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An Open Label Extension Study of Ublituximab in Subjects With Relapsing Multiple Sclerosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04130997
Recruitment Status : Enrolling by invitation
First Posted : October 18, 2019
Last Update Posted : March 13, 2020
Sponsor:
Information provided by (Responsible Party):
TG Therapeutics, Inc.

Study Description
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Brief Summary:
An Open Label Extension Study of Ublituximab in Subjects with Relapsing Multiple Sclerosis

Condition or disease Intervention/treatment Phase
Relapsing Multiple Sclerosis (RMS) Biological: Ublituximab Phase 3

Detailed Description:
TG1101-RMS303 is an open-label, single-arm extension study designed to evaluate long-term safety and efficacy of ublituximab in subjects with Relapsing Multiple Sclerosis. Subjects who complete the 96-week, double-blind treatment period of TG1101-RMS301 or TG1101-RMS302 are eligible for participation in this Open Label Extension (OLE) study.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Intervention Model: Single Group Assignment
Intervention Model Description: open-label, single-arm, extension study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: TG1101-RMS303 is an Open-label, Single-arm Extension Study Designed to Evaluate Long-term Safety and Efficacy of Ublituximab in Subjects With Relapsing Multiple Sclerosis. Subjects Who Complete the 96-week, Double-blind Treatment Period o TG1101-RMS301 or TG1101-RMS302 Are Eligible for Participation in This Open Label Extension (OLE) Study.
Actual Study Start Date : November 18, 2019
Estimated Primary Completion Date : October 2023
Estimated Study Completion Date : October 2023

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Ublituximab Infusions

All subjects who sign consent for this study will receive an initial 4-hour infusion of 150 mg ublituximab followed by a 1-hour infusion of 450 mg ublituximab 14 days later. Subsequent infusions of ublituximab will be administered at 450 mg for 1-hour every 24 weeks.

Infusion treatment will continue for 168 weeks, or until physician or subject decision to withdraw from the study.

 Biological: Ublituximab
Ublituximab (TG-1101) is a recombinant chimeric monoclonal antibody targeting CD20, available as a 25 mg/mL concentrate for intravenous use, supplied by TG Therapeutics, Inc.


Outcome Measures
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Primary Outcome Measures :
  1. Relapses [ Time Frame: 24 weeks ]
    • Annualized Relapse Rate (ARR) is defined as the number of relapses per-subject year. The estimate of ARR will be the total number of relapses divided by the sum of duration on study treatment (years).


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Subjects must meet the following criteria:

  1. Complete the 96-week double-blind TG1101-RMS301 or TG1101-RMS302 study and have not withdrawn from the follow-up period (if entered follow-up period)
  2. Investigator believes may benefit from treatment with ublituximab
  3. Are able and willing to provide written informed consent (e.g., before the first infusion) and to comply with the study protocol
  4. Female subjects of child-bearing potential, and male partners must consent to use a medically acceptable method of contraception from consent, throughout the study period, and for 20 weeks after the last dose of ublituximab

Exclusion Criteria:

Subjects who meet any of the following exclusion criteria are not to be enrolled to this study:

  1. Any significant or uncontrolled medical condition or treatment-emergent, clinically significant laboratory abnormality such as:

    1. Absolute neutrophil count < 1.5 x 10e3/µL
    2. Hematocrit < 24%
    3. Platelet count < 150,000 cell/mm3
    4. Hypogammaglobulinemia IgG < 4.0 g/L
  2. Active infection
  3. Ongoing pregnancy (female subjects)
  4. Subjects who discontinued ublituximab treatment or withdrew consent from the TG1101-RMS301 or TG1101-RMS302 study during the 96-week evaluation period or withdrew consent from or during the follow-up period.
Contacts and Locations
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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): NCT04130997


Locations
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United States, Florida
TG Therapeutics Investigational Trial Site
Tampa, Florida, United States, 33612
United States, Nevada
TG Therapeutics Investigational Trial Site
Las Vegas, Nevada, United States, 89106
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
United States, Washington
TG Therapeutics Investigational Trial Site
Seattle, Washington, United States, 98109
Sponsors and Collaborators
TG Therapeutics, Inc.
More Information
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Responsible Party: TG Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT04130997    
Other Study ID Numbers: TG1101-RMS303
First Posted: October 18, 2019    Key Record Dates
Last Update Posted: March 13, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
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