Phase IIa Study of Ublituximab in Participants With Relapsing Forms of Multiple Sclerosis
NCT ID: NCT02738775
Last Updated: 2021-07-15
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
49 participants
INTERVENTIONAL
2016-05-27
2018-08-13
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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Cohort 1
Participant received intravenous (IV) infusion of ublituximab 150 milligrams (mg)/4 hour (hr) on Day 1, 450 mg/3 hr on Day 15 and 450 mg/1.5 hr on Week 24. Some participants initially received placebo IV infusion /4 hr on Day 1 and /3 hr on Day 15 before receiving ublituximab.
Ublituximab
Administered as an IV infusion.
Placebo
Cohort 2
Participant received IV infusion of ublituximab 150 mg/4 hr on Day 1, 450 mg/1.5 hr on Day 15 and 450 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /4 hr on Day 1 and /1.5 hr on Day 15 before receiving ublituximab.
Ublituximab
Administered as an IV infusion.
Placebo
Cohort 3
Participant received IV infusion of ublituximab 150 mg/4 hr on Day 1, 450 mg/1 hr on Day 15 and 600 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /4 hr on Day 1 and /1 hr on Day 15 before receiving ublituximab.
Ublituximab
Administered as an IV infusion.
Placebo
Cohort 4
Participant received IV infusion of ublituximab 150 mg/3 hr on Day 1, 600 mg/1 hr on Day 15 and 600 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /3 hr on Day 1 and /1 hr on Day 15 before receiving ublituximab.
Ublituximab
Administered as an IV infusion.
Placebo
Cohort 5
Participant received IV infusion of ublituximab 150 mg/2 hr on Day 1, 600 mg/1 hr on Day 15 and 600 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /2 hr on Day 1 and /1 hr on Day 15 before receiving ublituximab.
Ublituximab
Administered as an IV infusion.
Placebo
Cohort 6
Participant received IV infusion of ublituximab 150 mg/1 hr on Day 1, 600 mg/1 hr on Day 15 and 600 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /1 hr on Day 1 and /1 hr on Day 15 before receiving ublituximab.
Ublituximab
Administered as an IV infusion.
Placebo
Interventions
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Ublituximab
Administered as an IV infusion.
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Active disease
* Greater than or equal to (≥) 2 relapses in prior 2 years or 1 relapse in the year prior to screening and/or ≥1 gadolinium (Gd) enhancing lesion
Exclusion Criteria
* Treatment with alemtuzumab within the last 12 months
* Pregnant or nursing mothers
18 Years
55 Years
ALL
No
Sponsors
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TG Therapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Edward Fox, MD, PhD
Role: STUDY_CHAIR
Central Texas Neurology
Locations
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TG Therapeutics Investigational Trial Site
Phoenix, Arizona, United States
TG Therapeutics Investigational Trial Site
Pasadena, California, United States
TG Therapeutics Investigational Trial Site
Torrance, California, United States
TG Therapeutics Investigational Trial Site
Aurora, Colorado, United States
TG Therapeutics Investigational Trial Site
Fort Collins, Colorado, United States
TG Therapeutics Investigational Trial Site
Lexington, Kentucky, United States
TG Therapeutics Investigational Trial Site
Teaneck, New Jersey, United States
TG Therapeutics Investigational Trial Site
Akron, Ohio, United States
TG Therapeutics Investigational Trial Site
Columbus, Ohio, United States
TG Therapeutics Investigational Trial Site
Knoxville, Tennessee, United States
TG Therapeutics Investigational Trial Site
Round Rock, Texas, United States
TG Therapeutics Investigational Trial Site
San Antonio, Texas, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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TG1101-RMS-201
Identifier Type: -
Identifier Source: org_study_id
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