UbLiTuximab In Multiple Sclerosis Treatment Effects (ULTIMATE I STUDY)
Phase of Trial: Phase III
Latest Information Update: 15 Sep 2017
At a glance
- Drugs Ublituximab (Primary) ; Teriflunomide
- Indications Multiple sclerosis
- Focus Registrational; Therapeutic Use
- Acronyms ULTIMATE I
- Sponsors TG Therapeutics Inc
- 15 Sep 2017 According to a TG Therapeutics media release, global ULTIMATE I and II trials are being led by Dr. Lawrence Steinman.
- 07 Sep 2017 Status changed from planning to recruiting.
- 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.