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An Extension of the TG1101-RMS201 Trial

Sponsor
TG Therapeutics, Inc. (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT03381170
Collaborator
(none)
48
Enrollment
8
Locations
1
Arm
66
Anticipated Duration (Months)
6
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Biological: Ublituximab
 Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
48 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Jun 1, 2017
Anticipated Primary Completion Date :
Nov 30, 2022
Anticipated Study Completion Date :
Nov 30, 2022

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Number of participants with treatment-related events as assessed by CTCAE V4.0 [96 weeks on therapy]

      to determine the incidence of adverse events and any abnormal laboratory values

    Secondary Outcome Measures

    1. Evaluate the % of participants with relapses [up to 96 Weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 TG Therapeutics Investigational Trial Site Pasadena California United States 91105
    2 TG Therapeutics Investigational Trial Site Aurora Colorado United States 80045
    3 TG Therapeutics Investigational Trial Site Lexington Kentucky United States 40513
    4 TG Therapeutics Investigational Trial Site Columbus Ohio United States 43210
    5 TG Therapeutics Investigational Trial Site Westerville Ohio United States 43081
    6 TG Therapeutics Investigational Trial Site Knoxville Tennessee United States 37922
    7 TG Therapeutics Investigational Trial Site Round Rock Texas United States 78681
    8 TG Therapeutics Investigational Trial Site San Antonio Texas United States 78258

    Sponsors and Collaborators

    • TG Therapeutics, Inc.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    TG Therapeutics, Inc.
    ClinicalTrials.gov Identifier:
    NCT03381170
    Other Study ID Numbers:
    • TG1101-RMS201E
    First Posted:
    Dec 21, 2017
    Last Update Posted:
    Aug 22, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by TG Therapeutics, Inc.
    Relapsing Multiple Sclerosis
    Additional relevant MeSH terms:
    Multiple Sclerosis
    Multiple Sclerosis, Relapsing-Remitting
    Sclerosis

    Study Results

    No Results Posted as of Aug 22, 2022