The primary purpose of this study is to evaluate the efficacy of ublituximab in adult participants with MG responding to treatment with efgartigimod.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
120
Administered as an IV infusion.
Administered as an IV infusion.
TG Therapeutics Investigational Trial Site
Colorado Springs, Colorado, United States
RECRUITINGTG Therapeutics Investigational Trial Site
Colorado Springs, Colorado, United States
RECRUITINGTG Therapeutics Investigational Trial Site
Clearwater, Florida, United States
Time to Onset of a Clinical Worsening Event
Time frame: Up to Week 24
Number of Participants with Treatment-Emergent Adverse Events (TEAEs)
Time frame: Up to Week 72
Maximum Plasma Concentration (Cmax) of Ublituximab
Time frame: Up to Week 72
Proportion of Participants with Cluster of Differentiation 19 + (CD19+) B-cell Counts
Time frame: Up to Week 72
Change From Baseline in Myasthenia Gravis-Activities of Daily Living (MG-ADL) Total Score in RCP
The MG-ADL scale focuses on relevant symptoms and functional performance of activities of daily living in participants with MG. The total score varies between 0-24, with higher score indicating more severe disease.
Time frame: Baseline, Week 24
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TG Therapeutics Investigational Trial Site
Farmington Hills, Michigan, United States
RECRUITINGTG Therapeutics Investigational Trial Site
New Bern, North Carolina, United States
RECRUITINGTG Therapeutics Investigational Trial Site
Greenville, South Carolina, United States
RECRUITING