Relapsing Multiple Sclerosis (RMS)Phase 3NCT04130997

An Extension Study of Ublituximab in Participants With Relapsing Multiple Sclerosis

A Phase 3 study testing Ublituximab in people with Relapsing Multiple Sclerosis (RMS), run by TG Therapeutics, Inc. at 86 sites in 8 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

The purpose of this study is to evaluate long-term safety and efficacy of ublituximab therapy in participants with relapsing multiple sclerosis (RMS). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Relapsing Multiple Sclerosis (RMS)
What is being tested?: Ublituximab
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,100 participants
Where: 86 sitesin 8 countries
Study dates: 18 Nov 2019to 31 May 2032
Phase: Phase 3
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Participants must meet the following criteria:
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
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

Who cannot join

Participants who meet any of the following exclusion criteria are not to be enrolled to this study:
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

Show all 14Show fewer

Active infection
Ongoing pregnancy (female participants)
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
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
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
Participants with unstable disease activity
Presence of malignancy, except for surgically excised basal or squamous cell skin lesions
Vaccination with live virus within 2 months of randomization

Trial locations and contacts

86 sites in 8 countries.

Country

City, postcode or hospital

86 sites in 8 countries

Russia22 sites

TG Therapeutics Investigational Trial Site
Arkhangelsk, 163045
TG Therapeutics Investigational Trial Site
Barnaul, 656045
TG Therapeutics Investigational Trial Site
Bryansk, 241033
TG Therapeutics Investigational Trial Site
Chelyabinsk, 454021
TG Therapeutics Investigational Trial Site
Kemerovo, 650066
TG Therapeutics Investigational Trial Site
Krasnoyarsk, 660037
TG Therapeutics Investigational Trial Site
Kursk, 305007
TG Therapeutics Investigational Trial Site
Moscow, 125367
TG Therapeutics Investigational Trial Site
Moscow, 127015
TG Therapeutics Investigational Trial Site
Nizhny Novgorod, 603155
TG Therapeutics Investigational Trial Site
Novosibirsk, 630007
TG Therapeutics Investigational Trial Site
Novosibirsk, 630087
TG Therapeutics Investigational Trial Site
Pyatigorsk, 357538
TG Therapeutics Investigational Trial Site
Saint Petersburg, 197002
TG Therapeutics Investigational Trial Site
Saint Petersburg, 197110
TG Therapeutics Investigational Trial Site
Saint Petersburg, 197376
TG Therapeutics Investigational Trial Site
Saransk, 430032
TG Therapeutics Investigational Trial Site
Smolensk, 214018
TG Therapeutics Investigational Trial Site
Tomsk, 634050
TG Therapeutics Investigational Trial Site
Tyumen, 625000
TG Therapeutics Investigational Trial Site
Ufa, 450005
TG Therapeutics Investigational Trial Site
Yekaterinburg, 620102

Other trials in Russia

Ukraine20 sites

TG Therapeutics Investigational Trial Site
Cherkasy, 18009
TG Therapeutics Investigational Trial Site
Chernihiv, 14001
TG Therapeutics Investigational Trial Site
Chernihiv, 14029
TG Therapeutics Investigational Trial Site
Chernivtsi, 58002
TG Therapeutics Investigational Trial Site
Ivano-Frankivsk, 76008
TG Therapeutics Investigational Trial Site
Kharkiv, 61058
TG Therapeutics Investigational Trial Site
Kharkiv, 61103
TG Therapeutics Investigational Trial Site
Kharkiv, 61176
TG Therapeutics Investigational Trial Site
Kyiv, 03037
TG Therapeutics Investigational Trial Site
Kyiv, 03115
TG Therapeutics Investigational Trial Site
Lviv, 79000
TG Therapeutics Investigational Trial Site
Lviv, 79010
TG Therapeutics Investigational Trial Site
Odesa, 65009
TG Therapeutics Investigational Trial Site
Poltava, 36011
TG Therapeutics Investigational Trial Site
Ternopil, 46027
TG Therapeutics Investigational Trial Site
Uzhhorod, 88018
TG Therapeutics Investigational Trial Site
Vinnytsia, 21005
TG Therapeutics Investigational Trial Site
Zaporizhia, 69065
TG Therapeutics Investigational Trial Site
Zaporizhia, 96900
TG Therapeutics Investigational Trial Site
Zhytomyr, 10002

Other trials in Ukraine

United States19 sites

TG Therapeutics Investigational Trial Site
Albuquerque, New Mexico, 87131
TG Therapeutics Investigational Trial Site
Amherst, New York, 14266
TG Therapeutics Investigational Trial Site
Columbus, Ohio, 43214
TG Therapeutics Investigational Trial Site
Dallas, Texas, 75246
TG Therapeutics Investigational Trial Site
Denver, Colorado, 80045
TG Therapeutics Investigational Trial Site
Detroit, Michigan, 48201
TG Therapeutics Investigational Trial Site
Frisco, Texas, 75034
TG Therapeutics Investigational Trial Site
Kansas City, Kansas, 66160
TG Therapeutics Investigational Trial Site
Knoxville, Tennessee, 37922
TG Therapeutics Investigational Trial Site
Las Vegas, Nevada, 89106
TG Therapeutics Investigational Trial Site
Miami, Florida, 33136
TG Therapeutics Investigational Trial Site
Northbrook, Illinois, 60062
TG Therapeutics Investigational Trial Site
Pasadena, California, 91105
TG Therapeutics Investigational Trial Site
Round Rock, Texas, 78681
TG Therapeutics Investigational Trial Site
San Antonio, Texas, 78258
TG Therapeutics Investigational Trial Site
Seattle, Washington, 98109
TG Therapeutics Investigational Trial Site
Tampa, Florida, 33612
TG Therapeutics Investigational Trial Site
Teaneck, New Jersey, 07666
TG Therapeutics Investigational Trial Site
Westerville, Ohio, 43081

Other trials in United States

Poland9 sites

TG Therapeutics Investigational Trial Site
Katowice, 40-555
TG Therapeutics Investigational Trial Site
Katowice, 40-568
TG Therapeutics Investigational Trial Site
Katowice, 40-684
TG Therapeutics Investigational Trial Site
Krakow, 31-505
TG Therapeutics Investigational Trial Site
Lodz, 41-800
TG Therapeutics Investigational Trial Site
Olsztyn, 10-561
TG Therapeutics Investigational Trial Site
Poznan, 61-583
TG Therapeutics Investigational Trial Site
Warsaw, 04-141
TG Therapeutics Investigational Trial Site
Zabrze, 04-749

Other trials in Poland

Georgia6 sites

TG Therapeutics Investigational Trial Site
Tbilisi, 00112
TG Therapeutics Investigational Trial Site
Tbilisi, 00114
TG Therapeutics Investigational Trial Site
Tbilisi, 00159
TG Therapeutics Investigational Trial Site
Tbilisi, 00160
TG Therapeutics Investigational Trial Site
Tbilisi, 00172
TG Therapeutics Investigational Trial Site
Tbilisi, 00179

Other trials in Georgia

Belarus5 sites

TG Therapeutics Investigational Trial Site
Grodno, 230017
TG Therapeutics Investigational Trial Site
Grodno, 320017
TG Therapeutics Investigational Trial Site
Minsk, 220114
TG Therapeutics Investigational Trial Site
Minsk, 220116
TG Therapeutics Investigational Trial Site
Minsk, 220226

Other trials in Belarus

Croatia3 sites

TG Therapeutics Investigational Trial Site
Osijek, 31000
TG Therapeutics Investigational Trial Site
Varaždin, 42000
TG Investigational Trial Site
Zagreb, 10000

Other trials in Croatia

Serbia2 sites

TG Therapeutics Investigational Trial Site
Belgrade, 11000
TG Therapeutics Investigational Trial Site
Kragujevac, 34000

Other trials in Serbia

About this study

Official title: An Open Label Extension Study of Ublituximab in Subjects With Relapsing Multiple Sclerosis

The purpose of this study is to evaluate long-term safety and efficacy of ublituximab therapy in participants with relapsing multiple sclerosis (RMS).

Read the detailed description

TG1101-RMS303 is an open-label, single-arm extension study designed to evaluate long-term safety and efficacy of ublituximab in participants with RMS. Participants who complete the 96-week, double-blind treatment period of TG1101-RMS301 (RMS301 [NCT03277261]) or TG1101-RMS302 (RMS302 [NCT03277248]) are eligible for participation in this Open Label Extension (OLE) study. Participants may also be eligible for TG1101-RMS303 if they have completed Week 208 of TG1101-RMS201E (RMS201E [NCT03381170]) (United States of America [USA] participants only).

Conditions: Relapsing Multiple Sclerosis (RMS)
Being tested: Ublituximab

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

UblituximabBiological
Also called TG-1101
Ublituximab (TG-1101) is a recombinant chimeric monoclonal antibody targeting CD20, available as a 25 mg/mL concentrate for intravenous use, supplied by TG Therapeutics, Inc.

Study groups in NCT04130997
Study group	Role	What they receive
Ublituximab Infusions	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. Receives: Biological: Ublituximab

What is being measured

The primary outcome is the main question the study is designed to answer.

Annualized Relapse Rate (ARR)
ARR is defined as the number of relapses per-participant year. The estimate of ARR will be the total number of relapses divided by the sum of duration on study treatment (years).
Measured: Up to Week 336

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Nov 201931 May 2032

First posted18 Oct 2019
Study start18 Nov 2019
Primary completion31 May 2032 (estimated)
Study completion31 May 2032 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Relapsing Multiple Sclerosis (RMS)Studies of the same condition, open and under way.
More trials run by TG Therapeutics, Inc.The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Model description: open-label, single-arm, extension study
Masking: None (open label)
Enrolment: 1,100 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04130997
Sponsor's protocol ID: TG1101-RMS303
Other IDs: 2019-003625-16, 2019
Status last verified: Oct 2026
First submitted: 16 Oct 2019
Last updated: 30 Oct 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

Cree BAC, Fox E, Hartung HP, Alvarez E, Qian P, Wray S, Robertson D, Selmaj K, Wynn D, Mok K, Rowland C, Bodhinathan K, Sportelli P, Miskin HP, Steinman L. Five Years of Ublituximab in Multiple Sclerosis: ULTIMATE I and II Open-Label Extension Study. JAMA Neurol. 2026 Apr 1;83(4):348-358. doi: 10.1001/jamaneurol.2026.0007.
PubMed 41697690

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
A Study Evaluating the Real World Experience of Participants Treated With BRIUMVI® (Ublituximab-xiiy) for Relapsing Multiple Sclerosis (RMS)
Relapsing Multiple Sclerosis, Multiple Sclerosis
RecruitingPhase 2/3
Study to Assess Effects of Ublituximab in Pediatric Participants With Relapsing Forms of Multiple Sclerosis
Relapsing Multiple Sclerosis
Active, not recruitingObservational study
Early Versus Late Ofatumumab (Kesimpta®) Use in Austrian RMS-Patients Over 2 Years
Relapsing Multiple Sclerosis
RecruitingPhase 3
Efficacy and Safety of Remibrutinib After Switching From Ocrelizumab in Participants Living With Relapsing Multiple Sclerosis.
Relapsing Multiple Sclerosis
Active, not recruitingPhase 3
A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, Radiological and Clinical Effects of Subcutaneous Ublituximab in Participants With Relapsing Multiple Sclerosis (RMS)
Relapsing Multiple Sclerosis

All Relapsing Multiple Sclerosis (RMS) trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open Label Extension Study of Ublituximab in Subjects With Relapsing Multiple Sclerosis
ClinicalTrials.gov ID: NCT04130997
Acronym / sponsor ID: TG1101-RMS303
Conditions: Relapsing Multiple Sclerosis (RMS)
Phase: Phase 3
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 1,100 participants (estimated)
Lead sponsor: TG Therapeutics, Inc.Industry (pharma, biotech, devices)
Study start: 18 Nov 2019 (actual)
Primary completion: 31 May 2032 (estimated)
Study completion: 31 May 2032 (estimated)
First posted: 18 Oct 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to evaluate long-term safety and efficacy of ublituximab therapy in participants with relapsing multiple sclerosis (RMS).

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: open-label, single-arm, extension study

Arm	Type	Receives
Ublituximab Infusions	Experimental	Biological: UblituximabRMS301/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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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
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

Key exclusion criteria (14 listed)

Participants who meet any of the following exclusion criteria are not to be enrolled to this study:
Any significant or uncontrolled medical condition or treatment-emergent, clinically significant laboratory abnormality such as:
Active infection
Ongoing pregnancy (female participants)
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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
UblituximabAlso: TG-1101Ublituximab (TG-1101) is a recombinant chimeric monoclonal antibody targeting CD20, available as a 25 mg/mL concentrate for intravenous use, supplied by TG Therapeutics, Inc.	Biological	Ublituximab Infusions

Primary outcome

Annualized Relapse Rate (ARR)
Time frame: Up to Week 336
ARR is defined as the number of relapses per-participant year. The estimate of ARR will be the total number of relapses divided by the sum of duration on study treatment (years).

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
Derived from this study: PubMed 41697690Cree BAC, Fox E, Hartung HP, Alvarez E, Qian P, Wray S, Robertson D, Selmaj K, Wynn D, Mok K, Rowland C, Bodhinathan K, Sportelli P, Miskin HP, Steinman L. Five Years of Ublituximab in Multiple Sclerosis: ULTIMATE I and II Open-Label Extension Study. JAMA Neurol. 2026 Apr 1;83(4):348-358. doi: 10.1001/jamaneurol.2026.0007.

Related trials for Relapsing Multiple Sclerosis (RMS)

RecruitingObservational study
A Study Evaluating the Real World Experience of Participants Treated With BRIUMVI® (Ublituximab-xiiy) for Relapsing Multiple Sclerosis (RMS)
Relapsing Multiple Sclerosis, Multiple Sclerosis
RecruitingPhase 2/3
Study to Assess Effects of Ublituximab in Pediatric Participants With Relapsing Forms of Multiple Sclerosis
Relapsing Multiple Sclerosis
Active, not recruitingObservational study
Early Versus Late Ofatumumab (Kesimpta®) Use in Austrian RMS-Patients Over 2 Years
Relapsing Multiple Sclerosis
RecruitingPhase 3
Efficacy and Safety of Remibrutinib After Switching From Ocrelizumab in Participants Living With Relapsing Multiple Sclerosis.
Relapsing Multiple Sclerosis
Active, not recruitingPhase 3
A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, Radiological and Clinical Effects of Subcutaneous Ublituximab in Participants With Relapsing Multiple Sclerosis (RMS)
Relapsing Multiple Sclerosis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

86 sites in 8 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ublituximab in people with Relapsing Multiple Sclerosis (RMS), run by TG Therapeutics, Inc. at 86 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 86 sites in Russia, Ukraine, United States, Poland, Georgia and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Annualized Relapse Rate (ARR) (time frame: Up to Week 336). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04130997, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.