Ublituximab (Briumvi) for Early Forms of Relapsing Multiple Sclerosis

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Northwestern University
Study ID
NCT07225361
Phase
PHASE4
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Ublituximab — DRUG
    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.

Study Details

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.

Key Dates

Start date
Nov 28, 2025
Status verified
Mar 2026
Primary completion
Mar 15, 2029
Completion
Aug 1, 2029

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Participants with Relapsing Multiple Sclerosis
    Participants with Relapsing Multiple Sclerosis will be treated with Ublituximab for the duration of the study.

Primary Outcome Measure

Change in plasma neurofilament light chain [ Time Frame: Time Frame: Baseline (pre-treatment), and at 24, 48, 72, and 96 weeks post-treatment initiation ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Northwestern Memorial HospitalChicagoIllinois60611
Caroline Gebczak, B.S.
[email protected]
630-313-0470
Dylan Rice, B.A.
[email protected]
240-362-4800
Farrah J Mateen, MD, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Chicago, IL

By condition
Multiple sclerosis
By specialty
NeurologyBrain disordersAutoimmune disease
By research site
Northwestern Memorial Hospital· Chicago, IL

Related Studies