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A Phase 3, Non-Inferiority, Randomized, Open-Label, Parallel Group, Multicenter Study To Evaluate The Pharmacokinetics, Pharmacodynamics, Safety, Radiological and Clinical Effects Of Subcutaneous Ublituximab Versus Intravenous Ublituximab In Patients With Multiple Sclerosis - TG1101-RMS-SC301

Trial Profile

A Phase 3, Non-Inferiority, Randomized, Open-Label, Parallel Group, Multicenter Study To Evaluate The Pharmacokinetics, Pharmacodynamics, Safety, Radiological and Clinical Effects Of Subcutaneous Ublituximab Versus Intravenous Ublituximab In Patients With Multiple Sclerosis - TG1101-RMS-SC301

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 05 Feb 2026

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At a glance

  • Drugs Ublituximab (Primary) ; Ublituximab
  • Indications Multiple sclerosis
  • Focus Pharmacokinetics; Registrational; Therapeutic Use
  • Sponsors TG Therapeutics Inc

Most Recent Events

  • 13 Jan 2026 According to the TG Therapeutics media release, company anticipates to announce pivotal topline data combining Day 1 and Day 15 doses of IV BRIUMVI from the trial in year-end 2026/1Q 2027
  • 03 Oct 2025 New trial record
  • 08 Sep 2025 According to the TG Therapeutics Media Release, company believe data from this trial would support a potential approval in 2028

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