Ublituximab for Multiple Sclerosis

Recruiting at 65 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: TG Therapeutics, Inc.

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

The purpose of this study is to evaluate long-term safety and efficacy of ublituximab therapy in participants with relapsing multiple sclerosis (RMS).

Eligibility Criteria

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.

Inclusion Criteria

Female participants of child-bearing potential, and male partners must consent to use a medically acceptable method of contraception from consent, throughout the study period, and for 20 weeks after the last dose of ublituximab

Are able and willing to provide written informed consent (e.g., before the first infusion) and to comply with the study protocol

You must have finished participating in specific previous studies related to this trial.

Exclusion Criteria

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

You have started any new treatments or participated in other clinical trials after the specified study visits.

I have not received a live virus vaccine in the last 2 months.

Treatment Details

Interventions

• Ublituximab (Monoclonal Antibodies)

Trial Overview 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.

Participant Groups

Group I: Ublituximab Infusions Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

TG Therapeutics, Inc.

Lead Sponsor

Trials

41

Recruited

6,900+