Status:
RECRUITING
A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, Radiological and Clinical Effects of Subcutaneous Ublituximab in Participants With Relapsing Multiple Sclerosis (RMS)
Lead Sponsor:
TG Therapeutics, Inc.
Conditions:
Relapsing Multiple Sclerosis
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief 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.
Detailed Description
This is a Phase 3, open label, parallel-group, multicenter study in participants with RMS.
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Primary-progressive Multiple Sclerosis (PPMS) or inactive Secondary Progressive Multiple Sclerosis (SPMS).
- Active chronic disease of the immune system other than MS or immunodeficiency syndrome.
- Participants with significantly impaired bone marrow function or significant leukopenia or thrombocytopenia.
- 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.
Key Trial Info
Start Date :
July 9 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2028
Estimated Enrollment :
360 Patients enrolled
Trial Details
Trial ID
NCT07211633
Start Date
July 9 2025
End Date
December 31 2028
Last Update
November 28 2025
Active Locations (42)
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1
TG Therapeutics Investigational Trial Site
Banja Luka, Bosnia and Herzegovina, 78000
2
TG Therapeutics Investigational Trial Site
Bihać, Bosnia and Herzegovina, 77000
3
TG Therapeutics Investigational Trial Site
Mostar, Bosnia and Herzegovina, 71000
4
TG Therapeutics Investigational Trial Site
Saravejo, Bosnia and Herzegovina, 71000