Brief Summary

The purpose of this study is to evaluate long-term safety and efficacy of ublituximab therapy in participants with relapsing multiple sclerosis (RMS).

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

1,100

participants targeted

Target at P75+ for phase_3

Timeline

74mo left

Started Nov 2019

Longer than P75 for phase_3

Geographic Reach

8 countries

86 active sites

Status

active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

12.5 years study duration

Study Progress52%

Nov 2019May 2032

First Submitted

Initial submission to the registry

October 16, 2019

Completed

2 days until next milestone

First Posted

Study publicly available on registry

October 18, 2019

Completed

1 month until next milestone

Study Start

First participant enrolled

November 18, 2019

Completed

12.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2032

Expected

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2032

Last Updated

April 8, 2026

Status Verified

April 1, 2026

Enrollment Period

12.5 years

First QC Date

October 16, 2019

Last Update Submit

April 2, 2026

Conditions

Relapsing Multiple Sclerosis (RMS)

Outcome Measures

Primary Outcomes (1)

Annualized Relapse Rate (ARR)
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).
Up to Week 336

Study Arms (1)

Ublituximab Infusions

EXPERIMENTAL

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 312. 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 312. For all participants (RMS301/RMS302/RMS201E), infusion treatment will continue for 312 weeks, or until physician or participant decision to withdraw from the study.

Biological: Ublituximab

Interventions

UblituximabBIOLOGICAL

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.

Also known as: TG-1101

Ublituximab Infusions

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Participants must meet the following criteria:
Complete the 96-week double-blind TG1101-RMS301 (NCT03277261) or TG1101-RMS302 (NCT03277248) study or complete the final Week 208 visit of the TG1101-RMS201E (NCT03381170) study
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 participants 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

You may not qualify if:

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/mm\^3
Hypogammaglobulinemia immunoglobulin G (IgG) \< 4.0g/L
Active infection
Ongoing pregnancy (female participants)
Participants who discontinued ublituximab treatment or withdrew consent from the TG1101-RMS301 or TG1101-RMS302 study during the 96-week evaluation period or prior to completing the final Week 208 visit of the TG1101-RMS201E study
Participants who have started any disease modifying therapy (DMT), stem cell transplantation, or participation in any other interventional clinical trial after completion of the 96-week visit in the TG1101-RMS301, TG1101-RMS302, or after completing the final Week 208 visit of the TG1101-RMS201E study
Participants who have had a confirmed multiple sclerosis (MS) relapse within the past 30 days prior to Week 1 Day 1 (W1D1). Following a relapse, participants must be neurologically stable for at least 30 days prior to screening or W1D1 of the OLE
Participants with unstable disease activity
Presence of malignancy, except for surgically excised basal or squamous cell skin lesions
Vaccination with live virus within 2 months of randomization

Contact the study team to confirm eligibility.