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Clinical Trials in the USA / NCT07673744
Recruiting Phase 2

A Study to Evaluate the Efficacy and Safety of Maintenance Ublituximab Following Induction With Efgartigimod Administration in Participants With Myasthenia Gravis (MG)

NCT07673744 · tracked via the Priya Life Science USA tracker
Sponsor
TG Therapeutics, Inc.
Phase
Phase 2
Started
2026-07-30
Last updated
2026-08-21

Condition(s) studied

Myasthenia Gravis

Investigational drug(s) / intervention(s)

UblituximabPlacebo

Ublituximab: Administered as an IV infusion.

Placebo: Administered as an IV infusion.

Study 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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (5)

FacilityCityRegionStatus
TG Therapeutics Investigational Trial Site Colorado Springs Colorado Recruiting
TG Therapeutics Investigational Trial Site Colorado Springs Colorado Recruiting
TG Therapeutics Investigational Trial Site Clearwater Florida Recruiting
TG Therapeutics Investigational Trial Site Farmington Hills Michigan Recruiting
TG Therapeutics Investigational Trial Site New Bern North Carolina Recruiting

More TG Therapeutics, Inc. trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07673744 on ClinicalTrials.gov ↗ ← All trials in the USA