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# FDA, TG Therapeutics Agree on Special Protocol for MS Studies
- URL: https://www.fdaweb.com/fda-tg-therapeutics-agree-on-special-protocol-for-ms-studies/
- Published: 2017-08-02T12:00:00.000Z
- Updated: 2026-09-14T22:38:24.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5139291

FDA and TG Therapeutics have reached an agreement on a special protocol assessment (SPA) on the design of two Phase 3 clinical trials for TG-1101 (ublituximab), a glyco-engineered anti-CD20 monoclonal antibody for treating relapsing forms of multiple sclerosis (RMS). “The SPA provides agreement that the two Phase 3 trial designs adequately address objectives that, if met, would support the regulatory submission for approval of TG-1101,” according to the company.

The two trials, called the ULTIMATE I and ULTIMATE II, are randomized, active-control studies comparing ublituximab to teriflunomide in subjects with RMS. The primary endpoint for each study is “annualized relapse rate” following 96 weeks of treatment, according to TG Therapeutics, and they it will enroll about 880 subjects.