Status:
COMPLETED
Study to Assess the Efficacy and Safety of Ublituximab in Participants With Relapsing Forms of Multiple Sclerosis (RMS) ( ULTIMATE 1 )
Lead Sponsor:
TG Therapeutics, Inc.
Conditions:
Relapsing Multiple Sclerosis (RMS)
Eligibility:
All Genders
18-55 years
Phase:
PHASE3
Brief Summary
This study determines the Annualized Relapse Rate (ARR) in participants with RMS after 96 weeks (approximately 2 years) treatment with intravenous (IV) infusion of ublituximab/oral placebo compared to...
Eligibility Criteria
Inclusion
- 18-55 age
- Diagnosis of RMS (McDonald criteria 2010)
- Active disease
- Expanded disability status scale (EDSS) 0-5.5 (inclusive) at screening
Exclusion
- Treatment with prior Anti-cluster of differentiate 20 (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
Key Trial Info
Start Date :
September 19 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 6 2020
Estimated Enrollment :
549 Patients enrolled
Trial Details
Trial ID
NCT03277261
Start Date
September 19 2017
End Date
November 6 2020
Last Update
December 6 2021
Active Locations (14)
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1
TG Therapeutics RMS Investigational Trial Site
Carlsbad, California, United States, 92001
2
TG Therapeutics RMS Investigational Trial Site
Long Beach, California, United States, 90808
3
TG Therapeutics RMS Investigational Trial Site
Pasadena, California, United States, 91105
4
TG Therapeutics RMS Investigational Trial Site
Stanford, California, United States, 94305