NCT07673744 A Study to Evaluate the Efficacy and Safety of Maintenance Ublituximab Following Induction With Efgartigimod Administration in Participants With Myasthenia Gravis (MG)
| NCT ID | NCT07673744 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | TG Therapeutics, Inc. |
| Condition | Myasthenia Gravis |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2026-07-30 |
| Primary Completion | 2028-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 120 participants in total. It began in 2026-07-30 with a primary completion date of 2028-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07673744 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Myasthenia Gravis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07673744 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07673744 currently recruiting?
Yes, NCT07673744 is actively recruiting participants. Contact the research team at clinicalsupport@tgtxinc.com for enrollment information.
Where is the NCT07673744 trial being conducted?
This trial is being conducted at Colorado Springs, United States, Colorado Springs, United States, Clearwater, United States, Farmington Hills, United States and 1 additional location.
Who is sponsoring the NCT07673744 clinical trial?
NCT07673744 is sponsored by TG Therapeutics, Inc.. The trial plans to enroll 120 participants.