RecruitingEarly Phase 1

Effects of Ublituximab on Motor Functions in Multiple Sclerosis

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 55 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether ublituximab changes walking and the risk of falls in adults with relapsing multiple sclerosis (MS), a form of MS with flare-ups. Treatment lasts 48 weeks and includes tests of walking, disability, memory, and thinking. At the final visit, participants will face sudden slips on a treadmill while wearing a safety harness.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be 18 to 55 years old.
  • Have active, relapsing MS confirmed by a doctor.
  • Be able to walk at least 25 feet on your own, with or without a walking aid.
  • Be able to stand on your own for at least 30 seconds.
  • Give written consent and follow the study visit and testing schedule.
  • Read and understand English, with no major problems with memory or thinking.
  • Have no other nerve or brain conditions and no recent muscle, bone, or joint injuries.
  • Not be pregnant during the study. Pregnancy testing may be required. Women who could become pregnant must avoid sex with men or use required birth control during treatment and for 6 months after the last dose.

Who can't join

  • Have a type of MS other than relapsing MS, another brain or nerve disease, a major brain or spinal cord injury, or major memory or thinking problems.
  • Be pregnant or breastfeeding, or have severe depression, thoughts of suicide, or other mental health disorders.
  • Have liver disease, a weak immune system, serious or repeated infections, blood-clotting problems, or a history of cancer, except certain fully removed skin or cervical cancers.
  • Have had a life-threatening reaction to ublituximab or similar treatment, severe reactions to certain antibody medicines, an allergy to study drug ingredients or clear double-sided tape, or no usable vein for treatment.
  • Have used certain MS drugs, immune-system treatments, steroids, research drugs, or live vaccines within the study's restricted time periods. Some past treatments are not allowed at any time.
  • Have vision problems that affect walking, a recent uncontrolled bone or joint condition, an adult bone fracture in the past year, certain surgeries in the past 2 years, or nerve treatments such as Botox in the past 6 months.
  • Have severe heart failure, a heart attack or heart procedure in the past 6 months, unstable lung disease or lung disease without regular care, or another serious or uncontrolled illness.
  • Have a history of alcohol or drug abuse in the 24 weeks before the starting visit.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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.

Study sites (2)

GA