The purpose of this study is to assess how well nipocalimab works when compared to efgartigimod in participants with generalized myasthenia gravis (a condition in which body's immune system mistakenly attacks and damages the connection between nerves and muscles causing muscle weakness).
Medically stable on the basis of physical examination, medical history, vital signs, clinical laboratory tests, and 12-lead electrocardiogram (ECG) performed at screening
Diagnosis of myasthenia gravis (MG) with generalized muscle weakness meeting the clinical criteria for generalized MG (gMG) as defined by the Myasthenia gravis foundation of America (MGFA) clinical classification class II a/b, III a/b, or IV a/b at screening and positive for acetylcholine receptor (AChR) antibodies
Myasthenia Gravis-Activities of Daily Living (MG-ADL) score of greater than or equal to (>=) 5 with less than (<) 50% of symptoms coming from ocular MG-ADL sub-scores at study screening and baseline (Day 1) visits
Any confirmed or suspected clinical immunodeficiency syndrome not related to treatment of his/her gMG, or has a family history of congenital or hereditary immunodeficiency unless confirmed absent in the participant
Had a thymectomy within 1 year prior to baseline, or thymectomy is planned during the study
Currently has a malignancy or has a history of malignancy within 3 years before baseline
Parallel
Nipocalimab
DrugNipocalimab will be administered intravenously.
Efgartigimod
DrugEfgartigimod will be administered intravenously.
Arms 1 and 2: Averaged Mean Percent Change from Baseline in Total Immunoglobulin G (IgG) Levels Over Weeks 8, 10 and 12
Average mean percent change from baseline in total IgG levels over Weeks 8 , 10 and 12 will be reported.
Arms 1 and 2: Averaged Mean Change from Baseline in Myasthenia Gravis-Activities of Daily Living (MG-ADL) Total Score Over Weeks 8, 10 and 12
Average mean change from baseline in MG-ADL total score over Weeks 8, 10 and 12 will be reported. The MG-ADL provides a rapid assessment of the participant's MG symptom severity. Eight functions (talking, chewing, swallowing, breathing, impairment of ability to brush teeth or comb hair, impairment of ability to arise from a chair, double vision, eyelid droop) are rated on a 4-point scale: 0 (no impairment) to 3 (severe impairment). The total score will be sum of eight function scores and can range from 0 to 24. A higher score indicates greater symptom severity.
Arms 1 and 2: Mean Percent Change from Baseline in Total IgG Between Arm 1 at EoT and Arm 2 at EoC Based on Clinical Evaluation
Mean percent change from baseline in total IgG between Arm 1 at end of treatment (EoT) and Arm 2 at end of cycle (EoC) based on clinical evaluation will be reported. EoC based on clinical evaluation is defined as the timepoint at which after completion of one cycle of efgartigimod, based on MG-ADL score clinical criteria, the treatment decision would be made to start a second cycle of efgartigimod, an MG rescue medication, or Week 12/EoT, whichever occurs first.
Arms 1 and 2: Mean Percent Change from Baseline in MG-ADL Total Score Between Arm 1 at EoT and Arm 2 at EoC Based on Clinical Evaluation
Mean change from baseline in MG-ADL total score between Arm 1 at EoT and Arm 2 at EoC based on clinical evaluation will be reported. MG-ADL provides a rapid assessment of the participant's MG symptom severity. The total score can range from 0 to 24. A higher score indicates greater symptom severity.
Arms 1 and 2: Mean Percent Change from Baseline in Total IgG Levels at Week 8
Mean percent change from baseline in total IgG levels at Week 8 will be reported.
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