Evaluating a modified treatment regimen of ublituximab for relapsing multiple sclerosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 3b clinical trial aims to assess the safety and efficacy of a modified regimen of ublituximab in patients with relapsing multiple sclerosis (RMS). The study is divided into two parts: Part A is a single-arm, open-label segment, while Part B is a randomized, double-blind, placebo-controlled segment. The primary outcome measures include the evaluation of T1 Gadolinium-enhancing lesions and pharmacokinetics of the treatment. Participants will be monitored for their response to the modified treatment regimen over the course of the study.

Why it matters

Who can join: the full rules

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 prior to consent and meet the washout requirements.
* Expanded Disability Status Scale (EDSS) score ≤ 5.5 at screening.
* Neurologically stable for \> 30 days prior to first dose of ublituximab.
* Female participants of childbearing potential must consent to use a medically acceptable method of contraception from consent, throughout the study period, and for 6 months after the last dose of ublituximab.
* Part C: participants currently treated with an anti-CD20 agent for at least 6 months and meet the washout requirements prior to W1D1.
* Part C: Discontinuation of current anti-CD20 must be due to suboptimal experience

Exclusion Criteria:

* History of any serious 3 Infusion Related Reaction (IRR) on prior anti-CD20 therapy.
* Primary-progressive multiple sclerosis (PPMS) or inactive Secondary Progressive MS (SPMS).
* Active chronic (or stable but treated with immune therapy) disease of the immune system other than MS (e.g., rheumatoid arthritis, scleroderma, Sjögren's syndrome, Crohn's disease, ulcerative colitis, etc.) or immunodeficiency syndrome (hereditary immune deficiency, drug-induced immune deficiency, etc.).
* Current evidence or known history of clinically significant infection, including: chronic, recurrent, or ongoing active viral, bacterial, or fungal infectious disease requiring long term systemic treatment such as, but not limited to chronic urinary tract infection, chronic pulmonary infection with bronchiectasis, tuberculosis, or active hepatitis C virus (HCV).
* Previous serious opportunistic or atypical infection.
* Evidence of chronic active or history of hepatitis B virus (HBV) infection as evidenced by a detectable hepatitis B surface antigen (HBsAg), or positive hepatitis B core antibody (HBcAb), or chronic hepatitis C infection. Participants with positive hepatitis C virus antibody (HCV Ab) are eligible only if polymerase chain reaction (PCR) is negative for HCV ribonucleic acid (RNA).
* History or evidence (clinical, radiological, or biomarker) of suspected or confirmed progressive multifocal leukoencephalopathy (PML).
* Receipt of any live or live-attenuated vaccines (including vaccines for varicella-zoster virus or measles) within 4 weeks prior to first study drug administration.
* Participants requiring treatment with intravenous immune globulin (IVIG) for decreased immunoglobulins within the 12 months prior to W1D1.
* Any active malignancies other than adequately treated basal, squamous cell or in situ carcinoma.
* Participants who have ever received ublituximab, alemtuzumab, cyclophosphamide, mitoxantrone, cladribine, or daclizumab (including for non-MS indications).

Note: Other Inclusion/Exclusion criteria may apply.

Where it's running

• TG Therapeutics Investigational Trial Site
  Birmingham, Alabama, United States Recruiting
• TG Therapeutics Investigational Trial Site
  Cullman, Alabama, United States Recruiting
• TG Therapeutics Investigational Trial Site
  Orange, California, United States Recruiting
• TG Investigational Site
  Fort Collins, Colorado, United States Recruiting
• TG Therapeutics Investigational Trial Site
  Washington D.C., District of Columbia, United States Recruiting
• TG Therapeutics Investigational Trial Site
  Tampa, Florida, United States Recruiting

+1 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: TG Therapeutics Clinical Support Team
• Email: clinicalsupport@tgtxinc.com
• Phone: 1-877-575-8489

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Switching to ublituximab for ocrelizumab wearing-off in multiple sclerosis

  This pilot will try switching people with relapsing MS who experience symptom 'wearing off' on ocrelizumab to ublituximab to see if their symptoms improve or return later.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.