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Ublituximab shows promise for Long-Term MS control in large extension trial

NCT ID NCT04130997

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 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Aug 21, 2026 · Updated 2 times

Summary

This study is a long-term follow-up for people with relapsing multiple sclerosis who previously completed a ublituximab trial. It aims to see if the drug remains safe and effective over time. About 1100 participants will receive ublituximab infusions, and researchers will track relapse rates and side effects.

What this could mean

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

Active substance
ublituximab (a monoclonal antibody targeting CD20)
What this could lead to
If successful, this study could confirm ublituximab as a safe and effective long-term treatment to reduce relapses in people with relapsing multiple sclerosis.
What could go wrong
This is an extension study, so participants already know they tolerate ublituximab. However, long-term risks or reduced effectiveness over time are still possible. The study is not designed to prove a cure.

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 1,100 people

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

Started

Nov 2019

Expected to finish

May 2032

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 years and older

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: Participants must meet the following criteria: 1. 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 2. Investigator believes may benefit from treatment with ublituximab 3. Are able and willing to provide written informed consent (e.g., before the first infusion) and to comply with the study protocol 4. 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 Exclusion Criteria: Participants who meet any of the following exclusion criteria are not to be enrolled to this study: 1. Any significant or uncontrolled medical condition or treatment-emergent, clinically significant laboratory abnormality such as: 1. Absolute neutrophil count \< 1.5 x 10e3/µL 2. Hematocrit \< 24% 3. Platelet count \< 150,000 cell/mm\^3 4. Hypogammaglobulinemia immunoglobulin G (IgG) \< 4.0g/L 2. Active infection 3. Ongoing pregnancy (female participants) 4. Participants who discontinued ublituximab treatment or withdrew consent from the TG1101-RMS301 or TG1101-RMS302 study during the 96-week evaluation period or prior to completing the final Week 208 visit of the TG1101-RMS201E study 5. Participants who have started any disease modifying therapy (DMT), stem cell transplantation, or participation in any other interventional clinical trial after completion of the 96-week visit in the TG1101-RMS301, TG1101-RMS302, or after completing the final Week 208 visit of the TG1101-RMS201E study 6. 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 7. Participants with unstable disease activity 8. Presence of malignancy, except for surgically excised basal or squamous cell skin lesions 9. Vaccination with live virus within 2 months of randomization

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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 (RMS)

Contacts and locations

Locations

  • TG Investigational Trial Site

    Zagreb, 10000, Croatia

  • TG Therapeutics Investigational Trial Site

    Pasadena, California, 91105, United States

  • TG Therapeutics Investigational Trial Site

    Denver, Colorado, 80045, United States

  • TG Therapeutics Investigational Trial Site

    Miami, Florida, 33136, United States

  • TG Therapeutics Investigational Trial Site

    Tampa, Florida, 33612, United States

  • TG Therapeutics Investigational Trial Site

    Northbrook, Illinois, 60062, United States

  • TG Therapeutics Investigational Trial Site

    Kansas City, Kansas, 66160, United States

  • TG Therapeutics Investigational Trial Site

    Detroit, Michigan, 48201, United States

  • TG Therapeutics Investigational Trial Site

    Las Vegas, Nevada, 89106, United States

  • TG Therapeutics Investigational Trial Site

    Teaneck, New Jersey, 07666, United States

  • TG Therapeutics Investigational Trial Site

    Albuquerque, New Mexico, 87131, United States

  • TG Therapeutics Investigational Trial Site

    Amherst, New York, 14266, United States

  • TG Therapeutics Investigational Trial Site

    Columbus, Ohio, 43214, United States

  • TG Therapeutics Investigational Trial Site

    Westerville, Ohio, 43081, United States

  • TG Therapeutics Investigational Trial Site

    Knoxville, Tennessee, 37922, United States

  • TG Therapeutics Investigational Trial Site

    Dallas, Texas, 75246, United States

  • TG Therapeutics Investigational Trial Site

    Frisco, Texas, 75034, United States

  • TG Therapeutics Investigational Trial Site

    Round Rock, Texas, 78681, United States

  • TG Therapeutics Investigational Trial Site

    San Antonio, Texas, 78258, United States

  • TG Therapeutics Investigational Trial Site

    Seattle, Washington, 98109, United States

  • TG Therapeutics Investigational Trial Site

    Grodno, 230017, Belarus

  • TG Therapeutics Investigational Trial Site

    Grodno, 320017, Belarus

  • TG Therapeutics Investigational Trial Site

    Minsk, 220114, Belarus

  • TG Therapeutics Investigational Trial Site

    Minsk, 220116, Belarus

  • TG Therapeutics Investigational Trial Site

    Minsk, 220226, Belarus

  • TG Therapeutics Investigational Trial Site

    Osijek, 31000, Croatia

  • TG Therapeutics Investigational Trial Site

    Varaždin, 42000, Croatia

  • TG Therapeutics Investigational Trial Site

    Tbilisi, 00112, Georgia

  • TG Therapeutics Investigational Trial Site

    Tbilisi, 00114, Georgia

  • TG Therapeutics Investigational Trial Site

    Tbilisi, 00159, Georgia

  • TG Therapeutics Investigational Trial Site

    Tbilisi, 00160, Georgia

  • TG Therapeutics Investigational Trial Site

    Tbilisi, 00172, Georgia

  • TG Therapeutics Investigational Trial Site

    Tbilisi, 00179, Georgia

  • TG Therapeutics Investigational Trial Site

    Katowice, 40-555, Poland

  • TG Therapeutics Investigational Trial Site

    Katowice, 40-568, Poland

  • TG Therapeutics Investigational Trial Site

    Katowice, 40-684, Poland

  • TG Therapeutics Investigational Trial Site

    Krakow, 31-505, Poland

  • TG Therapeutics Investigational Trial Site

    Lodz, 41-800, Poland

  • TG Therapeutics Investigational Trial Site

    Olsztyn, 10-561, Poland

  • TG Therapeutics Investigational Trial Site

    Poznan, 61-583, Poland

  • TG Therapeutics Investigational Trial Site

    Warsaw, 04-141, Poland

  • TG Therapeutics Investigational Trial Site

    Zabrze, 04-749, Poland

  • TG Therapeutics Investigational Trial Site

    Arkhangelsk, 163045, Russia

  • TG Therapeutics Investigational Trial Site

    Barnaul, 656045, Russia

  • TG Therapeutics Investigational Trial Site

    Bryansk, 241033, Russia

  • TG Therapeutics Investigational Trial Site

    Chelyabinsk, 454021, Russia

  • TG Therapeutics Investigational Trial Site

    Kemerovo, 650066, Russia

  • TG Therapeutics Investigational Trial Site

    Krasnoyarsk, 660037, Russia

  • TG Therapeutics Investigational Trial Site

    Kursk, 305007, Russia

  • TG Therapeutics Investigational Trial Site

    Moscow, 125367, Russia

  • TG Therapeutics Investigational Trial Site

    Moscow, 127015, Russia

  • TG Therapeutics Investigational Trial Site

    Nizhny Novgorod, 603155, Russia

  • TG Therapeutics Investigational Trial Site

    Novosibirsk, 630007, Russia

  • TG Therapeutics Investigational Trial Site

    Novosibirsk, 630087, Russia

  • TG Therapeutics Investigational Trial Site

    Pyatigorsk, 357538, Russia

  • TG Therapeutics Investigational Trial Site

    Saint Petersburg, 197002, Russia

  • TG Therapeutics Investigational Trial Site

    Saint Petersburg, 197110, Russia

  • TG Therapeutics Investigational Trial Site

    Saint Petersburg, 197376, Russia

  • TG Therapeutics Investigational Trial Site

    Saransk, 430032, Russia

  • TG Therapeutics Investigational Trial Site

    Smolensk, 214018, Russia

  • TG Therapeutics Investigational Trial Site

    Tomsk, 634050, Russia

  • TG Therapeutics Investigational Trial Site

    Tyumen, 625000, Russia

  • TG Therapeutics Investigational Trial Site

    Ufa, 450005, Russia

  • TG Therapeutics Investigational Trial Site

    Yekaterinburg, 620102, Russia

  • TG Therapeutics Investigational Trial Site

    Belgrade, 11000, Serbia

  • TG Therapeutics Investigational Trial Site

    Kragujevac, 34000, Serbia

  • TG Therapeutics Investigational Trial Site

    Cherkasy, 18009, Ukraine

  • TG Therapeutics Investigational Trial Site

    Chernihiv, 14001, Ukraine

  • TG Therapeutics Investigational Trial Site

    Chernihiv, 14029, Ukraine

  • TG Therapeutics Investigational Trial Site

    Chernivtsi, 58002, Ukraine

  • TG Therapeutics Investigational Trial Site

    Ivano-Frankivsk, 76008, Ukraine

  • TG Therapeutics Investigational Trial Site

    Kharkiv, 61058, Ukraine

  • TG Therapeutics Investigational Trial Site

    Kharkiv, 61103, Ukraine

  • TG Therapeutics Investigational Trial Site

    Kharkiv, 61176, Ukraine

  • TG Therapeutics Investigational Trial Site

    Kyiv, 03037, Ukraine

  • TG Therapeutics Investigational Trial Site

    Kyiv, 03115, Ukraine

  • TG Therapeutics Investigational Trial Site

    Lviv, 79000, Ukraine

  • TG Therapeutics Investigational Trial Site

    Lviv, 79010, Ukraine

  • TG Therapeutics Investigational Trial Site

    Odesa, 65009, Ukraine

  • TG Therapeutics Investigational Trial Site

    Poltava, 36011, Ukraine

  • TG Therapeutics Investigational Trial Site

    Ternopil, 46027, Ukraine

  • TG Therapeutics Investigational Trial Site

    Uzhhorod, 88018, Ukraine

  • TG Therapeutics Investigational Trial Site

    Vinnytsia, 21005, Ukraine

  • TG Therapeutics Investigational Trial Site

    Zaporizhia, 69065, Ukraine

  • TG Therapeutics Investigational Trial Site

    Zaporizhia, 96900, Ukraine

  • TG Therapeutics Investigational Trial Site

    Zhytomyr, 10002, Ukraine

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