Actively Recruiting

Phase 3
Age: 18Years - 65Years
All Genders
NCT07211633

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

Led by TG Therapeutics, Inc. · Updated on 2026-04-03

360

Participants Needed

42

Research Sites

181 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of Relapsing Multiple Sclerosis according to 2017 Revised McDonald criteria
  • Expanded Disability Status Scale (EDSS) score of 5.5 or less at screening
  • Neurologically stable for more than 30 days prior to screening and Day 1
  • Female participants of childbearing potential must agree to use highly effective contraception from consent through 6 months after last dose of ublituximab
Not Eligible

You will not qualify if you...

  • Primary-progressive Multiple Sclerosis (PPMS) or inactive Secondary Progressive Multiple Sclerosis (SPMS)
  • Active chronic immune system disease other than MS or immunodeficiency syndrome
  • Significant bone marrow impairment or significant leukopenia or thrombocytopenia
  • Previous treatment with anti-CD20 therapy at any time
  • Use of any approved MS therapy within 5 half-lives prior to screening
  • Other inclusion/exclusion criteria may apply

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 42 locations

1

TG Therapeutics Investigational Trial Site

Banja Luka, Bosnia and Herzegovina, 78000

Actively Recruiting

2

TG Therapeutics Investigational Trial Site

Bihać, Bosnia and Herzegovina, 77000

Actively Recruiting

3

TG Therapeutics Investigational Trial Site

Mostar, Bosnia and Herzegovina, 71000

Actively Recruiting

4

TG Therapeutics Investigational Trial Site

Saravejo, Bosnia and Herzegovina, 71000

Actively Recruiting

5

TG Therapeutics Investigational Trial Site

Pleven, Bulgaria, 5800

Actively Recruiting

6

TG Therapeutics Investigational Trial Site

Plovdiv, Bulgaria, 4000

Actively Recruiting

7

TG Therapeutics Investigational Trial Site

Sofia, Bulgaria, 1000

Actively Recruiting

8

TG Therapeutics Investigational Trial Site

Veliko Tarnovo, Bulgaria, 5000

Actively Recruiting

9

TG Therapeutics Investigational Trial Site

Varaždin, Croatia, 42000

Actively Recruiting

10

TG Therapeutics Investigational Trial Site

Zagreb, Croatia, 10000

Actively Recruiting

11

TG Therapeutics Investigational Trial Site

Brno, Czechia, 65691

Actively Recruiting

12

TG Therapeutics Investigational Trial Site

Hradec Králové, Czechia, 50005

Actively Recruiting

13

TG Therapeutics Investigational Trial Site

Jihlava, Czechia, 58601

Actively Recruiting

14

TG Therapeutics Investigational Trial Site

Ostrava, Czechia, 70300

Actively Recruiting

15

TG Therapeutics Investigational Trial Site

Pardubice, Czechia, 53002

Actively Recruiting

16

TG Therapeutics Investigational Trial Site

Zlín, Czechia, 76275

Actively Recruiting

17

TG Therapeutics Investigational Trial Site

Tbilisi, Georgia, 0112

Actively Recruiting

18

TG Therapeutics Investigational Trial Site

Tbilisi, Georgia, 0114

Actively Recruiting

19

TG Therapeutics Investigational Trial Site

Tbilisi, Georgia, 0159

Actively Recruiting

20

TG Therapeutics Investigational Trial Site

Tbilisi, Georgia, 0172

Actively Recruiting

21

TG Therapeutics Investigational Trial Site

Tbilisi, Georgia, 0178

Actively Recruiting

22

TG Therapeutics Investigational Trial Site

Tbilisi, Georgia, 0179

Actively Recruiting

23

TG Therapeutics Investigational Trial Site

Tbilisi, Georgia, 0180

Actively Recruiting

24

TG Therapeutics Investigational Trial Site

Tbilisi, Georgia, 3700

Actively Recruiting

25

TG Therapeutics Investigational Trial Site

Budapest, Hungary, H-1033

Actively Recruiting

26

TG Therapeutics Investigational Trial Site

Budapest, Hungary, H-1145

Actively Recruiting

27

TG Therapeutics Investigational Trial Site

Kaposvár, Hungary, H-7400

Actively Recruiting

28

TG Therapeutics Investigational Trial Site

Kistarsca, Hungary, H-2143

Actively Recruiting

29

TG Therapeutics Investigational Trial Site

Pécs, Hungary, H-7623

Actively Recruiting

30

TG Therapeutics Investigational Trial Site

Shtip, North Macedonia, 7240

Actively Recruiting

31

TG Therapeutics Investigational Trial Site

Skopje, North Macedonia, 1000

Actively Recruiting

32

TG Therapeutics Investigational Trial Site

Cherkasy, Ukraine, 14029

Actively Recruiting

33

TG Therapeutics Investigational Trial Site

Ivano-Frankivsk, Ukraine, 76000

Actively Recruiting

34

TG Therapeutics Investigational Trial Site

Ivano-Frankivsk, Ukraine, 76018

Actively Recruiting

35

TG Therapeutics Investigational Trial Site

Ivano-Frankivsk, Ukraine, 76493

Actively Recruiting

36

TG Therapeutics Investigational Trial Site

Kyiv, Ukraine, 03037

Actively Recruiting

37

TG Therapeutics Investigational Trial Site

Kyiv, Ukraine, 03115

Actively Recruiting

38

TG Therapeutics Investigational Trial Site

Lviv, Ukraine, 79000

Actively Recruiting

39

TG Therapeutics Investigational Trial Site

Lviv, Ukraine, 79010

Actively Recruiting

40

TG Therapeutics Investigational Trial Site

Ternopil, Ukraine, 46027

Actively Recruiting

41

TG Therapeutics Investigational Trial Site

Vinnytsia, Ukraine, 21002

Actively Recruiting

42

TG Therapeutics Investigational Trial Site

Vinnytsia, Ukraine, 21009

Actively Recruiting

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Research Team

T

TG Therapeutics Clinical Support Team

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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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) | DecenTrialz