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Ublituximab (Briumvi) for Early Forms of Relapsing Multiple Sclerosis

NCT07225361 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-03-17

No results posted yet for this study

Summary

In this prospective, open-label, single-arm, single-institution trial, the investigators will accomplish the following two aims:

1. study the safety and tolerability of Ublituximab (Briumvi) twice annually in participants with early MS over a treatment observation period of \~12 months.
2. study the pre- and post-treatment change in plasma neurofilament light chain, tested at baseline pre-Ublituximab treatment, and q24 weeks for 96 weeks post Ublituximab treatment initiation.

Conditions

Interventions

DRUG

Ublituximab

Currently, many care plans may defer initiating high-efficacy DMTs, such as Ublituximab, for patients who previously would have been previously considered to have clinically isolated syndrome or not definite MS because of safety concerns. Recent label updates including a case of progressive multifocal leukoencephalopathy and transaminase elevations may exacerbate this worry. However, emerging evidence suggests treatment at the earliest timepoint has important, favourable impacts on long-term MS outcomes, far outweighing safety risks. Data in this early-diagnosis MS population are however lacking, and robust safety and tolerability data, underscored by biomarkers that are relevant to people with early MS, will guide prescribers in clinical decision making and likely encourage early MS treatment adoption.

Sponsors & Collaborators

Principal Investigators

  • Farrah J Mateen, MD, PhD · Northwestern University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-28
Primary Completion
2029-03-15
Completion
2029-08-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07225361 on ClinicalTrials.gov