An Extension of the TG1101-RMS201 Trial

December 20, 2022 updated by: TG Therapeutics, Inc.

An Open Label Extension of the TG1101-RMS201 Trial, for Subjects Currently Enrolled in TG1101-RMS201Treated With Ublituximab for Relapsing Forms of Multiple Sclerosis

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Pasadena, California, United States, 91105
        • TG Therapeutics Investigational Trial Site
    • Colorado
      • Aurora, Colorado, United States, 80045
        • TG Therapeutics Investigational Trial Site
    • Kentucky
      • Lexington, Kentucky, United States, 40513
        • TG Therapeutics Investigational Trial Site
    • Ohio
      • Columbus, Ohio, United States, 43210
        • TG Therapeutics Investigational Trial Site
      • Westerville, Ohio, United States, 43081
        • TG Therapeutics Investigational Trial Site
    • Tennessee
      • Knoxville, Tennessee, United States, 37922
        • TG Therapeutics Investigational Trial Site
    • Texas
      • Round Rock, Texas, United States, 78681
        • TG Therapeutics Investigational Trial Site
      • San Antonio, Texas, United States, 78258
        • TG Therapeutics Investigational Trial Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 53 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ublituximab
Ublituximab IV infusions on Weeks 1E, 24E, 48E, 72E and (6E
Biological: Ublituximab
Enrolled Subjects will be infused with ublituximab on Weeks 1E, 24E, 48E, 72E and 96E
Other Names:
  • TG1101

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with treatment-related events as assessed by CTCAE V4.0
Time Frame: 96 weeks on therapy
to determine the incidence of adverse events and any abnormal laboratory values
96 weeks on therapy

Secondary Outcome Measures

Outcome Measure
Time Frame
Evaluate the % of participants with relapses
Time Frame: up to 96 Weeks
up to 96 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

TG Therapeutics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2017

Primary Completion (Actual)

November 11, 2022

Study Completion (Actual)

November 11, 2022

Study Registration Dates

First Submitted

December 18, 2017

First Submitted That Met QC Criteria

December 18, 2017

First Posted (Actual)

December 21, 2017

Study Record Updates

Last Update Posted (Actual)

December 21, 2022

Last Update Submitted That Met QC Criteria

December 20, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TG1101-RMS201E

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

Data will be shared after study completion via publication

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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