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A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, Radiological and Clinical Effects of Subcutaneous Ublituximab in Participants With Relapsing Multiple Sclerosis (RMS)
Sponsor: TG Therapeutics, Inc.
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
360
Start Date
2025-07-09
Completion Date
2028-12-31
Last Updated
2026-04-03
Healthy Volunteers
No
Conditions
Interventions
Ublituximab
Administered as an IV infusion.
Ublituximab
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