An Open Label Extension Study of Ublituximab in Subjects With Relapsing Multiple Sclerosis
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ClinicalTrials.gov Identifier: NCT04130997 |
Recruitment Status :
Enrolling by invitation
First Posted : October 18, 2019
Last Update Posted : February 3, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Relapsing Multiple Sclerosis (RMS) | Biological: Ublituximab | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 1000 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Intervention Model Description: | open-label, single-arm, extension study |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |

Arm | Intervention/treatment |
---|---|
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. |
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. |
- 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).

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Subjects must meet the following criteria:
- 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)
- Investigator believes may benefit from treatment with ublituximab
- Are able and willing to provide written informed consent (e.g., before the first infusion) and to comply with the study protocol
- 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:
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Any significant or uncontrolled medical condition or treatment-emergent, clinically significant laboratory abnormality such as:
- Absolute neutrophil count < 1.5 x 10e3/µL
- Hematocrit < 24%
- Platelet count < 150,000 cell/mm3
- Hypogammaglobulinemia IgG < 4.0 g/L
- Active infection
- Ongoing pregnancy (female subjects)
- 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.

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

Responsible Party: | TG Therapeutics, Inc. |
ClinicalTrials.gov Identifier: | NCT04130997 |
Other Study ID Numbers: |
TG1101-RMS303 |
First Posted: | October 18, 2019 Key Record Dates |
Last Update Posted: | February 3, 2021 |
Last Verified: | February 2021 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Multiple Sclerosis Sclerosis Pathologic Processes Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System |
Nervous System Diseases Demyelinating Diseases Autoimmune Diseases Immune System Diseases |