An Extension Study of Ublituximab in Participants 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 : May 12, 2022
|Condition or disease||Intervention/treatment||Phase|
|Relapsing Multiple Sclerosis (RMS)||Biological: Ublituximab||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||900 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||open-label, single-arm, extension study|
|Masking:||None (Open Label)|
|Official Title:||An Open Label Extension Study of Ublituximab in Subjects With Relapsing Multiple Sclerosis|
|Actual Study Start Date :||November 18, 2019|
|Estimated Primary Completion Date :||October 2023|
|Estimated Study Completion Date :||October 2023|
Experimental: Ublituximab Infusions
RMS301/RMS302: All participants transferring from RMS301/RMS302 who sign consent for this study will receive an initial 4-hour infusion of 150 mg ublituximab on Week 1 (Day 1) followed by a 1-hour infusion of 450 mg ublituximab 14 days later Week 3 (Day 15). Subsequent infusions of ublituximab will be administered at 450 mg for 1-hour every 24 weeks from Weeks 24 to 168.
RMS201E: All participants transferring from RMS201E who sign consent for this study will receive a 1-hour infusion of 450 mg ublituximab on Week 1 (Day 1) and subsequent infusions of ublituximab will be administered at 450 mg for 1-hour every 24 weeks from Weeks 24 to 168.
For all participants (RMS301/RMS302/RMS201E), infusion treatment will continue for 168 weeks, or until physician or participant 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.
Other Name: TG-1101
- Annualized Relapse Rate (ARR) [ Time Frame: Up to Week 172 ]ARR is defined as the number of relapses per-participant 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