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Ublituximab (Briumvi) for Early Forms of Relapsing Multiple Sclerosis

StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Site contact updatedv4
  2. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Nov 25, 2025 to Nov 28, 2025
    • Site details revised
    v3
  3. Start date: Nov 1, 2025 to Nov 25, 2025v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07225361
Lead Sponsor Northwestern University
Collaborators: TG Therapeutics, Inc.
Conditions
(from sponsor)		 Multiple Sclerosis, Multiple Sclerosis (MS) - Relapsing-remitting
Related terms Multiple Sclerosis, Multiple Sclerosis, Relapsing-Remitting
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov