First global, randomized, multi-center, double-blinded, double-dummy, active-controlled study comparing TG-1101 (ublituximab) to teriflunomide in subjects with relapsing forms of multiple sclerosis

Trial Profile

First global, randomized, multi-center, double-blinded, double-dummy, active-controlled study comparing TG-1101 (ublituximab) to teriflunomide in subjects with relapsing forms of multiple sclerosis

Planning
Phase of Trial: Phase III

Latest Information Update: 01 Aug 2017

At a glance

  • Drugs Ublituximab (Primary) ; Teriflunomide
  • Indications Multiple sclerosis
  • Focus Registrational; Therapeutic Use
  • Acronyms ULTIMATE I
  • Sponsors TG Therapeutics Inc
  • Most Recent Events

    • 01 Aug 2017 According to a TG Therapeutics media release, the company has reached an agreement with the US FDA regarding a Special Protocol Assessment (SPA) on the design of this trial. The SPA provides agreement that ULTIMATE I and II trial designs adequately address objectives that, if met, would support the regulatory submission for approval of TG-1101.
    • 01 Aug 2017 According to a TG Therapeutics media release, this trial is expected to commence before the end of Q3 2017. Lawrence Steinman will be the study chair for this trial.
    • 06 May 2016 New trial record
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