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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 : October 15, 2021
Sponsor:
Information provided by (Responsible Party):
TG Therapeutics, Inc.

Tracking Information
First Submitted Date  ICMJE October 16, 2019
First Posted Date  ICMJE October 18, 2019
Last Update Posted Date October 15, 2021
Actual Study Start Date  ICMJE November 18, 2019
Estimated Primary Completion Date October 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 16, 2019)
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE An Open Label Extension Study of Ublituximab in Subjects With Relapsing Multiple Sclerosis
Official Title  ICMJE 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.
Brief Summary An Open Label Extension Study of Ublituximab in Subjects with Relapsing Multiple Sclerosis
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
open-label, single-arm, extension study
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Relapsing Multiple Sclerosis (RMS)
Intervention  ICMJE 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.
Study Arms  ICMJE 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.

Intervention: Biological: Ublituximab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: October 16, 2019)
1000
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2023
Estimated Primary Completion Date October 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belarus,   Croatia,   Georgia,   Poland,   Russian Federation,   Serbia,   Ukraine,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04130997
Other Study ID Numbers  ICMJE TG1101-RMS303
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party TG Therapeutics, Inc.
Study Sponsor  ICMJE TG Therapeutics, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account TG Therapeutics, Inc.
Verification Date October 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP