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)
Amgen_Inebilizumab_OLE
What is the goal of the study?
This is an open-label multicenter study to evaluate the PK, PD, safety and tolerability of inebilizumab in eligible pediatric participants of >= 2 to <18 years of age with autoinmune myasthenia gravis. following a screening period of up to 28 days participants will be enrolled into a 52-week 365-day treatment period where they will receive inebilizumab on day 1 day 15 and day 183. during the treatment period participants will be followed every 4 to 6 weeks up to day 365 or until b cell repletion if later to collect safety pk pd and efficacy assessments. after day 365 week 52 participants will be followed quarterly for at least 26 weeks 52 weeks after their last dose of inebilizumab>
Who can participate in the study?
Please contact the study team listed below to learn more.