Study to Assess the Efficacy and Safety of Ublituximab in Participants With Relapsing Forms of Multiple Sclerosis (RMS)
NCT ID: NCT03277248
Last Updated: 2021-12-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
545 participants
INTERVENTIONAL
2017-08-25
2020-11-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Ublituximab + Oral Placebo
Participants received ublituximab intravenous (IV) infusion, 150 milligrams (mg) over 4 hours (h) on Day 1 followed by 450 mg over 1 h on Days 15, 168, 336 and 504 (Week 72) along with the oral placebo tablet, once daily (QD) from Day 1 up to the last day of Week 95.
Ublituximab
Administered as an IV infusion.
Oral Placebo
Administered orally.
Teriflunomide + IV Placebo
Participants received teriflunomide 14 mg tablet, orally, QD from Day 1 up to the last day of Week 95 along with the placebo IV infusion on Days 1, 15, 168, 336 and 504 (Week 72).
Teriflunomide
Film coated tablets administered orally.
IV Placebo
Administered as an IV Infusion.
Interventions
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Ublituximab
Administered as an IV infusion.
Teriflunomide
Film coated tablets administered orally.
Oral Placebo
Administered orally.
IV Placebo
Administered as an IV Infusion.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Active disease
* Expanded disability status scale (EDSS) 0 - 5.5 (inclusive) at screening
Exclusion Criteria
* Treatment with the following therapies at any time prior to randomization: alemtuzumab, natalizumab, teriflunomide, leflunomide and Stem cell transplantation
* Diagnosed with primary progressive multiple sclerosis (PPMS)
* Pregnant or nursing
18 Years
55 Years
ALL
No
Sponsors
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TG Therapeutics, Inc.
INDUSTRY
Responsible Party
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Locations
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TG Therapeutics RMS Investigational Trial site
Phoenix, Arizona, United States
TG Therapeutics RMS Investigational Trial Site
Aurora, Colorado, United States
TG Therapeutics RMS Investigational Trial Site
Tampa, Florida, United States
TG Therapeutics RMS Investigational Trial Site
Lexington, Kentucky, United States
TG Therapeutics RMS Investigational Trial Site
Chesterfield, Missouri, United States
TG Therapeutics RMS Investigational Trial Site
Las Vegas, Nevada, United States
TG Therapeutics RMS Investigational Trial Site
Teaneck, New Jersey, United States
TG Therapeutics RMS Investigational Trial Site
Albuquerque, New Mexico, United States
TG Therapeutics RMS Investigational Trial Site
Patchogue, New York, United States
TG Therapeutics RMS Investigational Trial site
Columbus, Ohio, United States
TG Therapeutics RMS Investigational Trial Site
Pittsburgh, Pennsylvania, United States
TG Therapeutics RMS Investigational Trial site
San Antonio, Texas, United States
TG Therapeutics RMS Investigational Trial site
Seattle, Washington, United States
Countries
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References
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Alvarez E, Steinman L, Fox EJ, Hartung HP, Qian P, Wray S, Robertson D, Selmaj K, Wynn D, Mok K, Xu Y, Bodhinathan K, Miskin HP, Cree BAC. Improvements in no evidence of disease activity with ublituximab vs. teriflunomide in the ULTIMATE phase 3 studies in relapsing multiple sclerosis. Front Neurol. 2024 Oct 24;15:1473284. doi: 10.3389/fneur.2024.1473284. eCollection 2024.
Steinman L, Fox E, Hartung HP, Alvarez E, Qian P, Wray S, Robertson D, Huang D, Selmaj K, Wynn D, Cutter G, Mok K, Hsu Y, Xu Y, Weiss MS, Bosco JA, Power SA, Lee L, Miskin HP, Cree BAC; ULTIMATE I and ULTIMATE II Investigators. Ublituximab versus Teriflunomide in Relapsing Multiple Sclerosis. N Engl J Med. 2022 Aug 25;387(8):704-714. doi: 10.1056/NEJMoa2201904.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2017-000639-15
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
TG1101-RMS302
Identifier Type: -
Identifier Source: org_study_id