TG Therapeutics, Inc.
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.
Inclusion Criteria: * Diagnosis of RMS (2017 Revised McDonald criteria). * Participants must meet one of the following prior treatment definitions: 1. Participants naïve to treatment. 2. Participants previously treated with a disease modifying therapy (DMT) who have discontinued treatment prior to consent and meet the washout requirements. * Expanded Disability Status Scale (EDSS) score ≤ 5.5 at screening. * Neurologically stable for \> 30 days prior to first dose of ublituximab. * Female participants of childbearing potential must consent to use a medically acceptable method of contrace…
Administered as an intravenous (IV) infusion.
IV infusion