RecruitingPhase 3NCT07211633
A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, Radiological and Clinical Effects of Subcutaneous Ublituximab in Participants With Relapsing Multiple Sclerosis (RMS)
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
Sponsor
TG Therapeutics, Inc.
Enrollment
360 participants
Start Date
Jul 9, 2025
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 18 YearsMax Age: 65 Years
Inclusion Criteria4
- 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 a highly effective method of contraception from consent and for 6 months after the last dose of ublituximab.
Exclusion Criteria4
- 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.
Interventions
BIOLOGICALUblituximab
Administered as an IV infusion.
BIOLOGICALUblituximab
Administered as an SC injection.
Locations(42)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07211633
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