A Study to Evaluate the Efficacy and Safety of Maintenance Ublituximab Following Induction With Efgartigimod Administration in Participants With Myasthenia Gravis (MG)
Recruiting now · Phase 2 · Has a placebo group
Conditions studied: Myasthenia Gravis
In brief
The primary purpose of this study is to evaluate the efficacy of ublituximab in adult participants with MG responding to treatment with efgartigimod.
Key facts
- Study ID
- NCT07673744
- Run by
- TG Therapeutics, Inc.
- People needed
- 120
- Starts
- 2026-07-30
- Expected to finish
- 2030-01-01
- Last updated by the study team
- 2026-07-17
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
- 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.
- 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 is running
- TG Therapeutics Investigational Trial Site — Colorado Springs, Colorado, United States (enrolling)
- TG Therapeutics Investigational Trial Site — Clearwater, Florida, United States (enrolling)
Full record on ClinicalTrials.gov
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