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Monoclonal Antibodies

Ublituximab for Multiple Sclerosis

Phase 3

Waitlist Available

Research Sponsored by TG Therapeutics, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

Participants who have had a confirmed multiple sclerosis (MS) relapse within the past 30 days prior to Week 1 Day 1 (W1D1). Following a relapse, participants must be neurologically stable for at least 30 days prior to screening or W1D1 of the OLE

Any significant or uncontrolled medical condition or treatment-emergent, clinically significant laboratory abnormality such as: Absolute neutrophil count < 1.5 x 10e3/µL, Hematocrit < 24%, Platelet count < 150,000 cell/mm^3, Hypogammaglobulinemia immunoglobulin G (IgG) < 4.0g/L, Active infection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to week 336

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial will test how safe and effective ublituximab is for treating relapsing multiple sclerosis over the long term.

Who is the study for?

This trial is for people with relapsing multiple sclerosis who completed prior ublituximab studies. They must be willing to use contraception and have no unstable disease activity, malignancies (except certain skin lesions), recent live vaccines, significant medical issues, or ongoing pregnancy. Those who started other MS treatments after previous studies are excluded.

What is being tested?

The study tests the long-term safety and effectiveness of a medication called Ublituximab in individuals with relapsing multiple sclerosis. Participants will receive this drug to see how well it continues to work over time and what side effects may occur with extended use.

What are the potential side effects?

While not specified here, common side effects of drugs like Ublituximab can include infusion reactions such as fever or chills, potential infections due to immune system changes, fatigue, headache, nausea, and possibly others based on individual health conditions.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I had an MS flare-up in the last month but have been stable for 30 days.

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I do not have any major health issues or abnormal blood test results.

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I have cancer, but not just skin cancer that was removed by surgery.

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My disease is currently not stable.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to week 336

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to week 336

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to week 336 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Annualized Relapse Rate (ARR)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Ublituximab InfusionsExperimental Treatment1 Intervention

RMS301/RMS302: All participants transferring from RMS301/RMS302 who sign consent for this study will receive an initial 4-hour infusion of 150 mg ublituximab on Week 1 (Day 1) followed by a 1-hour infusion of 450 mg ublituximab 14 days later Week 3 (Day 15). Subsequent infusions of ublituximab will be administered at 450 mg for 1-hour every 24 weeks from Weeks 24 to 312. RMS201E: All participants transferring from RMS201E who sign consent for this study will receive a 1-hour infusion of 450 mg ublituximab on Week 1 (Day 1) and subsequent infusions of ublituximab will be administered at 450 mg for 1-hour every 24 weeks from Weeks 24 to 312. For all participants (RMS301/RMS302/RMS201E), infusion treatment will continue for 312 weeks, or until physician or participant decision to withdraw from the study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ublituximab

2017

Completed Phase 3

~1490

0 / 4Eligibility criteria met