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
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
- 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