Phase 3 Study of Modified Ublituximab Treatment for Relapsing Multiple Sclerosis Evaluating Safety, Effectiveness, and Drug Levels

What this Trial Is About

Researchers are evaluating the safety, effectiveness, and pharmacokinetics of a modified dosing schedule of ublituximab for adults with relapsing multiple sclerosis RMS. This phase 3b study has three parts Part A is an open-label single-arm study, Part B is a randomized, double-blind, placebo-controlled study, and Part C is an open-label single-arm study focusing on participants who had a suboptimal response to prior anti-CD20 therapy. The primary goal is to measure changes in T1 Gadolinium-enhancing brain lesions and drug levels in the blood. Participants receive ublituximab by intravenous infusion following different dosing regimens depending on the study part. In Part A, participants initially received infusions on Day 1 of Week 1, Day 15 if applicable, and Week 24. In Part B, participants receive either 600 mg ublituximab on Week 1 Day 1 followed by placebo on Day 15 and 450 mg ublituximab at Week 24, or 150 mg ublituximab on Day 1 followed by 450 mg on Day 15 and Week 24. Part C participants receive 150 mg on Day 1, then 450 mg on Day 15 and Week 24. Enrollment in Parts A and B has closed according to protocol updates. During the study, participants undergo regular assessments including brain imaging to track T1 Gadolinium-enhancing lesions, blood tests to measure drug levels, and evaluations for infusion-related reactions. Treatment satisfaction questionnaires are collected at baseline, Week 24, and Week 48. Safety and efficacy are monitored up to 48 weeks. The total study duration covers treatment and follow-up visits, with primary outcomes measured at Week 48 to assess changes from baseline.

Study to Evaluate Safety, Efficacy and Pharmacokinetics (PK) of a Modified Regimen of Ublituximab