Effects of Ublituximab on Motor Functions in Multiple Sclerosis

NCT06629428 | Recruiting Early Phase 1 FDA Drug

• 1 other identifier: H25013
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Multiple Sclerosis (MS) - Relapsing-remitting

Keywords

ublituximab; gait function; disease progression; perturbed walking; Cognition

Outcome Measures

Primary Outcomes (2)

• slip-fall

  The outcome of a slip trial will be deemed a fall if the peak load cell force exceeds 30% of the body weight.

  48 weeks

• Dynamic gait stability during slip

  For a slip, dynamic gait stability will be calculated at two events: the slipping foot touchdown and the recovery foot liftoff.

  48 weeks

Secondary Outcomes (10)

• Dynamic gait stability during walking

  weeks 0, 24, and 48

• Spatiotemporal gait parameters during walking

  Weeks 0, 24, and 48

• Leg muscle strength

  Weeks 0, 24, and 48

• Leg Muscle Activities

  Weeks 0, 24, and 48

• Sway index

  Weeks 0, 24, and 48

Study Arms (1)

Ublituximab

EXPERIMENTAL

This arm will receive a 48-week ublituximab treatment.

Drug: Ublituximab

Interventions

Ublituximab DRUG

The participants will receive 48 weeks of treatment with ublituximab.

Ublituximab

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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 \< 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 \< 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 \< 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:

• 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.
• 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 \< 24).
• New onset, unstable orthopedic comorbid diagnoses (within 3 months and uncontrolled).
• History or currently active primary or secondary immunodeficiency.

Sponsors & Collaborators

• Georgia State University: lead
• Atlanta Neuroscience Institute: collaborator

Study Sites (2)

Georgia State University

Atlanta, Georgia, 30303, United States

NOT YET RECRUITING

Atlanta Neuroscience Institute

Atlanta, Georgia, 30327, United States

RECRUITING

Related Publications (5)

• Kuhle J, Plavina T, Barro C, Disanto G, Sangurdekar D, Singh CM, de Moor C, Engle B, Kieseier BC, Fisher E, Kappos L, Rudick RA, Goyal J. Neurofilament light levels are associated with long-term outcomes in multiple sclerosis. Mult Scler. 2020 Nov;26(13):1691-1699. doi: 10.1177/1352458519885613. Epub 2019 Nov 4.

  PMID: 31680621 BACKGROUND

• Yang F, Bhatt T, Pai YC. Generalization of treadmill-slip training to prevent a fall following a sudden (novel) slip in over-ground walking. J Biomech. 2013 Jan 4;46(1):63-9. doi: 10.1016/j.jbiomech.2012.10.002. Epub 2012 Nov 8.

  PMID: 23141636 BACKGROUND

• Yang F, Pai YC. Automatic recognition of falls in gait-slip training: Harness load cell based criteria. J Biomech. 2011 Aug 11;44(12):2243-9. doi: 10.1016/j.jbiomech.2011.05.039. Epub 2011 Jun 21.

  PMID: 21696744 BACKGROUND

• Carpenter MR, Carpenter RL, Peel J, Zukley LM, Angelopoulou KM, Fischer I, Angelopoulos TJ, Rippe JM. The reliability of isokinetic and isometric leg strength measures among individuals with symptoms of mild osteoarthritis. J Sports Med Phys Fitness. 2006 Dec;46(4):585-9.

  PMID: 17119524 BACKGROUND

• Simoneau GG. Kinesiology of walking. In: Neumann D. A., editor. Kinesiology of the Musculoskeletal System: Foundations of Physical Rehabilitation. St. Louis: Mosby; 2010. p. 636.

  BACKGROUND

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting; Disease Progression

Interventions

ublituximab

Condition Hierarchy (Ancestors)

Multiple Sclerosis; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Mittie Mitchell, RN, CRC

CONTACT

404-351-0205; mmitchell@atlneuroinstitute.org

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2024
• First Posted: October 8, 2024
• Study Start: November 13, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 9, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)