ClinicalTrials.gg
CompletedNCT03381170Updated Dec 21, 2022

An Extension of the TG1101-RMS201 Trial

A Phase 2 interventional study of Ublituximab in Relapsing Remitting Multiple Sclerosis, sponsored by TG Therapeutics, Inc.. Completed at 8 sites in United States. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2022-12-21.

Sponsored by TG Therapeutics, Inc. · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Nov 2022, 4 years ago, and no results have been posted to the registry.
  • Registered 6 months after the study started (first participant enrolled Jun 2017, registered Dec 2017).

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Phase
Phase 2
Study type
Interventional
Enrollment
48
Allocation
Not applicable
Ages
18 Years to 55 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 229 studies in Multiple Sclerosis, Relapsing-Remitting with a site in United States — 26 open to participants now, 44 under way, 7 of them phase 3. Multiple Sclerosis, Relapsing-Remitting · United States.

Enrollment
104th of 175
48 · median 65
Started
2017
with 10 others
Phase 2
40 of 229
1 open now
Registered
137th of 229
by date

Among the 229 studies in Multiple Sclerosis, Relapsing-Remitting with a site in United States, this one is the 104th largest by enrollment of the 175 interventional ones that give a count, is one of 11 that started in 2017, is one of 40 in phase 2, and was the 137th registered.

Multiple Sclerosis, Relapsing-Remitting

618 studies on the registry are indexed under Multiple Sclerosis, Relapsing-Remitting; 83 are open to participants now.

Browse Multiple Sclerosis, Relapsing-Remitting studies →

Open to participants now

26 of the 229 studies in Multiple Sclerosis, Relapsing-Remitting with a site in United States are open now. Recruiting first, the newest first:

21 more — sign in →

All 26 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 60 Multiple Sclerosis, Relapsing-Remitting studies recruiting now, 11 (18%) set no upper age limit and 43 (72%) stop at 75 or younger; 2 take children under 18; 11 take healthy volunteers.

This study: 18 Years to 55 Years · all sexes · no healthy volunteers.

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02

Study 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

03

Conditions studied

  • Relapsing Remitting Multiple Sclerosis

Keywords

  • Relapsing Multiple Sclerosis
04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
48 participants (actual)

Study arms

  • Experimental
    Ublituximab

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

    Biological: Ublituximab

Interventions

  • BiologicalUblituximab

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

    Also known as: TG1101

06

What researchers measure

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

    Time frame: 96 weeks on therapy

Secondary outcomes

  1. Evaluate the % of participants with relapses

    Time frame: up to 96 Weeks

07

Study locations

8 sites
  • TG Therapeutics Investigational Trial Site
    Pasadena, California 91105, United States
  • TG Therapeutics Investigational Trial Site
    Aurora, Colorado 80045, United States
  • TG Therapeutics Investigational Trial Site
    Lexington, Kentucky 40513, United States
  • TG Therapeutics Investigational Trial Site
    Columbus, Ohio 43210, United States
  • TG Therapeutics Investigational Trial Site
    Westerville, Ohio 43081, United States
  • TG Therapeutics Investigational Trial Site
    Knoxville, Tennessee 37922, United States
  • TG Therapeutics Investigational Trial Site
    Round Rock, Texas 78681, United States
  • TG Therapeutics Investigational Trial Site
    San Antonio, Texas 78258, United States
08

References and documents

Individual participant data

Plan to share: Undecided — Data will be shared after study completion via publication

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jun 2017 to primary completion in Nov 2022, 65 months.

Of 25 phase 2 interventional studies under Multiple Sclerosis, Relapsing-Remitting, half reached primary completion within 41 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 67. This study's 65 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 18, 2017
First posted
Dec 21, 2017
StartActual
Jun 1, 2017
Primary completionActual
Nov 11, 2022
CompletionActual
Nov 11, 2022
Last update
Dec 21, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 21, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03381170
Responsible party
Sponsor
First posted
Dec 21, 2017
Start date
Jun 1, 2017
Primary completion
Nov 11, 2022
Completion
Nov 11, 2022
Last update
Dec 21, 2022

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Ublituximab

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