Study to Evaluate Safety, Efficacy and Pharmacokinetics (PK) of a Modified Regimen of Ublituximab

Summary

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.

Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov

Conditions studied

• Relapsing Multiple Sclerosis

Eligibility basics and study details

Study type

Interventional

Phase

Phase 3

Ages

18 to 65 years

Sex

All

Healthy volunteers

Not accepted

Sponsor

TG Therapeutics, Inc.

Last updated on ClinicalTrials.gov

September 21, 2026

These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.

US recruiting sites