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: | 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 II 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
13
sites
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