NCT06629428

Effects of Ublituximab on Motor Functions in Multiple Sclerosis

Effects of Ublituximab on Unperturbed and Perturbed Ambulatory Functions in People With Relapsing Multiple Sclerosis

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: Georgia State University · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to test if ublituximab changes walking functions and fall risk in people with relapsing multiple sclerosis (RMS). Twenty-five qualified people with RMS will undergo a 48-week ublituximab treatment. Before, 24 weeks into, and after the treatment, their ambulatory function, disability status, and cognition will be assessed. Additionally, they will experience large-scale slip perturbations on a treadmill under the protection of a safety harness at the last assessment. The outcome measures will be compared across the assessments to examine the effects of ublituximab on improving their walking function, disability status, cognition, and the responses to the unexpected slip perturbation.

Detailed description

The primary objective of this single-arm and pretest-posttest study will be to examine the effects of treatment with ublituximab on ambulatory functions during unperturbed walking and large-scale gait slips (dynamic gait stability and slip-fall) among people with relapsing MS over a 12-month treatment period. Additionally, the effects of ublituximab on disease progression and cognitive functions will be evaluated. Twenty-five qualified people with relapsing multiple sclerosis (RMS) will be enrolled to this study. Before the treatment, their ambulatory functions during regular walking will be assessed in terms of their spatiotemporal gait parameters. This assessment is considered the baseline test. Their disease progression will be evaluated by the neurological exam and serum neurofilament light chain. Their cognitive function will be tested by the Montreal Cognitive Assessment. Then, they will undergo the 48-week ublituximab treatment. At the mid-point of the treatment period, they will attend another assessment session, which is identical to the baseline session. Immediately after the 48-week treatment, the same assessments will be executed again as the baseline test. In addition, all participants will experience repeated unexpected slip perturbations while walking on a treadmill under the protection of a full-body safety harness. Their response to the the slips will be quantified by their dynamic balance, reaction times of the lower leg muscles, and adaptation rate to the repeated slips. All the measurements will be analyzed to identify the effects of ublituximab on ambulatory functions, disease progression, and cognitive status of people with relapsing multiple sclerosis. Our findings will potentially lead to earlier adoption of this highly efficacious disease-modifying treatment and thus likely improve long-term patient care outcomes. This study will uncover how ublituximab impacts ambulatory function and mobility among people with relapsing MS. This will augment our current understanding of ublituximab which focuses on the aspect of the disease progression. Given mobility is critical for people with MS to maintain their employment, independence, participation in social events, and thus the quality of life, this study will have great potential to scientifically enhance our scientific understanding of effects of ublituximab and to clinically improve patient care.

Conditions

• Multiple Sclerosis (MS) - Relapsing-remitting

Interventions

Type	Name	Description
DRUG	Ublituximab	The participants will receive 48 weeks of treatment with ublituximab.

Timeline

• Start date: 2025-11-13
• Primary completion: 2026-06-30
• Completion: 2026-12-31
• First posted: 2024-10-08
• Last updated: 2026-02-09

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study