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Clinical Trials in the USA / NCT05877963
Recruiting Phase 3

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

NCT05877963 · tracked via the Priya Life Science USA tracker
Sponsor
TG Therapeutics, Inc.
Phase
Phase 3
Started
2023-06-13
Last updated
2026-08-27

Condition(s) studied

Relapsing Multiple Sclerosis

Investigational drug(s) / intervention(s)

UblituximabPlacebo

Ublituximab: Administered as an intravenous (IV) infusion.

Placebo: IV infusion

Study 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

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (51)

FacilityCityRegionStatus
TG Therapeutics Investigational Trial Site Birmingham Alabama Recruiting
TG Therapeutics Investigational Trial Site Cullman Alabama Recruiting
TG Therapeutics Investigational Trial Site Orange California Recruiting
TG Investigational Site Fort Collins Colorado Recruiting
TG Therapeutics Investigational Trial Site Washington D.C. District of Columbia Recruiting
TG Therapeutics Investigational Trial Site Tampa Florida Recruiting
TG Therapeutics Investigational Trial Site Atlanta Georgia Recruiting
TG Therapeutics Investigational Trial Site Atlanta Georgia Recruiting
TG Therapeutics Investigational Trial Site Savannah Georgia Recruiting
TG Therapeutics Investigational Trial Site Chicago Illinois Recruiting
TG Therapeutics Investigational Trial Site Indianapolis Indiana Recruiting
TG Therapeutics Investigational Trial Site Iowa City Iowa Recruiting
TG Therapeutics Investigational Trial Site Overland Park Kansas Recruiting
TG Therapeutics Investigational Trial Site Overland Park Kansas Completed
TG Therapeutics Investigational Trial Site Lutherville Maryland Recruiting
TG Therapeutics Investigational Trial Site Boston Massachusetts Recruiting
TG Therapeutics Investigational Trial Site Boston Massachusetts Recruiting
TG Therapeutics Investigational Trial Site Foxborough Massachusetts Recruiting
TG Therapeutics Investigational Trial Site North Worcester Massachusetts Recruiting
TG Therapeutics Investigational Trial Site Wellesley Massachusetts Recruiting
TG Investigational Site Farmington Michigan Recruiting
TG Therapeutics Investigational Trial Site Golden Valley Minnesota Recruiting
TG Therapeutics Investigational Trial Site Plymouth Minnesota Recruiting
TG Therapeutics Investigational Trial Site St Louis Missouri Recruiting
TG Therapeutics Investigational Trial Site New York New York Recruiting
TG Therapeutics Investigational Trial Site New York New York Recruiting
TG Therapeutics Investigational Trial SiteCharlotte Charlotte North Carolina Recruiting
TG Therapeutics Investigational Trial Site Raleigh North Carolina Recruiting
TG Therapeutics Investigational Trial Site Cincinnati Ohio Recruiting
TG Therapeutics Investigational Trial Site Cleveland Ohio Recruiting
TG Therapeutics Investigational Trial Site Dayton Ohio Recruiting
TG Therapeutics Investigational Trial Site Oklahoma City Oklahoma Recruiting
TG Therapeutics Investigational Trial Site Greenville South Carolina Recruiting
TG Therapeutics Investigational Trial Site Knoxville Tennessee Recruiting
TG Therapeutics Investigational Trial Site Houston Texas Completed
TG Therapeutics Investigational Trial Site Salt Lake City Utah Recruiting
TG Therapeutics Investigational Trial Site Vienna Virginia Recruiting
TG Therapeutics Investigational Trial Site Kirkland Washington Recruiting
TG Therapeutics Investigational Trial Site Seattle Washington Recruiting
TG Therapeutics Investigational Trial Site Spokane Washington Recruiting

+ 11 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05877963 on ClinicalTrials.gov ↗ ← All trials in the USA