The purpose of this study is to determine the effect of nipocalimab on total serum immunoglobulin G (IgG) in pediatric participants 2 to less than (\<) 18 years of age (globally) and 8 to \<18 years of age (for Unites Stated (US) sites only), the safety and tolerability of treatment with nipocalimab in children and adolescents and to evaluate the pharmacokinetics (PK) of nipocalimab in children and adolescents with generalized myasthenia gravis (gMG) who have an insufficient clinical response to ongoing, stable standard-of-care therapy.
Age range
2 Years – 17 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Change from Baseline in Total Serum Immunoglobulin-G (IgG) Levels
Timeframe: Up to 3 years
Number of Participants with Infectious Adverse Events (AEs)
Timeframe: Up to 3 years
Number of Participants with Serious AEs (SAEs)
Timeframe: Up to 3 years
Number of Participants with Adverse Events of Special Interests (AESIs)
Timeframe: Up to 3 years
Number of Participants with Abnormalities in Clinical Laboratory Tests
Timeframe: Up to 3 years
Number of Participants with Abnormalities in Vital Signs
Timeframe: Up to 3 years
Number of Participants with Abnormalities in Physical Examination
Timeframe: Up to 3 years
Serum Concentration of Nipocalimab over Time
Timeframe: Up to 3 years
Clearance (CL) of Nipocalimab
Timeframe: Up to 3 years
Volume of Distribution (V) of Nipocalimab
Timeframe: Up to 3 years
Half-life (t1/2) of Nipocalimab
Timeframe: Up to 3 years
Steady-state Peak Concentration (Cpeak,ss) of Nipocalimab
Timeframe: Up to 3 years
Steady-state Trough concentration (Ctrough,ss) of Nipocalimab
Timeframe: Up to 3 years
Steady-state Area Under the Curve (AUCss) of Nipocalimab
Timeframe: Up to 3 years