Brief Summary

This study determines the Annualized Relapse Rate (ARR) in participants with RMS after 96 weeks (approximately 2 years) treatment with intravenous (IV) infusion of ublituximab/oral placebo compared to 14 mg oral teriflunomide/IV placebo.

Trial Health

On Track

Trial Health Score

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

Enrollment

545

participants targeted

Target at P75+ for phase_3

Timeline

Completed

Started Aug 2017

Typical duration for phase_3

Geographic Reach

1 country

13 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

3.2 years study duration

Study Start

First participant enrolled

August 25, 2017

Completed

13 days until next milestone

First Submitted

Initial submission to the registry

September 7, 2017

Completed

4 days until next milestone

First Posted

Study publicly available on registry

September 11, 2017

Completed

2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 4, 2020

Completed

3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 12, 2020

Completed

1.1 years until next milestone

Results Posted

Study results publicly available

December 6, 2021

Completed

Last Updated

December 6, 2021

Status Verified

November 1, 2021

Enrollment Period

2.9 years

First QC Date

September 7, 2017

Results QC Date

November 11, 2021

Last Update Submit

November 11, 2021

Conditions

Relapsing Multiple Sclerosis (RMS)

Outcome Measures

Primary Outcomes (1)

Annualized Relapse Rate (ARR)
ARR is defined as the number of Independent Relapse Adjudication Committee (IRAP)-confirmed relapses per participant year. The estimate of ARR for a treatment group is the total number of relapses for participants in the respective treatment group divided by the sum of treatment duration for participants in that specific treatment group.
Up to 96 weeks

Secondary Outcomes (7)

Total Number of Gadolinium (Gd)-Enhancing T1-Lesions Per Magnetic Resonance Imaging (MRI) Scan Per Participant
Weeks 12, 24, 48, and 96
Total Number of New and Enlarging T2 Hyperintense Lesions (NELs) Per MRI Scan Per Participant
Weeks 24, 48, and 96
Time to Confirmed Disability Progression (CDP) for at Least 12 Weeks
Up to Week 96
Percentage of Participants With No Evidence of Disease Activity (NEDA)
From Week 24 to Week 96
Percentage of Participants With Impaired Symbol Digit Modalities Test (SDMT)
Baseline to Week 96
+2 more secondary outcomes

Study Arms (2)

Ublituximab + Oral Placebo

EXPERIMENTAL

Participants received ublituximab intravenous (IV) infusion, 150 milligrams (mg) over 4 hours (h) on Day 1 followed by 450 mg over 1 h on Days 15, 168, 336 and 504 (Week 72) along with the oral placebo tablet, once daily (QD) from Day 1 up to the last day of Week 95.

Biological: UblituximabDrug: Oral Placebo

Teriflunomide + IV Placebo

ACTIVE COMPARATOR

Participants received teriflunomide 14 mg tablet, orally, QD from Day 1 up to the last day of Week 95 along with the placebo IV infusion on Days 1, 15, 168, 336 and 504 (Week 72).

Drug: TeriflunomideDrug: IV Placebo

Interventions

UblituximabBIOLOGICAL

Administered as an IV infusion.

Also known as: TG-1101

Ublituximab + Oral Placebo

TeriflunomideDRUG

Film coated tablets administered orally.

Teriflunomide + IV Placebo

Oral PlaceboDRUG

Administered orally.

Ublituximab + Oral Placebo

IV PlaceboDRUG

Administered as an IV Infusion.

Teriflunomide + IV Placebo

Eligibility Criteria

Age18 Years - 55 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64)

You may qualify if:

Diagnosis of relapsing multiple sclerosis (RMS) (McDonald Criteria 2010)
Active disease
Expanded disability status scale (EDSS) 0 - 5.5 (inclusive) at screening

You may not qualify if:

Treatment with prior Anti-cluster of differentiate 20 (CD20) or other B cell directed treatment
Treatment with the following therapies at any time prior to randomization: alemtuzumab, natalizumab, teriflunomide, leflunomide and Stem cell transplantation
Diagnosed with primary progressive multiple sclerosis (PPMS)
Pregnant or nursing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

TG Therapeutics, Inc.lead