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
Status: Recruiting
Location: See all (34) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:
• Diagnosis of RMS (2017 Revised McDonald criteria).
• Expanded Disability Status Scale (EDSS) score ≤ 5.5 at screening.
• Neurologically stable for \> 30 days prior to Screening and Day 1.
• Female participants of childbearing potential must consent to use an effective method of contraception from consent and for 6 months after the last dose of ublituximab.
Locations
Other Locations
Bosnia and Herzegovina
TG Therapeutics Investigational Trial Site
RECRUITING
Banja Luka
TG Therapeutics Investigational Trial Site
RECRUITING
Bihać
TG Therapeutics Investigational Trial Site
RECRUITING
Mostar
TG Therapeutics Investigational Trial Site
RECRUITING
Saravejo
Bulgaria
TG Therapeutics Investigational Trial Site
RECRUITING
Pleven
TG Therapeutics Investigational Trial Site
RECRUITING
Plovdiv
TG Therapeutics Investigational Trial Site
RECRUITING
Sofia
TG Therapeutics Investigational Trial Site
RECRUITING
Veliko Tarnovo
Croatia
TG Therapeutics Investigational Trial Site
RECRUITING
Varaždin
TG Therapeutics Investigational Trial Site
RECRUITING
Zagreb
Georgia
TG Therapeutics Investigational Trial Site
RECRUITING
Tbilisi
TG Therapeutics Investigational Trial Site
RECRUITING
Tbilisi
TG Therapeutics Investigational Trial Site
RECRUITING
Tbilisi
TG Therapeutics Investigational Trial Site
RECRUITING
Tbilisi
TG Therapeutics Investigational Trial Site
RECRUITING
Tbilisi
TG Therapeutics Investigational Trial Site
RECRUITING
Tbilisi
TG Therapeutics Investigational Trial Site
RECRUITING
Tbilisi
TG Therapeutics Investigational Trial Site
RECRUITING
Tbilisi
Hungary
TG Therapeutics Investigational Trial Site
RECRUITING
Budapest
TG Therapeutics Investigational Trial Site
RECRUITING
Budapest
TG Therapeutics Investigational Trial Site
RECRUITING
Kaposvár
TG Therapeutics Investigational Trial Site
RECRUITING
Kistarsca
TG Therapeutics Investigational Trial Site
RECRUITING
Pécs
Ukraine
TG Therapeutics Investigational Trial Site
RECRUITING
Cherkasy
TG Therapeutics Investigational Trial Site
RECRUITING
Ivano-frankivsk
TG Therapeutics Investigational Trial Site
RECRUITING
Ivano-frankivsk
TG Therapeutics Investigational Trial Site
RECRUITING
Ivano-frankivsk
TG Therapeutics Investigational Trial Site
RECRUITING
Kyiv
TG Therapeutics Investigational Trial Site
RECRUITING
Kyiv
TG Therapeutics Investigational Trial Site
RECRUITING
Lviv
TG Therapeutics Investigational Trial Site
RECRUITING
Lviv
TG Therapeutics Investigational Trial Site
RECRUITING
Ternopil
TG Therapeutics Investigational Trial Site
RECRUITING
Vinnytsia
TG Therapeutics Investigational Trial Site
RECRUITING
Vinnytsia
Contact Information
Primary
TG Therapeutics Clinical Support Team
clinicalsupport@tgtxinc.com
1-877-575-8489
Time Frame
Start Date: 2025-07-09
Estimated Completion Date: 2028-12-31
Participants
Target number of participants: 360
Treatments
Active_comparator: Ublituximab IV
Approved dosage.
Experimental: Ublituximab SC Regimen 1
New regimen.
Experimental: Ublituximab SC Regimen 2
New regimen.
Related Therapeutic Areas
Sponsors
Leads: TG Therapeutics, Inc.