Ublituximab maintenance after efgartigimod response in myasthenia gravis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 2 interventional trial evaluating the safety and efficacy of maintenance ublituximab in adults with MG who have responded to efgartigimod treatment. Participants must be eligible for efgartigimod and have a baseline MG-ADL score within a defined range, with a substantial portion of impairment non-ocular. The study compares ublituximab to placebo to determine if ongoing B-cell depletion confers additional benefit after initial response. Key exclusion criteria include other active immune-related diseases and prior exposure to certain B-cell–depleting or immune therapies. The trial is sponsored by TG Therapeutics with sites in Colorado and Florida.

Why it matters

Who can join: the full rules

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.

Where it's running

• TG Therapeutics Investigational Trial Site
  Colorado Springs, Colorado, United States Recruiting
• TG Therapeutics Investigational Trial Site
  Colorado Springs, Colorado, United States Recruiting
• TG Therapeutics Investigational Trial Site
  Clearwater, Florida, United States Recruiting
• TG Therapeutics Investigational Trial Site
  Maitland, Florida, United States Recruiting
• TG Therapeutics Investigational Trial Site
  Farmington Hills, Michigan, United States Recruiting
• TG Therapeutics Investigational Trial Site
  New Bern, North Carolina, United States Recruiting

Study contacts

• Study coordinator: TG Therapeutics Clinical Support Team
• Email: clinicalsupport@tgtxinc.com
• Phone: 1-877-575-8489

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.