A Study Evaluating the Real World Experience of Participants Treated With BRIUMVI® (Ublituximab-xiiy) for Relapsing Multiple Sclerosis (RMS) (ENABLE)

May 27, 2026 updated by: TG Therapeutics, Inc.

REal World ExperieNce With BRIUMVI® (UblituximAB-xiiy) Treated Patients: A Longitudinal REgistry Study (ENABLE)

The purpose of this study is to evaluate safety, effiectiveness, and to gain insight into the treatment experience of participants prescribed BRIUMVI® (ublituximab-xiiy) in the real-world setting

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Puerto Rico
      • Guaynabo, Puerto Rico, 00968
        • Recruiting
        • TG Therapeutics Investigational Trial Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35209
        • Recruiting
        • TG Therapeutics Investigational Trial Site
      • Huntsville, Alabama, United States, 35802
        • Recruiting
        • TG Therapeutics Investigational Trial Site
      • Mobile, Alabama, United States, 36604
        • Recruiting
        • TG Therapeutics Investigational Trial Site
    • Arizona
      • Gilbert, Arizona, United States, 85297
        • Recruiting
        • TG Therapeutics Investigational Trial Site
      • Phoenix, Arizona, United States, 85032
        • Recruiting
        • TG Therapeutics Investigational Trial Site
      • Scottsdale, Arizona, United States, 85253
        • Recruiting
        • TG Therapeutics Investigational Trial Site
    • California
      • Fresno, California, United States, 93720
        • Recruiting
        • TG Therapeutics Investigational Trial Site
      • Newport Beach, California, United States, 92663
        • Recruiting
        • TG Therapeutics Investigational Trial Site
      • Orange, California, United States, 68130
        • Recruiting
        • TG Therapeutics Investigational Trial Site
      • West Hollywood, California, United States, 90048
        • Recruiting
        • TG Therapeutics Investigational Trial Site
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • TG Therapeutics Investigational Trial Site
      • Basalt, Colorado, United States, 81621
        • Recruiting
        • TG Therapeutics Investigational Trial Site
      • Colorado Springs, Colorado, United States, 80918
        • Recruiting
        • TG Therapeutics Investigational Trial Site
      • Denver, Colorado, United States, 80222
        • Recruiting
        • TG Therapeutics Investigational Trial Site
      • Fort Collins, Colorado, United States, 80528
        • Recruiting
        • TG Therapeutics Investigational Trial Site
      • Grand Junction, Colorado, United States, 81501
        • Recruiting
        • TG Therapeutics Investigational Trial Site
    • Connecticut
      • Farmington, Connecticut, United States, 06032
        • Recruiting
        • TG Therapeutics Investigational Trial Site
      • Hartford, Connecticut, United States, 06112
        • Recruiting
        • TG Therapeutics Investigational Trial Site
    • Delaware
      • Wilmington, Delaware, United States, 19808
        • Recruiting
        • TG Therapeutics Investigational Trial Site
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20010
        • Recruiting
        • TG Therapeutics Investigational Trial Site
    • Florida
      • Altamonte Springs, Florida, United States, 32714
        • Recruiting
        • TG Therapeutics Investigational Trial Site
      • Boca Raton, Florida, United States, 33486
        • Recruiting
        • TG Therapeutics Investigational Trial Site
      • Clearwater, Florida, United States, 33761
        • Recruiting
        • TG Therapeutics Investigational Trial Site
      • Maitland, Florida, United States, 32751
        • Recruiting
        • TG Therapeutics Investigational Trial Site
      • Miami, Florida, United States, 33176
        • Recruiting
        • TG Therapeutics Investigational Trial Site
      • Naples, Florida, United States, 34105
        • Recruiting
        • TG Therapeutics Investigational Trial Site
      • Weston, Florida, United States, 33331
        • Recruiting
        • TG Therapeutics Investigational Trial Site
    • Georgia
      • Atlanta, Georgia, United States, 30309
        • Recruiting
        • TG Therapeutics Investigational Trial Site
      • Atlanta, Georgia, United States, 30327
        • Recruiting
        • TG Therapeutics Investigational Trial Site
      • Smyrna, Georgia, United States, 30080
        • Recruiting
        • TG Therapeutics Investigational Trial Site
    • Idaho
      • Coeur d'Alene, Idaho, United States, 83814
        • Recruiting
        • TG Therapeutics Investigational Trial Site
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Recruiting
        • TG Therapeutics Investigational Trial Site
      • Evanston, Illinois, United States, 60201
        • Recruiting
        • TG Therapeutics Investigational Trial Site
      • Urbana, Illinois, United States, 61801
        • Recruiting
        • TG Therapeutics Investigational Trial Site
    • Kentucky
      • Lexington, Kentucky, United States, 40504
        • Recruiting
        • TG Therapeutics Investigational Trial Site
      • Louisville, Kentucky, United States, 40202
        • Recruiting
        • TG Therapeutics Investigational Trial Site
    • Maryland
      • Baltimore, Maryland, United States, 21237
        • Recruiting
        • TG Therapeutics Investigational Trial Site
      • Glen Burnie, Maryland, United States, 21061
        • Recruiting
        • TG Therapeutics Investigational Trial Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • TG Therapeutics Investigational Trial Site
      • Burlington, Massachusetts, United States, 01805
        • Recruiting
        • TG Therapeutics Investigational Trial Site
      • Norfolk, Massachusetts, United States, 02481
        • Recruiting
        • TG Therapeutics Investigational Trial Site
    • Michigan
      • Ann Arbor, Michigan, United States, 48019
        • Recruiting
        • TG Therapeutics Investigational Trial Site
      • Farmington, Michigan, United States, 48334
        • Recruiting
        • TG Therapeutics Investigational Trial Site
      • Owosso, Michigan, United States, 48867
        • Recruiting
        • TG Therapeutics Investigational Trial Site
      • Rochester Hills, Michigan, United States, 48307
        • Recruiting
        • TG Therapeutics Investigational Trial Site
    • Montana
      • Billings, Montana, United States, 59101
        • Recruiting
        • TG Therapeutics Investigational Trial Site
    • Nebraska
      • Omaha, Nebraska, United States, 68154
        • Recruiting
        • TG Therapeutics Investigational Trial Site
    • Nevada
      • Las Vegas, Nevada, United States, 89106
        • Recruiting
        • TG Therapeutics Investigational Trial Site
    • New Jersey
      • Bridgewater, New Jersey, United States, 08807
        • Recruiting
        • TG Therapeutics Investigational Trial Site
      • Cherry Hill, New Jersey, United States, 08002
        • Recruiting
        • TG Therapeutics Investigational Trial Site
      • Freehold, New Jersey, United States, 07728
        • Recruiting
        • TG Therapeutics Investigational Trial Site
      • Livingston, New Jersey, United States, 07039
        • Recruiting
        • TG Therapeutics Investigational Trial Site
      • Neptune City, New Jersey, United States, 00753
        • Recruiting
        • TG Therapeutics Investigational Trial Site
      • Teaneck, New Jersey, United States, 07666
        • Recruiting
        • TG Therapeutics Investigational Trial Site
    • New York
      • Amherst, New York, United States, 14226
        • Recruiting
        • TG Therapeutics Investigational Trial Site
      • New York, New York, United States, 11501
        • Recruiting
        • TG Therapeutics Investigational Trial Site
    • North Carolina
      • Charlotte, North Carolina, United States, 28210
        • Recruiting
        • TG Therapeutics Investigational Trial Site
      • New Bern, North Carolina, United States, 28562
        • Recruiting
        • TG Therapeutics Investigational Trial Site
      • Raleigh, North Carolina, United States, 27607
        • Recruiting
        • TG Therapeutics Investigational Trial Site
    • Ohio
      • Centerville, Ohio, United States, 45429
        • Recruiting
        • TG Therapeutics Investigational Trial Site
      • Centerville, Ohio, United States, 45459
        • Recruiting
        • TG Therapeutics Investigational Trial Site
      • Cincinnati, Ohio, United States, 45212
        • Recruiting
        • TG Therapeutics Investigational Trial Site
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • TG Therapeutics Investigational Trial Site
      • Columbus, Ohio, United States, 43214
        • Recruiting
        • TG Therapeutics Investigational Trial Site
      • Toledo, Ohio, United States, 43608
        • Recruiting
        • TG Therapeutics Investigational Trial Site
    • Oklahoma
      • Norman, Oklahoma, United States, 73019
        • Recruiting
        • TG Therapeutics Investigational Trial Site
    • Oregon
      • Portland, Oregon, United States, 97225
        • Recruiting
        • TG Therapeutics Investigational Trial Site
    • Pennsylvania
      • Bethlehem, Pennsylvania, United States, 18017
        • Recruiting
        • TG Therapeutics Investigational Trial Site
    • Tennessee
      • Knoxville, Tennessee, United States, 37996
        • Recruiting
        • TG Therapeutics Investigational Trial Site
      • Nashville, Tennessee, United States, 37215
        • Recruiting
        • TG Therapeutics Investigational Trial Site
      • Spring Hill, Tennessee, United States, 37174
        • Recruiting
        • TG Therapeutics Investigational Trial Site
    • Texas
      • Austin, Texas, United States, 78723
        • Recruiting
        • TG Therapeutics Investigational Trial Site
      • Austin, Texas, United States, 78712
        • Recruiting
        • TG Therapeutics Investigational Trial Site
      • Austin, Texas, United States, 78758
        • Recruiting
        • TG Therapeutics Investigational Trial Site
      • Dallas, Texas, United States, 75206
        • Recruiting
        • TG Therapeutics Investigational Trial Site
      • Edinburg, Texas, United States, 78572
        • Recruiting
        • TG Therapeutics Investigational Trial Site
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • TG Therapeutics Investigational Trial Site
    • Utah
      • Ogden, Utah, United States, 84403
        • Recruiting
        • TG Therapeutics Investigational Trial Site
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • Recruiting
        • TG Therapeutics Investigational Trial Site
      • Norfolk, Virginia, United States, 23502
        • Recruiting
        • TG Therapeutics Investigational Trial Site
      • Vienna, Virginia, United States, 22182
        • Recruiting
        • TG Therapeutics Investigational Trial Site
    • Washington
      • Kirkland, Washington, United States, 98034
        • Recruiting
        • TG Therapeutics Investigational Trial Site
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • Recruiting
        • TG Therapeutics Investigational Trial Site
    • Wisconsin
      • Greenfield, Wisconsin, United States, 53228
        • Recruiting
        • TG Therapeutics Investigational Trial Site
      • Milwaukee, Wisconsin, United States, 53226
        • Recruiting
        • TG Therapeutics Investigational Trial Site
      • Neenah, Wisconsin, United States, 54956
        • Recruiting
        • TG Therapeutics Investigational Trial Site
      • Waukesha, Wisconsin, United States, 53188
        • Recruiting
        • TG Therapeutics Investigational Trial Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

The study population will include participants with RMS who are receiving BRIUMVI® (ublituximab-xiiy).

Description

Inclusion Criteria:

  1. Confirmed Multiple Sclerosis (MS) diagnosis.
  2. Participants who have not received any BRIUMVI® (ublituximab-xiiy) infusion prior to study start. Participants who have been prescribed BRIUMVI® (ublituximab-xiiy) but have not yet received their first infusion on Day 1 of 150 milligrams (mg) can be included.

Exclusion Criteria:

  1. Have received any live or live-attenuated vaccines (including for varicella-zoster virus or measles) within 4 weeks prior to first BRIUMVI® (ublituximab-xiiy) administration or any non-live vaccines within 2 weeks prior to first BRIUMVI® (ublituximab-xiiy) administration.
  2. Any active infection (e.g., active Hepatitis B virus [HBV])
  3. Concurrent participation in any interventional MS trials, or planned concurrent treatment with other Multiple Sclerosis Disease Modifying Therapy (MS DMT) during the study period.

Study Plan

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

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
BRIUMVI® (Ublituximab-xiiy)
Participants will receive BRIUMVI® (Ublituximab-xiiy) intravenous (IV) infusion for the treatment of RMS.
Other: No Intervention
No Intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Annualized Relapse Rate (ARR)
Time Frame: Up to Week 96
Up to Week 96

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame: Up to Week 96
Up to Week 96
Number of Participants with Infusion Related Reaction (IRR) at Each Infusion
Time Frame: Up to Week 96
Up to Week 96

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

TG Therapeutics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 22, 2024

Primary Completion (Estimated)

April 1, 2032

Study Completion (Estimated)

April 1, 2032

Study Registration Dates

First Submitted

May 23, 2024

First Submitted That Met QC Criteria

May 23, 2024

First Posted (Actual)

May 30, 2024

Study Record Updates

Last Update Posted (Actual)

May 29, 2026

Last Update Submitted That Met QC Criteria

May 27, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TG1101-RMS406

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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