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New dosing strategy for MS drug ublituximab under study in 800-Patient trial

NCT ID NCT05877963

Disease control Sponsor: TG Therapeutics, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Aug 28, 2026 · Updated 5 times

Summary

This Phase 3 trial is testing a modified dosing schedule of ublituximab (BRIUMVI) in 800 people with relapsing multiple sclerosis. The study has three parts: one open-label part to see if the new regimen reduces brain lesions, a placebo-controlled part to measure drug levels, and another open-label part for those who had a poor response to prior anti-CD20 therapy. The goal is to find a safer or more effective way to control MS relapses.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ublituximab (BRIUMVI)
What this could lead to
If successful, this could offer a more effective or convenient dosing schedule for ublituximab to control relapsing multiple sclerosis.
What could go wrong
This is a Phase 3 study, but results may not confirm benefit over existing treatments. Infusion-related reactions and other side effects are possible.
Why investors are watching

TG Therapeutics is running a phase 3 trial of ublituximab, its drug for relapsing multiple sclerosis, in 800 participants. The trial tests a modified dosing schedule and also looks at patients who did not respond well to a prior anti-CD20 therapy. For a small company, this readout matters because ublituximab is a core product, and the results will show whether the drug works in a broader patient group.

If it works: A positive result could support a wider use of ublituximab in multiple sclerosis, potentially expanding its market. It may also strengthen the company's position with regulators and doctors.

If it fails: A failure or delay could hurt the drug's prospects and the company's value, since trials often do not meet their goals. The company's size means it has fewer other products to fall back on.

AI-written from the trial record. Speculative, and not investment advice.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 800 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2023

Expected to finish

Jan 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 contraception from consent, throughout the study period, and for 6 months after the last dose of ublituximab. * Part C: participants currently treated with an anti-CD20 agent for at least 6 months and meet the washout requirements prior to W1D1. * Part C: Discontinuation of current anti-CD20 must be due to suboptimal experience Exclusion Criteria: * History of any serious 3 Infusion Related Reaction (IRR) on prior anti-CD20 therapy. * Primary-progressive multiple sclerosis (PPMS) or inactive Secondary Progressive MS (SPMS). * Active chronic (or stable but treated with immune therapy) disease of the immune system other than MS (e.g., rheumatoid arthritis, scleroderma, Sjögren's syndrome, Crohn's disease, ulcerative colitis, etc.) or immunodeficiency syndrome (hereditary immune deficiency, drug-induced immune deficiency, etc.). * Current evidence or known history of clinically significant infection, including: chronic, recurrent, or ongoing active viral, bacterial, or fungal infectious disease requiring long term systemic treatment such as, but not limited to chronic urinary tract infection, chronic pulmonary infection with bronchiectasis, tuberculosis, or active hepatitis C virus (HCV). * Previous serious opportunistic or atypical infection. * Evidence of chronic active or history of hepatitis B virus (HBV) infection as evidenced by a detectable hepatitis B surface antigen (HBsAg), or positive hepatitis B core antibody (HBcAb), or chronic hepatitis C infection. Participants with positive hepatitis C virus antibody (HCV Ab) are eligible only if polymerase chain reaction (PCR) is negative for HCV ribonucleic acid (RNA). * History or evidence (clinical, radiological, or biomarker) of suspected or confirmed progressive multifocal leukoencephalopathy (PML). * Receipt of any live or live-attenuated vaccines (including vaccines for varicella-zoster virus or measles) within 4 weeks prior to first study drug administration. * Participants requiring treatment with intravenous immune globulin (IVIG) for decreased immunoglobulins within the 12 months prior to W1D1. * Any active malignancies other than adequately treated basal, squamous cell or in situ carcinoma. * Participants who have ever received ublituximab, alemtuzumab, cyclophosphamide, mitoxantrone, cladribine, or daclizumab (including for non-MS indications). Note: Other Inclusion/Exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

relapsing-remitting multiple sclerosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Relapsing multiple sclerosis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    49 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • TG Investigational Site

    RECRUITING

    Fort Collins, Colorado, 80528, United States

  • TG Investigational Site

    RECRUITING

    Farmington, Michigan, 48334, United States

  • TG Therapeutics Investigational Trial Site

    RECRUITING

    Birmingham, Alabama, 35209, United States

  • TG Therapeutics Investigational Trial Site

    RECRUITING

    Cullman, Alabama, 35058, United States

  • TG Therapeutics Investigational Trial Site

    RECRUITING

    Orange, California, 92697, United States

  • TG Therapeutics Investigational Trial Site

    RECRUITING

    Washington D.C., District of Columbia, 20007, United States

  • TG Therapeutics Investigational Trial Site

    RECRUITING

    Tampa, Florida, 33612, United States

  • TG Therapeutics Investigational Trial Site

    RECRUITING

    Atlanta, Georgia, 30309, United States

  • TG Therapeutics Investigational Trial Site

    RECRUITING

    Atlanta, Georgia, 30322, United States

  • TG Therapeutics Investigational Trial Site

    RECRUITING

    Savannah, Georgia, 31406, United States

  • TG Therapeutics Investigational Trial Site

    RECRUITING

    Chicago, Illinois, 60612, United States

  • TG Therapeutics Investigational Trial Site

    RECRUITING

    Indianapolis, Indiana, 46256, United States

  • TG Therapeutics Investigational Trial Site

    RECRUITING

    Iowa City, Iowa, 52242, United States

  • TG Therapeutics Investigational Trial Site

    RECRUITING

    Overland Park, Kansas, 66205, United States

  • TG Therapeutics Investigational Trial Site

    COMPLETED

    Overland Park, Kansas, 66212, United States

  • TG Therapeutics Investigational Trial Site

    RECRUITING

    Lutherville, Maryland, 21093, United States

  • TG Therapeutics Investigational Trial Site

    RECRUITING

    Boston, Massachusetts, 00002, United States

  • TG Therapeutics Investigational Trial Site

    RECRUITING

    Boston, Massachusetts, 70809, United States

  • TG Therapeutics Investigational Trial Site

    RECRUITING

    Foxborough, Massachusetts, 02035, United States

  • TG Therapeutics Investigational Trial Site

    RECRUITING

    North Worcester, Massachusetts, 01655, United States

  • TG Therapeutics Investigational Trial Site

    RECRUITING

    Wellesley, Massachusetts, 02481, United States

  • TG Therapeutics Investigational Trial Site

    RECRUITING

    Golden Valley, Minnesota, 55422, United States

  • TG Therapeutics Investigational Trial Site

    RECRUITING

    Plymouth, Minnesota, 55446, United States

  • TG Therapeutics Investigational Trial Site

    RECRUITING

    St Louis, Missouri, 63131, United States

  • TG Therapeutics Investigational Trial Site

    RECRUITING

    New York, New York, 10025, United States

  • TG Therapeutics Investigational Trial Site

    RECRUITING

    New York, New York, 11021, United States

  • TG Therapeutics Investigational Trial Site

    RECRUITING

    Raleigh, North Carolina, 27607, United States

  • TG Therapeutics Investigational Trial Site

    RECRUITING

    Cincinnati, Ohio, 45212, United States

  • TG Therapeutics Investigational Trial Site

    RECRUITING

    Cleveland, Ohio, 44195, United States

  • TG Therapeutics Investigational Trial Site

    RECRUITING

    Dayton, Ohio, 45417, United States

  • TG Therapeutics Investigational Trial Site

    RECRUITING

    Oklahoma City, Oklahoma, 73104, United States

  • TG Therapeutics Investigational Trial Site

    RECRUITING

    Greenville, South Carolina, 29605, United States

  • TG Therapeutics Investigational Trial Site

    RECRUITING

    Knoxville, Tennessee, 37922, United States

  • TG Therapeutics Investigational Trial Site

    COMPLETED

    Houston, Texas, 77030, United States

  • TG Therapeutics Investigational Trial Site

    RECRUITING

    Salt Lake City, Utah, 84103, United States

  • TG Therapeutics Investigational Trial Site

    RECRUITING

    Vienna, Virginia, 22182, United States

  • TG Therapeutics Investigational Trial Site

    RECRUITING

    Kirkland, Washington, 98034, United States

  • TG Therapeutics Investigational Trial Site

    RECRUITING

    Seattle, Washington, 98109, United States

  • TG Therapeutics Investigational Trial Site

    RECRUITING

    Spokane, Washington, 99208, United States

  • TG Therapeutics Investigational Trial Site

    RECRUITING

    Milwaukee, Wisconsin, 53226, United States

  • TG Therapeutics Investigational Trial Site

    RECRUITING

    Bydgoszcz, 85-796, Poland

  • TG Therapeutics Investigational Trial Site

    RECRUITING

    Katowice, 40-555, Poland

  • TG Therapeutics Investigational Trial Site

    RECRUITING

    Kielce, 25-726, Poland

  • TG Therapeutics Investigational Trial Site

    RECRUITING

    Krakow, 31-826, Poland

  • TG Therapeutics Investigational Trial Site

    RECRUITING

    Lodz, 90-324, Poland

  • TG Therapeutics Investigational Trial Site

    RECRUITING

    Olsztyn, 10-561, Poland

  • TG Therapeutics Investigational Trial Site

    RECRUITING

    Poznan, 61-583, Poland

  • TG Therapeutics Investigational Trial Site

    RECRUITING

    Warsaw, 04-141, Poland

  • TG Therapeutics Investigational Trial Site

    RECRUITING

    Zabrze, Poland

  • TG Therapeutics Investigational Trial Site

    RECRUITING

    Żory, 44-240, Poland

  • TG Therapeutics Investigational Trial SiteCharlotte

    RECRUITING

    Charlotte, North Carolina, 28204, United States

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