A Study to Evaluate the Efficacy and Safety of Maintenance Ublituximab Following Induction With Efgartigimod Administration in Participants With Myasthenia Gravis (MG)
TG Therapeutics, Inc. · NCT07673744
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 18+ · All sexes
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Phase 2
- Target enrollment
- 120
- US sites recruiting
- 6
- Study start
- October 1, 2026
- Record last updated
- September 22, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
The primary purpose of this study is to evaluate the efficacy of ublituximab in adult participants with MG responding to treatment with efgartigimod.
Being studied: Ublituximab; Placebo
Conditions: Myasthenia Gravis
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Recruiting US locations
TG Therapeutics Investigational Trial Site
Colorado Springs, CO 80919
TG Therapeutics Investigational Trial Site
Colorado Springs, CO 80920
TG Therapeutics Investigational Trial Site
Clearwater, FL 33761
TG Therapeutics Investigational Trial Site
Farmington Hills, MI 48334
TG Therapeutics Investigational Trial Site
New Bern, NC 28562
TG Therapeutics Investigational Trial Site
Greenville, SC 29605
Study contacts (from the official record)
- TG Therapeutics Clinical Support Team · 1-877-575-8489 · clinicalsupport@tgtxinc.com