information: Initiation of patient enrollment
Announcement: completion of patient enrollment
Company: TG Therapeutics (USA - NY)
Product: TG-1101 (ublituximab)
- monoclonal antibody. TG-1101 (ublituximab) is a glycoengineered monoclonal antibody that targets a unique epitope on the B-lymphocyte CD20 antigen.
Disease: multiple sclerosis
area: Autoimmune diseases - Neurodegenerative diseases
- ULTIMATE (UbLiTuximab In Multiple Sclerosis Treatment Effects) I and II are two independent Phase 3 clinical trials evaluating the safety and efficacy of TG-1101 (ublituximab), as compared to teriflunomide, in patients with relapsing forms of multiple sclerosis. The primary endpoint for each study is Annualized Relapse Rate (ARR) following 96 weeks of treatment. These studies are being led by Dr. Lawrence Steinman, of Stanford University and are being conducted under a Special Protocol Assessment (SPA) agreement with the FDA. (NCT03277261 and NCT03277248)
- • On August 7, 2018, TG Therapeutics announced that target enrollment in the ULTIMATE I and II Phase 3 trials has been achieved. While target enrollment has been reached, in order to provide an opportunity for patients already identified to participate, enrollment is expected to continue until mid-September.
- • On September 15, 2017, TG Therapeutics announced that enrollment is now open for the Phase 3 ULTIMATE I and II trials. Each trial will enroll approximately 440 subjects, randomized in a 1:1 ratio, with approximately 880 patients to be enrolled across both trials