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Evaluating real-world experiences of patients treated with BRIUMVI® for relapsing multiple sclerosis

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

TG Therapeutics, Inc. · NCT06433752

This study is looking to see how well BRIUMVI® works and what side effects it has for people with relapsing multiple sclerosis in everyday settings.

Quick facts

Study typeObservational
Enrollment500 (estimated)
Ages18 Years and up
SexAll
SponsorTG Therapeutics, Inc. (industry)
Drugs / interventionsublituximab
Locations85 sites (Birmingham, Alabama and 84 other locations)
Trial IDNCT06433752 on ClinicalTrials.gov

What this trial studies

This observational study aims to assess the safety and effectiveness of BRIUMVI® (ublituximab-xiiy) in patients diagnosed with relapsing multiple sclerosis (RMS). It focuses on gathering insights into the treatment experiences of participants who have been prescribed this medication in a real-world setting. Participants will be monitored for their health outcomes and any side effects following their first infusion of BRIUMVI®. The study does not involve any experimental interventions, as it is designed to observe the existing treatment protocol.

Who should consider this trial

Good fit: Ideal candidates for this study are individuals with a confirmed diagnosis of relapsing multiple sclerosis who have not yet received BRIUMVI® treatment.

Not a fit: Patients who have received live vaccines recently or are currently participating in other interventional MS trials may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the real-world effectiveness and safety of BRIUMVI® for patients with relapsing multiple sclerosis.

How similar studies have performed: While this study is observational and focuses on real-world data, similar studies evaluating treatment experiences with other MS therapies have shown promising results.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Birmingham, Alabama and 84 other locations

+35 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Relapsing Multiple Sclerosis, Multiple Sclerosis

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.