A Phase 3, Randomized, Multi-center, Double-blinded, Active-controlled Study to Assess the Efficacy and Safety/Tolerability of Ublituximab (TG-1101; UTX) as Compares to Teriflunomide in Subjects With Relapsing Multiple Sclerosis (RMS) (ULTIMATE 2)

• Status: Completed
• Trial end date: 2020-11-12
• Target enrollment: 0
• Participant gender: All

Summary

This is a phase 3, randomized, multi-center, double-blinded, active-controlled study that is primarily designed to assess the Annualized Relapse Rate (ARR) and safety/tolerability of ublituximab/oral placebo (TG-1101; UTX) as compared to teriflunomide/ IV placebo in subjects with relapsing MS.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: TG Therapeutics, Inc.
• Treatments: Teriflunomide

Criteria

Inclusion Criteria:

• 18 - 55 age

• Diagnosis of RMS (McDonald Criteria 2010)

• Active disease

• Expanded disability status scale (EDSS) 0 - 5.5 (inclusive) at screening

Exclusion Criteria:

• Treatment with prior Anti-CD20 or other B cell directed treatment

• Treatment with the following therapies at any time prior to randomization:

Alemtuzumab, Natalizumab, teriflunomide, Leflunomide and Stem cell transplantation

• Diagnosed with Primary Progressive MS (PPMS)

• Pregnant or nursing