A Study to Evaluate the Efficacy and Safety of Maintenance Ublituximab Following Induction With Efgartigimod Administration in Participants With Myasthenia Gravis (MG)

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorTG Therapeutics, Inc.

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

Treatment groups

120 Participants
are divided into 2 treatment groups

Sponsors and collaborators