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Last Updated: 10/31/2025
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
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.
A Post-marketing Study Evaluating the Presence and Concentration of BRIUMVI™ in Breast Milk (PROVIDE)
Summary: The primary objective of the lactation study is to characterize the presence and concentration of BRIUMVI™ in breast milk among breastfeeding participants who receive BRIUMVI™ therapeutically for the treatment of relapsing forms of multiple sclerosis (RMS).
REal World ExperieNce With BRIUMVI® (UblituximAB-xiiy) Treated Patients: A Longitudinal REgistry Study (ENABLE)
Summary: The purpose of this study is to evaluate safety, effiectiveness, and to gain insight into the treatment experience of participants prescribed BRIUMVI® (ublituximab-xiiy) in the real-world setting
Evaluating Safety, Efficacy and Pharmacokinetics of a Modified Regimen of Ublituximab (ENHANCE )
Summary: The primary purpose of this phase 3b study is to assess the efficacy of a modified regimen of ublituximab as measured by T1 Gadolinium (Gd)-enhancing lesions and pharmacokinetics in participants with Relapsing Multiple Sclerosis (RMS). The study consists of 2 parts: Part A is single-armed and open-label and Part B is randomized, double-blind, placebo-controlled.
BRIUMVI® Pregnancy Registry: A Prospective Study of Pregnancy and Infant Outcomes in Patients Treated With BRIUMVI®
Summary: The primary objective of the study is to compare the prevalence rate of major congenital malformations (MCM) between 2 cohorts of pregnant participants with MS who are exposed to BRIUMVI® and who are unexposed to BRIUMVI®.
A Multicenter Randomized Controlled Trial of Best Available Therapy Versus Autologous Hematopoietic Stem Cell Transplant for Treatment-Resistant Relapsing Multiple Sclerosis (ITN077AI)
Summary: This is a multi-center prospective rater-masked (blinded) randomized controlled trial of 156 participants, comparing the treatment strategy of Autologous Hematopoietic Stem Cell Transplantation (AHSCT) to the treatment strategy of Best Available Therapy (BAT) for treatment-resistant relapsing multiple sclerosis (MS). Participants will be randomized at a 1 to 1 (1:1) ratio. All participants will be...
Understanding the 'Durable Effect' Concept of B-cell Modulating Therapies
Summary: This prospective, observational clinical study aims to longitudinally assess peripheral immune cell profiles of patients with relapsing-remitting multiple sclerosis (RRMS) receiving anti-CD20 therapy with ofatumumab (OFA), ocrelizumab (OCR), ublituximab (UBX), and rituximab (RTX). Throughout the study, clinical data - including relapse events, patient scores, and neuropsychological parameters - wi...
Pregnancy Registry, Infants, Serum/Milk Analysis (PRISMA): Pregnancy Registry for Women With Chronic Conditions
Summary: PRISMA, is a pregnancy registry study, focused on comprehensively collecting information about pregnancy in women with chronic neurological conditions from across the United States and internationally. Depending on their specific condition (MS, CIS, NMOSD, or other) and their specific treatment, participants will be asked to contribute to different aspects of the study. (1) The biosamples will be ...
A Single-Center, Prospective Cohort Study to Characterize the Safety and Efficacy of Ublituximab in Older Adults With Relapsing Forms of Multiple Sclerosis (RMS)
Summary: The purpose of this study is to evaluate the safety of ublituximab use in the older MS adult population, as measured by incidence of infection rate
Last Updated: 10/31/2025