NCT02738775|CompletedPhase 2ResultsDMC

Phase IIa Study of Ublituximab in Participants With Relapsing Forms of Multiple Sclerosis

A Placebo-Controlled Multi-Center Phase IIa Dose Finding Study of Ublituximab, a Third-Generation Anti-CD20 Monoclonal Antibody, in Patients With Relapsing Forms of Multiple Sclerosis.

TG Therapeutics, Inc.ClinicalTrials.gov

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1 other identifier

TG1101-RMS-201

Study Type

interventional

Target

Locations

1 country

Sites

Timeline

RegisteredApr 2016

StartedMay 2016

CompletionAug 2018

Brief Summary

This study evaluates the use of single agent ublituximab, a novel monoclonal antibody, in participants 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 multiple-sclerosis

Timeline

Completed

Started May 2016

Geographic Reach

1 country

12 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

2.2 years study duration

First Submitted

Initial submission to the registry

April 10, 2016

Completed

4 days until next milestone

First Posted

Study publicly available on registry

April 14, 2016

Completed

1 month until next milestone

Study Start

First participant enrolled

May 27, 2016

Completed

1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 27, 2017

Completed

11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 13, 2018

Completed

2.9 years until next milestone

Results Posted

Study results publicly available

July 15, 2021

Completed

Last Updated

July 15, 2021

Status Verified

June 1, 2021

Enrollment Period

1.3 years

First QC Date

April 10, 2016

Results QC Date

June 22, 2021

Last Update Submit

June 22, 2021

Conditions

Multiple Sclerosis

Keywords

multiple sclerosis

Outcome Measures

Primary Outcomes (1)

Responder Rate of B-Cell Depletion at Week 4
Responders Rate is defined as percentage of participants with greater than or equal to (≥) 95% reduction of B cells (cluster of differentiation 19 positive \[CD19+\] cells) within 2 weeks after the second infusion (Day 15).
Week 4

Secondary Outcomes (12)

Number of New Gadolinium (Gd)-Enhancing T1 Lesions at Weeks 24 and 48
Weeks 24 and 48
Number of New or Enlarging T2 Lesions at Weeks 24 and 48
Weeks 24 and 48
Annualized Relapse Rate (ARR)
Week 48
Relapse Rate Reduction (RRR)
Baseline to Week 48
Percentage of Relapse Free Participants
Week 48
+7 more secondary outcomes

Study Arms (6)

Cohort 1

EXPERIMENTAL

Participant received intravenous (IV) infusion of ublituximab 150 milligrams (mg)/4 hour (hr) on Day 1, 450 mg/3 hr on Day 15 and 450 mg/1.5 hr on Week 24. Some participants initially received placebo IV infusion /4 hr on Day 1 and /3 hr on Day 15 before receiving ublituximab.

Biological: UblituximabDrug: Placebo

Cohort 2

EXPERIMENTAL

Participant received IV infusion of ublituximab 150 mg/4 hr on Day 1, 450 mg/1.5 hr on Day 15 and 450 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /4 hr on Day 1 and /1.5 hr on Day 15 before receiving ublituximab.

Biological: UblituximabDrug: Placebo

Cohort 3

EXPERIMENTAL

Participant received IV infusion of ublituximab 150 mg/4 hr on Day 1, 450 mg/1 hr on Day 15 and 600 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /4 hr on Day 1 and /1 hr on Day 15 before receiving ublituximab.

Biological: UblituximabDrug: Placebo

Cohort 4

EXPERIMENTAL

Participant received IV infusion of ublituximab 150 mg/3 hr on Day 1, 600 mg/1 hr on Day 15 and 600 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /3 hr on Day 1 and /1 hr on Day 15 before receiving ublituximab.

Biological: UblituximabDrug: Placebo

Cohort 5

EXPERIMENTAL

Participant received IV infusion of ublituximab 150 mg/2 hr on Day 1, 600 mg/1 hr on Day 15 and 600 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /2 hr on Day 1 and /1 hr on Day 15 before receiving ublituximab.

Biological: UblituximabDrug: Placebo

Cohort 6

EXPERIMENTAL

Participant received IV infusion of ublituximab 150 mg/1 hr on Day 1, 600 mg/1 hr on Day 15 and 600 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /1 hr on Day 1 and /1 hr on Day 15 before receiving ublituximab.

Biological: UblituximabDrug: Placebo

Interventions

UblituximabBIOLOGICAL

Administered as an IV infusion.

Also known as: TG-1101

Cohort 1Cohort 2Cohort 3Cohort 4Cohort 5Cohort 6

PlaceboDRUG

Cohort 1Cohort 2Cohort 3Cohort 4Cohort 5Cohort 6

Eligibility Criteria

Age18 Years - 55 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64)

You may qualify if:

Diagnosis of relapsing multiple sclerosis
Active disease
Greater than or equal to (≥) 2 relapses in prior 2 years or 1 relapse in the year prior to screening and/or ≥1 gadolinium (Gd) enhancing lesion

You may not qualify if:

Treatment with anti-cluster of differentiation 20 (CD20) monoclonal antibody within the last 12 months
Treatment with alemtuzumab within the last 12 months
Pregnant or nursing mothers

Contact the study team to confirm eligibility.