The purpose of this study is to assess the pharmacokinetics of ublituximab when administered subcutaneously (SC) compared to intravenous (IV) administration in participants with RMS.
This is a Phase 3, open label, parallel-group, multicenter study in participants with RMS.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
360
Administered as an IV infusion.
Administered as an SC injection.
Area Under the Curve From Week 0 to Week 24 (AUC0-W24) of Ublituximab
Time frame: Up to Week 24
Minimum Plasma Concentration (Cmin) of Ublituximab
Time frame: Up to Week 24
Average Concentration at Steady State (Cavg,ss) of Ublituximab
Time frame: Up to Week 120
Maximum Plasma Concentration (Cmax) of Ublituximab
Time frame: Up to Week 120
Time to Maximum Plasma Concentration (Tmax) of Ublituximab
Time frame: Up to Week 120
Last Observed Concentration (Clast) of Ublituximab
Time frame: Up to Week 120
Area Under the Curve From Week 0 to Week 120 (AUC0-120) of Ublituximab
Time frame: Up to Week 120
Concentration From Time 0 to Time of Last Concentration (AUClast) of Ublituximab
Time frame: Up to Week 120
Time of Last Concentration (Tlast) of Ublituximab
Time frame: Up to Week 120
Participants B Cell Counts
Time frame: Up to Week 120
Incidence of Treatment Emergent Adverse Events (TEAEs)
Time frame: Up to Week 120
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TG Therapeutics Investigational Trial Site
Banja Luka, Bosnia and Herzegovina
TG Therapeutics Investigational Trial Site
Bihać, Bosnia and Herzegovina
TG Therapeutics Investigational Trial Site
Mostar, Bosnia and Herzegovina
TG Therapeutics Investigational Trial Site
Saravejo, Bosnia and Herzegovina
TG Therapeutics Investigational Trial Site
Tulza, Bosnia and Herzegovina
TG Therapeutics Investigational Trial Site
Pleven, Bulgaria
TG Therapeutics Investigational Trial Site
Plovdiv, Bulgaria
TG Therapeutics Investigational Trial Site
Sofia, Bulgaria
TG Therapeutics Investigational Trial Site
Sofia, Bulgaria
TG Therapeutics Investigational Trial Site
Veliko Tarnovo, Bulgaria
...and 38 more locations
Total Number of Gadolinium (Gd) enhancing T1 Lesions Per Magnetic Resonance Imaging (MRI) Scan
Time frame: Up to Week 96
Total Number of New or Enlarging T2 lesions Per MRI Scan
Time frame: Up to Week 96