The primary purpose of this study is to evaluate the efficacy of ublituximab in adult participants with MG responding to treatment with efgartigimod.
Documentation of MG diagnosis.
Eligible for treatment with efgartigimod per effective local product label, confirmed by serological testing at screening.
MG-ADL score at the time of screening more than or equal to (≥) 6 and less than or equal to (≤) 10 with more than (>) 50 percent (%) of this score attributed to non-ocular items, or an MG-ADL score ≥ 11.
Active chronic (or stable but treated with immune therapy) disease of the immune system other than MG (e.g., rheumatoid arthritis, scleroderma, Sjögren's syndrome, Crohn's disease, ulcerative colitis, etc.) or immunodeficiency syndrome (hereditary immune deficiency, drug-induced immune deficiency, etc.).
Lack of efficacy or observed safety concerns from prior neonatal Fc receptor (FcRn) treatment.
Prior treatment with B-cell depleting therapy, alemtuzumab, total lymphoid irradiation, bone marrow transplant, T-cell vaccination therapy, or natalizumab at any time prior to screening.
Participants with significantly impaired organ function.
Parallel
Ublituximab
DrugAdministered as an IV infusion.
Placebo
DrugAdministered as an IV infusion.
Time to Onset of a Clinical Worsening Event
Number of Participants with Treatment-Emergent Adverse Events (TEAEs)
Maximum Plasma Concentration (Cmax) of Ublituximab
Proportion of Participants with Cluster of Differentiation 19 + (CD19+) B-cell Counts
Change From Baseline in Myasthenia Gravis-Activities of Daily Living (MG-ADL) Total Score in RCP
The MG-ADL scale focuses on relevant symptoms and functional performance of activities of daily living in participants with MG. The total score varies between 0-24, with higher score indicating more severe disease.
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