The primary purpose of this phase 3b study is to assess the efficacy of a modified regimen of ublituximab in participants with relapsing multiple sclerosis (RMS) as measured by T1 Gadolinium (Gd)-enhancing lesions in Part A; PK in Part B along with efficacy of ublituximab as measured by T1 Gd-enhancing lesions in participants who had a suboptimal experience on prior anti-CD20 therapy in Part C. The study consists of 3 parts: Part A is single-armed and open-label, Part B is randomized, double-blind, placebo-controlled, and Part C is single-armed and open-label.
Diagnosis of RMS (2017 Revised McDonald criteria).
Participants naïve to treatment.
Participants previously treated with a disease modifying therapy (DMT) who have discontinued treatment prior to consent and meet the washout requirements.
Expanded Disability Status Scale (EDSS) score ≤ 5.5 at screening.
History of any serious 3 Infusion Related Reaction (IRR) on prior anti-CD20 therapy.
Primary-progressive multiple sclerosis (PPMS) or inactive Secondary Progressive MS (SPMS).
Active chronic (or stable but treated with immune therapy) disease of the immune system other than MS (e.g., rheumatoid arthritis, scleroderma, Sjögren's syndrome, Crohn's disease, ulcerative colitis, etc.) or immunodeficiency syndrome (hereditary immune deficiency, drug-induced immune deficiency, etc.).
Current evidence or known history of clinically significant infection, including: chronic, recurrent, or ongoing active viral, bacterial, or fungal infectious disease requiring long term systemic treatment such as, but not limited to chronic urinary tract infection, chronic pulmonary infection with bronchiectasis, tuberculosis, or active hepatitis C virus (HCV).
Parallel
Ublituximab
Biological/VaccineAdministered as an intravenous (IV) infusion.
Placebo
DrugIV infusion
Part A and Part C: Percentage of Participants With no Change or Reduction in Number of T1 Gd-Enhancing Lesions From Baseline to Week 48
The Gd-enhancing T1 lesions will be evaluated using magnetic resonance imaging (MRI) technique.
Part B: Area Under the Curve Over the First 16 Weeks (AUC0-W16) of Ublituximab
Parts A: Percentage of Participants Free of T1 Gd-Enhancing Lesions
The Gd-enhancing T1 lesions will be evaluated using MRI technique.
Parts A and B: Percentage of Participants Experiencing Infusion Related Reactions (IRRs)
IRRs are defined as infusion related adverse events (AEs) that occur within one day of an infusion and resolve within 7 days. IRRs will be reported by investigator.
Parts A: Change From Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM-9) Scores
The TSQM-9 is a 9-item questionnaire with 3 domains: Satisfaction, convenience, and effectiveness.
Click on the lead sponsor to view all of their trials.
