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Clinical Trials in Czechia / NCT07211633
Active, not recruiting Phase 3

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

NCT07211633 · tracked via the Priya Life Science Czechia tracker
Phase
Phase 3
Started
2025-07-09
Last updated
2026-09-21

Condition(s) studied

Relapsing Multiple Sclerosis

Investigational drug(s) / intervention(s)

Ublituximab →Ublituximab →

Ublituximab: Administered as an IV infusion.

Ublituximab: Administered as an SC injection.

Study 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

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria: 1. Diagnosis of RMS (2017 Revised McDonald criteria). 2. Expanded Disability Status Scale (EDSS) score ≤ 5.5 at screening. 3. Neurologically stable for \> 30 days prior to Screening and Day 1. 4. Female participants of childbearing potential must consent to use a highly effective method of contraception from consent and for 6 months after the last dose of ublituximab. Exclusion Criteria: 1. Primary-progressive Multiple Sclerosis (PPMS) or inactive Secondary Progressive Multiple Sclerosis (SPMS). 2. Active chronic disease of the immune system other than MS or immunodeficiency syndrome. 3. Participants with significantly impaired bone marrow function or significant leukopenia or thrombocytopenia. 4. Participants who previously received anti-CD20 therapy at any time; any approved therapy to treat MS within 5 half-lives of the medication prior to screening. Note: Other Inclusion/Exclusion criteria may apply.

Primary outcome measure(s)

Trial sites (48)

FacilityCityRegionStatus
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 Tulza 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 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 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 Kragujevac Serbia
TG Therapeutics Investigational Trial Site Niš Serbia
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

+ 8 more sites — see the full list on the official registry below.

Other trials for the same condition

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 NCT07211633 on ClinicalTrials.gov ↗ ← All trials in Czechia