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

RecruitingPhase 2Ages 18 Years - anyAllTG Therapeutics, Inc.
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In plain words

What the trial is, and whether it could suit you

The primary purpose of this study is to evaluate the efficacy of ublituximab in adult participants with MG responding to treatment with efgartigimod.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: 1. Documentation of MG diagnosis. 2. Eligible for treatment with efgartigimod per effective local product label, confirmed by serological testing at screening. 3. 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. Exclusion Criteria: 1. 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.). 2. Lack of efficacy or observed safety concerns from prior neonatal Fc receptor (FcRn) treatment. 3. 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. 4. Participants with significantly impaired organ function. 5. History of life-threatening injection/infusion related reaction (IRR/ISR), hypersensitivity, or anaphylactic reaction with components of efgartigimod or ublituximab solutions, protocol-allowed rescue medications, or protocol required pre-treatment medications. 6. Unwillingness or inability to comply with study and/or follow-up procedures outlined in the protocol. Note: Other protocol-specified Inclusion/Exclusion criteria may apply.
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What it tests

  • Ublituximab
  • Placebo
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Where

6 sites
TG Therapeutics Investigational Trial Site
Colorado Springs, United States
TG Therapeutics Investigational Trial Site
Colorado Springs, United States
TG Therapeutics Investigational Trial Site
Clearwater, United States
TG Therapeutics Investigational Trial Site
Farmington Hills, United States
TG Therapeutics Investigational Trial Site
New Bern, United States
TG Therapeutics Investigational Trial Site
Greenville, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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