Modified Ublituximab for Relapsing Multiple Sclerosis

Study to Evaluate Safety, Efficacy and Pharmacokinetics (PK) of a Modified Regimen of Ublituximab

Recruiting Phase 3 Interventional Study
Relapsing Multiple Sclerosis
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 – 65
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
800 (estimated)
Sponsor
TG Therapeutics, Inc. · Industry
Who this trial is looking for

This trial is looking for people with relapsing multiple sclerosis. Participants will receive a modified treatment of ublituximab and help researchers understand its effectiveness and safety.

Are You a Good Fit for This Trial?
Rules you out Active malignancies

You may be able to join if

  • I have been diagnosed with relapsing multiple sclerosis.
  • I am neurologically stable for more than 30 days before starting treatment.
  • I have a disability status score of 5.5 or less.
  • I am either new to treatment or have stopped my previous treatment.
  • I will use reliable contraception if I am a woman of childbearing potential.
  • I have been on anti-CD20 treatment for at least 6 months and need to stop it due to unsatisfactory results.

You may not be able to join if

  • I have had a serious reaction to anti-CD20 therapy.
  • I have primary-progressive multiple sclerosis or inactive secondary progressive MS.
  • I have ongoing significant infections that require long-term treatment.
  • I have a history of certain serious infections.
  • I have chronic active hepatitis B or C.
  • I have ever had progressive multifocal leukoencephalopathy.
  • I have received live vaccines within 4 weeks before starting the study.
  • I am currently being treated with intravenous immune globulin.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial
The primary purpose of this phase 3b study is to assess the efficacy of a modified regimen of ublituximab in participants with relapsing multiple sclerosis (RMS) as measured by T1 Gadolinium (Gd)-enhancing lesions in Part A; PK in Part B along with efficacy of ublituximab as measured by T1 Gd-enhancing lesions in participants who had a suboptimal experience on prior anti-CD20 therapy in Part C. Th…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Diagnosis of RMS (2017 Revised McDonald criteria). * Participants must meet one of the following prior treatment definitions: 1. Participants naïve to treatment. 2. Participants previously treated with a disease modifying therapy (DMT) who have discontinued treatment prio…
Contacts

TG Therapeutics Clinical Support Team

1-877-575-8489

clinicalsupport@tgtxinc.com

CONTACT