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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 2

A Phase 2, Randomized, Double-blind, Multicenter, Placebo-controlled Study to Evaluate the Efficacy and Safety of Maintenance Ublituximab Treatment Following Induction With Efgartigimod Administration in Adults With Myasthenia Gravis

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
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.

About the study

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

What is being tested

Sponsor: TG Therapeutics, Inc. · Participants: 120 · Started: Oct 1, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT07673744

Locations in the U.S.

ColoradoTG Therapeutics Investigational Trial Site, Colorado Springs
TG Therapeutics Investigational Trial Site, Colorado Springs
FloridaTG Therapeutics Investigational Trial Site, Clearwater
MichiganTG Therapeutics Investigational Trial Site, Farmington Hills
North CarolinaTG Therapeutics Investigational Trial Site, New Bern
South CarolinaTG Therapeutics Investigational Trial Site, Greenville

Conditions

From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.