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RecruitingPhase 3NCT07211633

A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, Radiological and Clinical Effects of Subcutaneous Ublituximab in Participants With Relapsing Multiple Sclerosis (RMS)

A Phase 3, Non-Inferiority, Randomized, Open-Label, Parallel Group, Multicenter Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, Radiological and Clinical Effects of Subcutaneous Ublituximab Versus Intravenous Ublituximab in Patients With Multiple Sclerosis

Sponsor

TG Therapeutics, Inc.

Enrollment

360 participants

Start Date

Jul 9, 2025

Study Type

INTERVENTIONAL

Conditions

Relapsing Multiple Sclerosis

Summary

The purpose of this study is to assess the pharmacokinetics of ublituximab when administered subcutaneously (SC) compared to intravenous (IV) administration in participants with RMS.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new way to deliver the MS treatment Ublituximab — by injection under the skin (subcutaneous) instead of intravenously — in people with relapsing multiple sclerosis (MS), to make treatment more convenient while assessing safety and effectiveness. **You may be eligible if...** - You have been diagnosed with relapsing MS (per 2017 McDonald criteria) - Your disability level is no higher than EDSS 5.5 (you are still able to walk) - Your condition has been neurologically stable for at least 30 days - If you are a woman who could become pregnant, you are willing to use effective contraception during and for 6 months after treatment **You may NOT be eligible if...** - You have primary-progressive MS or inactive secondary-progressive MS - You have another active immune system disease beyond MS, or an immunodeficiency - You have severely reduced bone marrow function or very low blood counts - You have previously received any anti-CD20 therapy (such as Ocrelizumab or Rituximab) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALUblituximab

Administered as an IV infusion.

BIOLOGICALUblituximab

Administered as an SC injection.

Locations(42)

TG Therapeutics Investigational Trial Site

Banja Luka, Bosnia and Herzegovina

TG Therapeutics Investigational Trial Site

Bihać, Bosnia and Herzegovina

TG Therapeutics Investigational Trial Site

Mostar, Bosnia and Herzegovina

TG Therapeutics Investigational Trial Site

Saravejo, Bosnia and Herzegovina

TG Therapeutics Investigational Trial Site

Pleven, Bulgaria

TG Therapeutics Investigational Trial Site

Plovdiv, Bulgaria

TG Therapeutics Investigational Trial Site

Sofia, Bulgaria

TG Therapeutics Investigational Trial Site

Veliko Tarnovo, Bulgaria

TG Therapeutics Investigational Trial Site

Varaždin, Croatia

TG Therapeutics Investigational Trial Site

Zagreb, Croatia

TG Therapeutics Investigational Trial Site

Brno, Czechia

TG Therapeutics Investigational Trial Site

Hradec Králové, Czechia

TG Therapeutics Investigational Trial Site

Jihlava, Czechia

TG Therapeutics Investigational Trial Site

Ostrava, Czechia

TG Therapeutics Investigational Trial Site

Pardubice, Czechia

TG Therapeutics Investigational Trial Site

Zlín, Czechia

TG Therapeutics Investigational Trial Site

Tbilisi, Georgia

TG Therapeutics Investigational Trial Site

Tbilisi, Georgia

TG Therapeutics Investigational Trial Site

Tbilisi, Georgia

TG Therapeutics Investigational Trial Site

Tbilisi, Georgia

TG Therapeutics Investigational Trial Site

Tbilisi, Georgia

TG Therapeutics Investigational Trial Site

Tbilisi, Georgia

TG Therapeutics Investigational Trial Site

Tbilisi, Georgia

TG Therapeutics Investigational Trial Site

Tbilisi, Georgia

TG Therapeutics Investigational Trial Site

Budapest, Hungary

TG Therapeutics Investigational Trial Site

Budapest, Hungary

TG Therapeutics Investigational Trial Site

Kaposvár, Hungary

TG Therapeutics Investigational Trial Site

Kistarsca, Hungary

TG Therapeutics Investigational Trial Site

Pécs, Hungary

TG Therapeutics Investigational Trial Site

Shtip, North Macedonia

TG Therapeutics Investigational Trial Site

Skopje, North Macedonia

TG Therapeutics Investigational Trial Site

Cherkasy, Ukraine

TG Therapeutics Investigational Trial Site

Ivano-Frankivsk, Ukraine

TG Therapeutics Investigational Trial Site

Ivano-Frankivsk, Ukraine

TG Therapeutics Investigational Trial Site

Ivano-Frankivsk, Ukraine

TG Therapeutics Investigational Trial Site

Kyiv, Ukraine

TG Therapeutics Investigational Trial Site

Kyiv, Ukraine

TG Therapeutics Investigational Trial Site

Lviv, Ukraine

TG Therapeutics Investigational Trial Site

Lviv, Ukraine

TG Therapeutics Investigational Trial Site

Ternopil, Ukraine

TG Therapeutics Investigational Trial Site

Vinnytsia, Ukraine

TG Therapeutics Investigational Trial Site

Vinnytsia, Ukraine

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NCT07211633

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