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NCT05877963PHASE3Recruiting

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

TG Therapeutics, Inc.

Start Date

6/13/2023

Completion Date

12/1/2027

Summary

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. The study consists of 3 parts: Part A is single-armed and open-label, Part B is randomized, double-blind, placebo-controlled, and Part C is single-armed and open-label.

Eligibility Criteria

Age Range: 18 years to 65 years

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.

Interventions

BIOLOGICAL

Ublituximab

DRUG

Placebo

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Conditions

Relapsing Multiple Sclerosis

Locations

TG Therapeutics Investigational Trial Site

Birmingham, Alabama 35209

United States

TG Therapeutics Investigational Trial Site

Cullman, Alabama 35058

United States

TG Therapeutics Investigational Trial Site

Orange, California 92697

United States

TG Investigational Site

Fort Collins, Colorado 80528

United States

TG Therapeutics Investigational Trial Site

Washington D.C., District of Columbia 20007

United States

TG Therapeutics Investigational Trial Site

Tampa, Florida 33612

United States

TG Therapeutics Investigational Trial Site

Savannah, Georgia 31406

United States

TG Therapeutics Investigational Trial Site

Chicago, Illinois 60612

United States

TG Therapeutics Investigational Trial Site

Indianapolis, Indiana 46256

United States

TG Therapeutics Investigational Trial Site

Iowa City, Iowa 52242

United States

TG Therapeutics Investigational Trial Site

Overland Park, Kansas 66212

United States

TG Therapeutics Investigational Trial Site

Lutherville, Maryland 21093

United States

TG Therapeutics Investigational Trial Site

Boston, Massachusetts 00002

United States

TG Therapeutics Investigational Trial Site

Foxborough, Massachusetts 02035

United States

TG Therapeutics Investigational Trial Site

North Worcester, Massachusetts 01655

United States

TG Therapeutics Investigational Trial Site

Wellesley, Massachusetts 02481uni

United States

TG Investigational Site

Farmington, Michigan 48334

United States

TG Therapeutics Investigational Trial Site

Golden Valley, Minnesota 55422

United States

TG Therapeutics Investigational Trial Site

Plymouth, Minnesota 55446

United States

TG Therapeutics Investigational Trial Site

St Louis, Missouri 63131

United States

TG Therapeutics Investigational Trial Site

New York, New York 10025

United States

TG Therapeutics Investigational Trial Site

New York, New York 11021

United States

TG Therapeutics Investigational Trial SiteCharlotte

Charlotte, North Carolina 28204

United States

TG Therapeutics Investigational Trial Site

Raleigh, North Carolina 27607

United States

TG Therapeutics Investigational Trial Site

Cleveland, Ohio 44195

United States

TG Therapeutics Investigational Trial Site

Dayton, Ohio 45417

United States

TG Therapeutics Investigational Trial Site

Oklahoma City, Oklahoma 73104

United States

TG Therapeutics Investigational Trial Site

Greenville, South Carolina 29605

United States

TG Therapeutics Investigational Trial Site

Knoxville, Tennessee 37922

United States

TG Therapeutics Investigational Trial Site

Houston, Texas 77030

United States

TG Therapeutics Investigational Trial Site

Salt Lake City, Utah 84103

United States

TG Therapeutics Investigational Trial Site

Vienna, Virginia 22182

United States

TG Therapeutics Investigational Trial Site

Kirkland, Washington 98034

United States

TG Therapeutics Investigational Trial Site

Seattle, Washington 98109

United States

TG Therapeutics Investigational Trial Site

Spokane, Washington 99208

United States

TG Therapeutics Investigational Trial Site

Milwaukee, Wisconsin 53226

United States

TG Therapeutics Investigational Trial Site

Bydgoszcz,

Poland

TG Therapeutics Investigational Trial Site

Katowice, 40-555

Poland

TG Therapeutics Investigational Trial Site

Katowice,

Poland

TG Therapeutics Investigational Trial Site

Kielce,

Poland

TG Therapeutics Investigational Trial Site

Krakow, 31-826

Poland

TG Therapeutics Investigational Trial Site

Lodz,

Poland

TG Therapeutics Investigational Trial Site

Olsztyn, 10-561

Poland

TG Therapeutics Investigational Trial Site

Poznan,

Poland

TG Therapeutics Investigational Trial Site

Warsaw, 04-141

Poland

TG Therapeutics Investigational Trial Site

Zabrze,

Poland

TG Therapeutics Investigational Trial Site

Żory, 44-240

Poland