Overview

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

Status:
Completed
Trial end date:
2020-11-06
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