Brief Summary

This study evaluates the long term use of a single agent ublituximab, a novel monoclonal antibody, in patients with relapsing forms of multiple sclerosis

Trial Health

On Track

Trial Health Score

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

Enrollment

participants targeted

Target at P25-P50 for phase_2

Timeline

Completed

Started Jun 2017

Longer than P75 for phase_2

Geographic Reach

1 country

8 active sites

Status

completed

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

5.4 years study duration

Study Start

First participant enrolled

June 1, 2017

Completed

7 months until next milestone

First Submitted

Initial submission to the registry

December 18, 2017

Completed

3 days until next milestone

First Posted

Study publicly available on registry

December 21, 2017

Completed

4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 11, 2022

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 11, 2022

Completed

Last Updated

December 21, 2022

Status Verified

December 1, 2022

Enrollment Period

5.4 years

First QC Date

December 18, 2017

Last Update Submit

December 20, 2022

Conditions

Relapsing Remitting Multiple Sclerosis

Keywords

Relapsing Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

Number of participants with treatment-related events as assessed by CTCAE V4.0
to determine the incidence of adverse events and any abnormal laboratory values
96 weeks on therapy

Secondary Outcomes (1)

Evaluate the % of participants with relapses
up to 96 Weeks

Study Arms (1)

Ublituximab

EXPERIMENTAL

Ublituximab IV infusions on Weeks 1E, 24E, 48E, 72E and (6E

Biological: Ublituximab

Interventions

UblituximabBIOLOGICAL

Enrolled Subjects will be infused with ublituximab on Weeks 1E, 24E, 48E, 72E and 96E

Also known as: TG1101

Ublituximab

Eligibility Criteria

Age18 Years - 55 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64)

You may qualify if:

Subjects currently enrolled in TG1101-RMS201 trial
Subjects who have completed three infusions of ublituximab (at Day 1, Day 15, and Week24, as specified in the TG1101-RMS201 protocol) and have completed the scheduled assessments up to the final 48-week visit

You may not qualify if:

Subjects who discontinued ublituximab treatment or withdrew consent from the TG1101- RMS201 study during the 48-week evaluation period
Subjects who have started any other immunomodulating or disease modifying therapy after completion of the TG1101-RMS201 trial
Pregnant or nursing mothers

Contact the study team to confirm eligibility.