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: | Active, not recruiting |
|---|---|
| Conditions: | Neurology, Neurology |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 1/31/2019 |
| Start Date: | August 1, 2017 |
| End Date: | September 30, 2021 |
UbLiTuximab In Multiple Sclerosis Treatment Effects (ULTIMATE I STUDY)
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.
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.
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
We found this trial at
14
sites
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials