About this trial
The primary purpose of this study is to evaluate the efficacy of ublituximab in adult participants with MG responding to treatment with efgartigimod.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Ublituximab
- Placebo