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A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, Radiological and Clinical Effects of Subcutaneous Ublituximab in Participants With Relapsing Multiple Sclerosis (RMS)

StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Eligibility criteria expanded, about 8 words
  2. 3 versions Re-verified since Jun 17, 2026, no change to tracked fieldsv10-v12
  3. Trial sites expanded: 42 → 48 locationsv9
  4. Trial status changed: Recruiting → Active, Not Recruiting Primary completion moved earlier from Dec 31, 2026 to Oct 31, 2026 · Site details revised at 42 of 42 sitesv8 Show 2 more changesShow less
    • Primary completion moved earlier from Dec 31, 2026 to Oct 31, 2026
    • Site details revised at 42 of 42 sites
  5. 2 versions Re-verified since Feb 25, 2026, no change to tracked fieldsv6-v7
Show 4 earlier versionsHide 4 earlier versions
  1. Primary endpoint revised Secondary endpoints: 4 to 12 · Eligibility criteria expanded, about 1 wordv5 Show 2 more changesShow less
    • Secondary endpoints: 4 to 12
    • Eligibility criteria expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  2. Study sites: 20 to 42v4
  3. Site details revised at 4 of 20 sitesv3
  4. Study sites: 10 to 20v2
  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The purpose of this study is to assess the pharmacokinetics of ublituximab when administered subcutaneously (SC) compared to intravenous (IV) administration in participants with RMS.
Trial Details
NCT Number NCT07211633
Lead Sponsor TG Therapeutics, Inc.
Conditions Relapsing Multiple Sclerosis
Enrollment 360 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov