The primary purpose of this phase 3b study is to assess the efficacy of a modified regimen of ublituximab in participants with relapsing multiple sclerosis (RMS) as measured by T1 Gadolinium (Gd)-enhancing lesions in Part A; PK in Part B along with efficacy of ublituximab as measured by T1 Gd-enhancing lesions in participants who had a suboptimal experience on prior anti-CD20 therapy in Part C. The study consists of 3 parts: Part A is single-armed and open-label, Part B is randomized, double-blind, placebo-controlled, and Part C is single-armed and open-label.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
800
Administered as an intravenous (IV) infusion.
IV infusion
TG Therapeutics Investigational Trial Site
Birmingham, Alabama, United States
RECRUITINGTG Therapeutics Investigational Trial Site
Cullman, Alabama, United States
RECRUITINGTG Therapeutics Investigational Trial Site
Orange, California, United States
RECRUITINGTG Investigational Site
Fort Collins, Colorado, United States
Part A and Part C: Percentage of Participants With no Change or Reduction in Number of T1 Gd-Enhancing Lesions From Baseline to Week 48
The Gd-enhancing T1 lesions will be evaluated using magnetic resonance imaging (MRI) technique.
Time frame: Baseline up to Week 48
Part B: Area Under the Curve Over the First 16 Weeks (AUC0-W16) of Ublituximab
Time frame: Predose and at multiple timepoints up to Week 16
Parts A: Percentage of Participants Free of T1 Gd-Enhancing Lesions
The Gd-enhancing T1 lesions will be evaluated using MRI technique.
Time frame: Week 48
Parts A and B: Percentage of Participants Experiencing Infusion Related Reactions (IRRs)
IRRs are defined as infusion related adverse events (AEs) that occur within one day of an infusion and resolve within 7 days. IRRs will be reported by investigator.
Time frame: Up to Week 48
Parts A: Change From Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM-9) Scores
The TSQM-9 is a 9-item questionnaire with 3 domains: Satisfaction, convenience, and effectiveness.
Time frame: Part A: Baseline, Week 24 and Week 48
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TG Therapeutics Investigational Trial Site
Washington D.C., District of Columbia, United States
RECRUITINGTG Therapeutics Investigational Trial Site
Tampa, Florida, United States
RECRUITINGTG Therapeutics Investigational Trial Site
Atlanta, Georgia, United States
RECRUITINGTG Therapeutics Investigational Trial Site
Atlanta, Georgia, United States
RECRUITINGTG Therapeutics Investigational Trial Site
Savannah, Georgia, United States
RECRUITINGTG Therapeutics Investigational Trial Site
Chicago, Illinois, United States
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