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Phase 2 Study of Ublituximab in Patients With Relapsing Forms of Multiple Sclerosis

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ClinicalTrials.gov Identifier: NCT02738775
Recruitment Status : Completed
First Posted : April 14, 2016
Last Update Posted : October 2, 2019
Sponsor:
Information provided by (Responsible Party):
TG Therapeutics, Inc.

Brief Summary:
This study evaluates the use of single agent ublituximab, a novel monoclonal antibody, in patients with relapsing forms of multiple sclerosis

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Biological: Ublituximab Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: A Placebo-Controlled Multi-Center Phase 2 Study of Ublituximab, a Third-Generation Anti-CD20 Monoclonal Antibody, in Patients With Relapsing Forms of Multiple Sclerosis.
Actual Study Start Date : March 18, 2016
Actual Primary Completion Date : August 2018
Actual Study Completion Date : August 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Ublituximab
Ublituximab IV infusion dose on Day 1, 15 and Week 24
Biological: Ublituximab
Other Name: TG-1101

Placebo Comparator: Ublituximab Placebo
Placebo IV infusion dose on Day 1 and 15 only
Drug: Placebo



Primary Outcome Measures :
  1. B-cell depletion [ Time Frame: Day 28 ]
    Measure B-cell depletion up to day 28

  2. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: 6 months on therapy ]
    To determine the incidence of adverse events and any abnormal laboratory values


Secondary Outcome Measures :
  1. Evaluate the % of relapses in relapsed multiple sclerosis patients [ Time Frame: up to 48 weeks ]


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of relapsed multiple sclerosis
  • Active disease
  • Greater than 1 relapse in prior 2 years

Exclusion Criteria:

  • Treatment with anti-CD20 monoclonal antibody within the last 12 months
  • Treatment with alemtuzumab within the last 12 months
  • Pregnant or nursing mothers

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02738775


Locations
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United States, Arizona
TG Therapeutics Investigational Trial Site
Phoenix, Arizona, United States, 85018
United States, California
TG Therapeutics Investigational Trial Site
Pasadena, California, United States, 91105
TG Therapeutics Investigational Trial Site
Torrance, California, United States, 90502
United States, Colorado
TG Therapeutics Investigational Trial Site
Aurora, Colorado, United States, 80045
TG Therapeutics Investigational Trial Site
Fort Collins, Colorado, United States, 80528
United States, Kentucky
TG Therapeutics Investigational Trial Site
Lexington, Kentucky, United States, 40509
United States, New Jersey
TG Therapeutics Investigational Trial Site
Teaneck, New Jersey, United States, 07666
United States, Ohio
TG Therapeutics Investigational Trial Site
Akron, Ohio, United States, 44320
TG Therapeutics Investigational Trial Site
Columbus, Ohio, United States, 43201
United States, Tennessee
TG Therapeutics Investigational Trial Site
Knoxville, Tennessee, United States, 37922
United States, Texas
TG Therapeutics Investigational Trial Site
Round Rock, Texas, United States, 78681
TG Therapeutics Investigational Trial Site
San Antonio, Texas, United States, 78258
Sponsors and Collaborators
TG Therapeutics, Inc.
Investigators
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Study Chair: Edward Fox, MD, PhD Central Texas Neurology

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Responsible Party: TG Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT02738775     History of Changes
Other Study ID Numbers: TG1101-RMS-201
First Posted: April 14, 2016    Key Record Dates
Last Update Posted: October 2, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Data will be shared after study completion via publication
Keywords provided by TG Therapeutics, Inc.:
multiple sclerosis
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs