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 : February 3, 2021
|Condition or disease||Intervention/treatment||Phase|
|Relapsing Multiple Sclerosis (RMS)||Biological: Ublituximab||Phase 3|
|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)|
|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|
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.
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.
- 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).
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