Study to Evaluate Safety, Efficacy and Pharmacokinetics (PK) of a Modified Regimen of Ublituximab
NCT ID: NCT05877963
Last Updated: 2025-11-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
800 participants
INTERVENTIONAL
2023-06-13
2026-09-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Part A: Ublituximab
Participants will receive a modified regimen of ublituximab including infusions on Day 1 of Week 1 (W1D1), Day 15, if applicable, and ublituximab 450 milligrams (mg) infusion at Week 24.
Ublituximab
Administered as an intravenous (IV) infusion.
Part B: Ublituximab /Placebo (Treatment Arm A)
Participants will receive 600 mg of ublituximab on W1D1 followed by a placebo infusion on Day 15 and 450 mg ublituximab infusion at Week 24.
Ublituximab
Administered as an intravenous (IV) infusion.
Placebo
IV infusion
Part B: Ublituximab (Treatment Arm B)
Participants will receive 150 mg of ublituximab on W1D1 followed by 450 mg on Day 15 and at Week 24.
Ublituximab
Administered as an intravenous (IV) infusion.
Interventions
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Ublituximab
Administered as an intravenous (IV) infusion.
Placebo
IV infusion
Other Intervention Names
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Eligibility Criteria
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Inclusion 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.
Exclusion Criteria
* 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).
18 Years
65 Years
ALL
No
Sponsors
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TG Therapeutics, Inc.
INDUSTRY
Responsible Party
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Locations
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TG Therapeutics Investigational Trial Site
Birmingham, Alabama, United States
TG Therapeutics Investigational Trial Site
Cullman, Alabama, United States
TG Therapeutics Investigational Trial Site
Orange, California, United States
TG Investigational Site
Fort Collins, Colorado, United States
TG Therapeutics Investigational Trial Site
Washington D.C., District of Columbia, United States
TG Therapeutics Investigational Trial Site
Tampa, Florida, United States
TG Therapeutics Investigational Trial Site
Chicago, Illinois, United States
TG Therapeutics Investigational Trial Site
Indianapolis, Indiana, United States
TG Therapeutics Investigational Trial Site
Iowa City, Iowa, United States
TG Therapeutics Investigational Trial Site
Overland Park, Kansas, United States
TG Therapeutics Investigational Trial Site
Lutherville, Maryland, United States
TG Therapeutics Investigational Trial Site
Boston, Massachusetts, United States
TG Therapeutics Investigational Trial Site
Foxborough, Massachusetts, United States
TG Therapeutics Investigational Trial Site
North Worcester, Massachusetts, United States
TG Therapeutics Investigational Trial Site
Wellesley, Massachusetts, United States
TG Investigational Site
Farmington, Michigan, United States
TG Therapeutics Investigational Trial Site
Golden Valley, Minnesota, United States
TG Therapeutics Investigational Trial Site
Plymouth, Minnesota, United States
TG Therapeutics Investigational Trial Site
St Louis, Missouri, United States
TG Therapeutics Investigational Trial Site
New York, New York, United States
TG Therapeutics Investigational Trial Site
New York, New York, United States
TG Therapeutics Investigational Trial SiteCharlotte
Charlotte, North Carolina, United States
TG Therapeutics Investigational Trial Site
Raleigh, North Carolina, United States
TG Therapeutics Investigational Trial Site
Cleveland, Ohio, United States
TG Therapeutics Investigational Trial Site
Dayton, Ohio, United States
TG Therapeutics Investigational Trial Site
Oklahoma City, Oklahoma, United States
TG Therapeutics Investigational Trial Site
Greenville, South Carolina, United States
TG Therapeutics Investigational Trial Site
Knoxville, Tennessee, United States
TG Therapeutics Investigational Trial Site
Waco, Texas, United States
TG Therapeutics Investigational Trial Site
Salt Lake City, Utah, United States
TG Therapeutics Investigational Trial Site
Vienna, Virginia, United States
TG Therapeutics Investigational Trial Site
Kirkland, Washington, United States
TG Therapeutics Investigational Trial Site
Seattle, Washington, United States
TG Therapeutics Investigational Trial Site
Spokane, Washington, United States
TG Therapeutics Investigational Trial Site
Milwaukee, Wisconsin, United States
TG Therapeutics Investigational Trial Site
Bydgoszcz, , Poland
TG Therapeutics Investigational Trial Site
Katowice, , Poland
TG Therapeutics Investigational Trial Site
Katowice, , Poland
TG Therapeutics Investigational Trial Site
Kielce, , Poland
TG Therapeutics Investigational Trial Site
Krakow, , Poland
TG Therapeutics Investigational Trial Site
Lodz, , Poland
TG Therapeutics Investigational Trial Site
Olsztyn, , Poland
TG Therapeutics Investigational Trial Site
Poznan, , Poland
TG Therapeutics Investigational Trial Site
Warsaw, , Poland
TG Therapeutics Investigational Trial Site
Zabrze, , Poland
TG Therapeutics Investigational Trial Site
Żory, , Poland
Countries
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Central Contacts
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Other Identifiers
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2024-519284-18-00
Identifier Type: OTHER
Identifier Source: secondary_id
TG1101-RMS401
Identifier Type: -
Identifier Source: org_study_id
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