-5D-Y) Score
Change from Baseline in Neurological Quality of Life (Neuro-QoL) Pediatric Fatigue Score
