Back to resultsAn Extension of the TG1101-RMS201 Trial
Primary Purpose
Relapsing Remitting Multiple Sclerosis
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Ublituximab
Sponsored by
About this trial
This is an interventional treatment trial for Relapsing Remitting Multiple Sclerosis focused on measuring Relapsing Multiple Sclerosis
Eligibility Criteria
Inclusion Criteria:
- Subjects currently enrolled in TG1101-RMS201 trial
- Subjects who have completed three infusions of ublituximab (at Day 1, Day 15, and Week24, as specified in the TG1101-RMS201 protocol) and have completed the scheduled assessments up to the final 48-week visit
Exclusion Criteria:
- Subjects who discontinued ublituximab treatment or withdrew consent from the TG1101- RMS201 study during the 48-week evaluation period
- Subjects who have started any other immunomodulating or disease modifying therapy after completion of the TG1101-RMS201 trial
- Pregnant or nursing mothers
Sites / Locations
- TG Therapeutics Investigational Trial Site
- TG Therapeutics Investigational Trial Site
- TG Therapeutics Investigational Trial Site
- TG Therapeutics Investigational Trial Site
- TG Therapeutics Investigational Trial Site
- TG Therapeutics Investigational Trial Site
- TG Therapeutics Investigational Trial Site
- TG Therapeutics Investigational Trial Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Ublituximab
Arm Description
Ublituximab IV infusions on Weeks 1E, 24E, 48E, 72E and (6E
Outcomes
Primary Outcome Measures
Number of participants with treatment-related events as assessed by CTCAE V4.0
to determine the incidence of adverse events and any abnormal laboratory values
Secondary Outcome Measures
Evaluate the % of participants with relapses
Full Information
NCT ID
NCT03381170
First Posted
December 18, 2017
Last Updated
December 20, 2022
Sponsor
TG Therapeutics, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT03381170
Brief Title
An Extension of the TG1101-RMS201 Trial
Official Title
An Open Label Extension of the TG1101-RMS201 Trial, for Subjects Currently Enrolled in TG1101-RMS201Treated With Ublituximab for Relapsing Forms of Multiple Sclerosis
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
June 1, 2017 (Actual)
Primary Completion Date
November 11, 2022 (Actual)
Study Completion Date
November 11, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
TG Therapeutics, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study evaluates the long term use of a single agent ublituximab, a novel monoclonal antibody, in patients with relapsing forms of multiple sclerosis
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsing Remitting Multiple Sclerosis
Keywords
Relapsing Multiple Sclerosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ublituximab
Arm Type
Experimental
Arm Description
Ublituximab IV infusions on Weeks 1E, 24E, 48E, 72E and (6E
Intervention Type
Biological
Intervention Name(s)
Ublituximab
Other Intervention Name(s)
TG1101
Intervention Description
Enrolled Subjects will be infused with ublituximab on Weeks 1E, 24E, 48E, 72E and 96E
Primary Outcome Measure Information:
Title
Number of participants with treatment-related events as assessed by CTCAE V4.0
Description
to determine the incidence of adverse events and any abnormal laboratory values
Time Frame
96 weeks on therapy
Secondary Outcome Measure Information:
Title
Evaluate the % of participants with relapses
Time Frame
up to 96 Weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects currently enrolled in TG1101-RMS201 trial
Subjects who have completed three infusions of ublituximab (at Day 1, Day 15, and Week24, as specified in the TG1101-RMS201 protocol) and have completed the scheduled assessments up to the final 48-week visit
Exclusion Criteria:
Subjects who discontinued ublituximab treatment or withdrew consent from the TG1101- RMS201 study during the 48-week evaluation period
Subjects who have started any other immunomodulating or disease modifying therapy after completion of the TG1101-RMS201 trial
Pregnant or nursing mothers
Facility Information:
Facility Name
TG Therapeutics Investigational Trial Site
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40513
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Westerville
State/Province
Ohio
ZIP/Postal Code
43081
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37922
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Round Rock
State/Province
Texas
ZIP/Postal Code
78681
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78258
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
Data will be shared after study completion via publication
Learn more about this trial
An Extension of the TG1101-RMS201 Trial
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