Comparative Efficacy of Nipocalimab and Efgartigimod in Participants With Generalized Myasthenia Gravis

Inclusion criteria:

For all arms:

• Medically stable on the basis of physical examination, medical history, vital signs,clinical laboratory tests, and 12-lead electrocardiogram (ECG) performed atscreening

• Diagnosis of myasthenia gravis (MG) with generalized muscle weakness meeting theclinical criteria for generalized MG (gMG) as defined by the Myasthenia gravisfoundation of America (MGFA) clinical classification class II a/b, III a/b, or IVa/b at screening and positive for acetylcholine receptor (AChR) antibodies

• Myasthenia Gravis-Activities of Daily Living (MG-ADL) score of greater than or equalto (>=) 5 with less than (<) 50% of symptoms coming from ocular MG-ADL sub-scores atstudy screening and baseline (Day 1) visits

Criteria specific to Arms 1 and 2 only:

• Has suboptimal response to current stable therapy for gMG according to the investigator or has discontinued corticosteroids and/or immunosuppressants/immunomodulators including eculizumab or other novel approved immune agents at least 4 weeks prior to baseline due to intolerance or lack of efficacy

Criteria specific to Arm 3:

• Treatment with efgartigimod IV or subcutaneous (SC) for >=1 cycle, and the final cycle is consistent with product information

Exclusion criteria:

• Any confirmed or suspected clinical immunodeficiency syndrome not related totreatment of his/her gMG, or has a family history of congenital or hereditaryimmunodeficiency unless confirmed absent in the participant

• Had a thymectomy within 1 year prior to baseline, or thymectomy is planned duringthe study

• Currently has a malignancy or has a history of malignancy within 3 years beforebaseline

Criteria specific to Arms 1 and 2 only:

• Has received treatment for MG with an FcRn-targeting therapy

Criteria specific to Arm 3 only:

• Is currently taking IgG monoclonal antibody therapeutics, or Fc-conjugated therapeutic agents, including factor or enzyme replacement, with the exception of efgartigimod