Can a new MS drug help you walk better and avoid falls?
NCT ID NCT06629428
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase study tests whether ublituximab, a drug for relapsing multiple sclerosis, can improve walking function and reduce fall risk. Twenty-five participants will receive the drug for 48 weeks, with walking, disability, and thinking tests before, during, and after treatment. They will also be exposed to a simulated slip on a treadmill to see how well they recover.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- ublituximab
- What this could lead to
- If it works, this could show that ublituximab improves walking and reduces falls in people with relapsing MS.
- What could go wrong
- This is a very small, early-phase study with only 25 participants, so results may not apply to everyone. It is designed to measure walking changes, not to prove long-term disease control.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
-
About 25 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Nov 2025
- Expected to finish
-
Dec 2026
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 55 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Ability to provide written, informed consent and to be compliant with the schedule of protocol assessments. 2. Ages between 18 and 55 years old at screening. 3. Clinically confirmed active, relapsing forms of MS based on the revised McDonald criteria. 4. Can walk at least 25 feet independently with or without assistive devices at screening. 5. Can stand independently for at least 30 seconds. 6. 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. 7. No other neurological conditions and recent musculoskeletal injuries. 8. Can read and understand English. 9. No significant cognitive impairment. Exclusion Criteria: Basic Exclusion Criteria 1. History of MS types other than relapsing MS at screening (such as primary-progressive MS, inactive SPMS). 2. History of life-threatening infusion reaction on ublituximab, any of its ingredients, or prior anti-clusters of differentiation 20 (CD20) therapy. 3. Hypersensitive to any of the ingredients of ublituximab. 4. Do not understand English. Exclusions Related to General Health 5. Pregnancy or lactation. 6. 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. 7. History of clinically significant central nervous system (CNS) trauma (e.g., traumatic brain injury, cerebral contusion, spinal cord compression, etc.). 8. History of liver disease. 9. Active hepatitis B virus (HBV) confirmed by positive results for Hepatitis B surface antigen (HBsAg) and anti-HBV tests. 10. Current evidence or known history of clinically significant infection. 11. Suffering from coexisting psychiatric disorders, neurological disorders, or severe medical illness. 12. Current severe depression and/or suicidal ideation. 13. Significant cognitive impairment (Montreal Cognitive Assessment or Montreal Cognitive Assessment (MoCA) score \< 24). 14. New onset, unstable orthopedic comorbid diagnoses (within 3 months and uncontrolled). 15. History or currently active primary or secondary immunodeficiency. 16. Receipt of a live vaccine within 6 weeks before baseline. 17. Skin is allergic to transparent double-side tapes. 18. Any concomitant disease that may require chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study. 19. History or currently active primary or secondary immunodeficiency. 20. Lack of peripheral venous access. 21. History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies. 22. Significant or uncontrolled somatic disease or any other significant disease that may preclude a patient from participating in the study. 23. Congestive heart failure (NYHA III or IV functional severity). 24. Known active bacterial, viral, fungal, mycobacterial infection or other infection, excluding fungal infection of nail beds. 25. Infection requiring hospitalization or treatment with i.v. antibiotics within four weeks prior to baseline visit or oral antibiotics within two weeks prior to baseline visit. 26. History or known presence of recurrent or chronic infection (e.g., hepatitis B or C, HIV, syphilis, tuberculosis). 27. History of progressive multifocal leukoencephalopathy (PML). 28. History of malignancy, including solid tumors and hematological malignancies, except basal cell carcinoma, in situ squamous cell carcinoma of the skin, and in situ carcinoma of the cervix of the uterus that has been previously completely excised with documented clear margins. 29. History of alcohol or drug abuse within 24 weeks prior to baseline. 30. History or laboratory evidence of coagulation disorders. Exclusions Related to Medications 31. Receipt of any live of live-attenuated vaccines within 4 weeks prior to first drug product administration. 32. Treatment with any investigational agent within 24 weeks of screening (Visit 1) or five half-lives of the investigational drug (whichever is longer). 33. Systemic corticosteroid therapy within 4 weeks prior to screening. 34. Any previous treatment with alemtuzumab (Campath), anti-cluster of differentiation 4 (CD4), cladribine, mitoxantrone, daclizumab, tecfidera (BG12), teriflunomide, laquinimod, total body irradiation or bone marrow transplantation. 35. Treatment with cyclophosphamide, azathioprine, mycophenolate mofetil (MMF), cyclosporine, methotrexate, or natalizumab within 24 months prior to screening. 36. Treatment with intravenous immunoglobulin within 12 weeks prior to baseline. 37. Treatment with anti-CD20 or other B cell-directed treatment. Exclusions Related to Motor Function 38. Cannot walk at least 25 feet and stand for at least 30 seconds independently. 39. Weak or blind vision may impair their ability to walk. Exclusions Related to Musculoskeletal, Cardiovascular, and Orthopedic Conditions 40. Broken bones as an adult in the past year. 41. Have received neurological treatment, such as Botox, in the past six months. 42. Heart attack, angioplasty, or coronary artery bypass graft in the past six months. 43. Congestive heart failure (NYHA III or IV functional severity). 44. Surgery on back, hip, shoulder, or total joint replacement of hip or knee joint less than two years ago. 45. Respiratory conditions (lung cancer, bronchitis, emphysema, asthma, shortness of breath) not under regular medical care or the patient is medically unstable.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Multiple sclerosis (MS) - relapsing-remitting are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
2 sites. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Atlanta Neuroscience Institute
RECRUITINGAtlanta, Georgia, 30327, United States
-
Georgia State University
NOT_YET_RECRUITINGAtlanta, Georgia, 30303, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Gut health meets diet: a new angle on managing multiple sclerosis
- Brain scans to reveal if new MS drug quietly calms inflammation
- Could a lighter MS treatment keep the disease at bay?
- A motorized hip brace may help MS patients walk better — small study puts it to the test
- Ear stimulation may help repair nerve damage in multiple sclerosis
- Could a gentle zapping of the brain ease MS fatigue and brain fog?