Suspended

Long-term Safety and Efficacy of Ublituximab in Relapsing Multiple Sclerosis

Study Aim

This study aims to evaluate the long-term safety and effectiveness of Ublituximab treatment in individuals with relapsing Multiple Sclerosis, primarily focusing on reducing the annual relapse rate.

What is being tested

Ublituximab

Biological

Who is being recruted

Over 18 Years

+13 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 3

Interventional

Study Start: November 2019

See protocol details

Summary

Principal SponsorTG Therapeutics, Inc.

Last updated: February 4, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: November 18, 2019

Actual date on which the first participant was enrolled.

This study focuses on a drug called ublituximab, which is being tested for its long-term safety and effectiveness in people with relapsing multiple sclerosis (RMS). The goal is to understand how well this drug works over an extended period, and if it can help manage the condition better. The study is open to participants who have previously completed certain other clinical trials related to RMS. During this study, participants will receive ublituximab treatment. The main outcome being measured is the Annualized Relapse Rate (ARR), which is the number of relapses a participant experiences per year. This is calculated by dividing the total number of relapses by the total time spent on the study treatment. The study aims to see if ublituximab can reduce the number of relapses over time.

Official TitleAn Open Label Extension Study of Ublituximab in Subjects With Relapsing Multiple Sclerosis

NCT04130997

Principal SponsorTG Therapeutics, Inc.

Last updated: February 4, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

1100 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

4 inclusion criteria required to participate

Female participants of child-bearing potential, and male partners must consent to use a medically acceptable method of contraception from consent, throughout the study period, and for 20 weeks after the last dose of ublituximab

Complete the 96-week double-blind TG1101-RMS301 (NCT03277261) or TG1101-RMS302 (NCT03277248) study or complete the final Week 208 visit of the TG1101-RMS201E (NCT03381170) study

Investigator believes may benefit from treatment with ublituximab

Are able and willing to provide written informed consent (e.g., before the first infusion) and to comply with the study protocol

9 exclusion criteria prevent from participating

Any significant or uncontrolled medical condition or treatment-emergent, clinically significant laboratory abnormality such as: • Absolute neutrophil count < 1.5 x 10e3/µL • Hematocrit < 24% • Platelet count < 150,000 cell/mm^3 • Hypogammaglobulinemia immunoglobulin G (IgG) < 4.0g/L

Active infection

Presence of malignancy, except for surgically excised basal or squamous cell skin lesions

Participants who have had a confirmed multiple sclerosis (MS) relapse within the past 30 days prior to Week 1 Day 1 (W1D1). Following a relapse, participants must be neurologically stable for at least 30 days prior to screening or W1D1 of the OLE

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

RMS301/RMS302: All participants transferring from RMS301/RMS302 who sign consent for this study will receive an initial 4-hour infusion of 150 mg ublituximab on Week 1 (Day 1) followed by a 1-hour infusion of 450 mg ublituximab 14 days later Week 3 (Day 15). Subsequent infusions of ublituximab will be administered at 450 mg for 1-hour every 24 weeks from Weeks 24 to 312. RMS201E: All participants transferring from RMS201E who sign consent for this study will receive a 1-hour infusion of 450 mg ublituximab on Week 1 (Day 1) and subsequent infusions of ublituximab will be administered at 450 mg for 1-hour every 24 weeks from Weeks 24 to 312. For all participants (RMS301/RMS302/RMS201E), infusion treatment will continue for 312 weeks, or until physician or participant decision to withdraw from the study.

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 86 locations

Suspended

TG Therapeutics Investigational Trial Site

Pasadena, United StatesOpen TG Therapeutics Investigational Trial Site in Google Maps

Suspended

TG Therapeutics Investigational Trial Site

Denver, United States

Suspended

TG Therapeutics Investigational Trial Site

Miami, United States

Suspended

TG Therapeutics Investigational Trial Site

Tampa, United States

Suspended86 Study Centers