Effects of Ublituximab on Motor Functions in Multiple Sclerosis

Recruiting now · Early Phase 1

Conditions studied: Multiple Sclerosis (MS) - Relapsing-remitting

In brief

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.

Key facts

Study ID: NCT06629428
Run by: Georgia State University
People needed: 25
Starts: 2025-11-13
Expected to finish: 2026-12-31
Last updated by the study team: 2026-02-09

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Ability to provide written, informed consent and to be compliant with the schedule of protocol assessments.
Ages between 18 and 55 years old at screening.
Clinically confirmed active, relapsing forms of MS based on the revised McDonald criteria.
Can walk at least 25 feet independently with or without assistive devices at screening.
Can stand independently for at least 30 seconds.
Not pregnant at screening and throughout the study.
A negative urine or serum pregnancy test must be available for premenopausal women and for women \&lt; 12 months after the onset of menopause at screening, unless they have undergone surgical sterilization.
Women of childbearing potential must agree to remain abstinent (refrain from heterosexual intercourse) or use one method of contraception with a failure rate of \&lt; 1% per year or a barrier method supplemented with spermicide. Contraception must continue for the duration of study treatment and for at least 6 months after the last dose of study treatment.
A woman is considered to be of childbearing potential if she is postmenarcheal, has not reached a postmenopausal state (≥ 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of the ovaries and/or uterus).
Examples of contraceptive methods with a failure rate of \&lt; 1% per year include bilateral tube ligation, male sterilization, established hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices.
The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence and withdrawal are not acceptable methods of contraception.
Examples of barrier methods supplemented with the use of spermicide include male or female condom, vaginal ring, cap, diaphragm, or sponge.
No other neurological conditions and recent musculoskeletal injuries.
Can read and understand English.
No significant cognitive impairment.

You may not qualify if…

Basic Exclusion Criteria
History of MS types other than relapsing MS at screening (such as primary-progressive MS, inactive SPMS).
History of life-threatening infusion reaction on ublituximab, any of its ingredients, or prior anti-clusters of differentiation 20 (CD20) therapy.
Hypersensitive to any of the ingredients of ublituximab.
Do not understand English.
Exclusions Related to General Health
Pregnancy or lactation.
Have any other known neurological diseases which may mimic MS, including but not limited to: Neuromyelitis optica, Lyme disease, untreated vitamin B12 deficiency, neurosarcoidosis, and cerebrovascular disorders.
History of clinically significant central nervous system (CNS) trauma (e.g., traumatic brain injury, cerebral contusion, spinal cord compression, etc.).
History of liver disease.
Active hepatitis B virus (HBV) confirmed by positive results for Hepatitis B surface antigen (HBsAg) and anti-HBV tests.
Current evidence or known history of clinically significant infection.
Suffering from coexisting psychiatric disorders, neurological disorders, or severe medical illness.
Current severe depression and/or suicidal ideation.
Significant cognitive impairment (Montreal Cognitive Assessment or Montreal Cognitive Assessment (MoCA) score \&lt; 24).
New onset, unstable orthopedic comorbid diagnoses (within 3 months and uncontrolled).
History or currently active primary or secondary immunodeficiency.
Receipt of a live vaccine within 6 weeks before baseline.
Skin is allergic to transparent double-side tapes.
Any concomitant disease that may require chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study.
History or currently active primary or secondary immunodeficiency.
Lack of peripheral venous access.
History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies.
Significant or uncontrolled somatic disease or any other significant disease that may preclude a patient from participating in the study.
Congestive heart failure (NYHA III or IV functional severity).

Where it is running

Atlanta Neuroscience Institute — Atlanta, Georgia, United States (enrolling)
Georgia State University — Atlanta, Georgia, United States

Full record on ClinicalTrials.gov

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