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

Recruiting

• Conditions: Relapsing Multiple Sclerosis; Multiple Sclerosis
• Interventions: Other: No Intervention

• Registration Number: NCT06433752
• Lead Sponsor: TG Therapeutics, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-05-23
• Study First Submitted QC: 2024-05-23
• Study First Posted: 2024-05-30
• Study Start: 2024-07-22
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-30
• Last Update Posted: 2025-05-04
• Primary Completion: 2027-07-01
• Study Completion: 2027-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
BRIUMVI® (Ublituximab-xiiy)	No Intervention	Participants will receive BRIUMVI® (Ublituximab-xiiy) intravenous (IV) infusion for the treatment of RMS.

Primary Outcome Measures

Name	Time	Method
Annualized Relapse Rate (ARR)	Up to Week 96

Secondary Outcome Measures

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

Trial Locations

Locations (1)

TG Therapeutics Investigational Trial Site; 🇵🇷 Guaynabo, Puerto Rico