Ublituximab for Multiple Sclerosis

Overseen By Ziyun Research Program Coordinator

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Johns Hopkins University

Must be taking: Ocrelizumab

Must not be taking: Rituximab, Ofatumumab

Disqualifiers: Lymphopenia, Neutrophils <1.5X10E9/L, Malignancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

The proposed study is a pilot study of ublituximab involving people with multiple sclerosis (MS) who are experiencing a "wearing off" phenomenon (return or worsening of MS-related symptoms) while being treated with ocrelizumab, and exploring whether switching to ublituzimab can resolve, improve or delay this phenomenon.

Who Is on the Research Team?

Shiv Saidha, MD

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

This trial is for people with Multiple Sclerosis who notice their symptoms getting worse or coming back while on Ocrelizumab. It's to see if switching to Ublituximab helps.

Inclusion Criteria

I am between 18 and 65 years old.

I have been on ocrelizumab treatment for at least a year.

I am willing to continue treatment with ocrelizumab or ublituximab.

Exclusion Criteria

Infection history as specified

I know my hepatitis status.

Positive tuberculosis screening

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants switch from Ocrelizumab to Ublituximab or continue with Ocrelizumab, receiving infusions every 6 months for at least 2 doses

12 months

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Ublituximab

Trial Overview

The study tests whether Ublituximab can help MS patients whose symptoms return despite taking Ocrelizumab. It's a pilot study, meaning it's an early test of this idea.

How Is the Trial Designed?

Group I: Ublituximab Experimental Treatment 1 Intervention

Participants in this arm will switch from Ocrelizumab to receive Ublituximab administered intravenously (IV) as cumulative dose of 450-milligram (mg) infusions every 6 months for at least 2 doses.

Group II: Ocrelizumab Active Control 1 Intervention

Participants in this arm will continue to receive Ocrelizumab administered intravenously (IV) as 600-milligram (mg) infusions every 6 months for at least a further 2 doses.

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

TG Therapeutics, Inc.

Industry Sponsor

Trials

41

Recruited

6,900+