Early Phase 1 Multiple Sclerosis Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who are able to give written consent and can follow the study schedule.
• People aged between 18 and 55 years old at the time of screening.
• People with a confirmed diagnosis of active, relapsing multiple sclerosis (MS), based on recognised diagnostic criteria.
• People who can walk at least 25 feet (about 7.5 metres) on their own, with or without a walking aid.
• People who can stand on their own for at least 30 seconds.
• People who are not pregnant at the time of screening or during the study. Women who could become pregnant must have a negative pregnancy test at screening, and must agree to use a reliable method of contraception (with less than 1% failure rate per year, or a barrier method with spermicide) for the full duration of the study and for at least 6 months after the last dose. Acceptable contraceptive methods include hormonal contraceptives that stop ovulation, hormonal or copper intrauterine devices (IUDs), tubal ligation, or male sterilisation. Barrier methods such as condoms, diaphragms, caps, vaginal rings, or sponges used together with spermicide are also acceptable. Periodic abstinence and withdrawal are not accepted as contraceptive methods.
• People who do not have other neurological conditions or recent musculoskeletal injuries.
• People who can read and understand English.
• People who do not have significant problems with memory or thinking.

Who may not be able to join:

• People who have a form of MS other than relapsing MS, such as primary-progressive MS or inactive secondary-progressive MS.
• People who have had a serious or life-threatening reaction to ublituximab, any of its ingredients, or to a previous anti-CD20 therapy (a type of medication that targets certain immune cells).
• People who are allergic to any ingredient in ublituximab.
• People who cannot read or understand English.
• People who are pregnant or breastfeeding.
• People who have another neurological condition that can look like MS, such as neuromyelitis optica, Lyme disease, untreated vitamin B12 deficiency, neurosarcoidosis, or blood vessel disorders in the brain.
• People with a history of significant brain or spinal cord injury, such as traumatic brain injury or spinal cord compression.
• People with a history of liver disease.
• People with active hepatitis B infection, confirmed by specific blood tests.
• People with a current or known significant infection.
• People with coexisting psychiatric disorders, other neurological disorders, or serious medical illness.
• People currently experiencing severe depression or suicidal thoughts.
• People with significant memory or thinking difficulties (as measured by a standard cognitive assessment score below 24).
• People with a new or unstable bone or joint condition that has started within the past 3 months and is not under control.
• People with a current or past immune system deficiency condition.
• People who have received a live vaccine within 6 weeks before the study start.
• People whose skin is allergic to transparent double-sided tape.
• People who need ongoing treatment with corticosteroids or immune-suppressing medications during the study.
• People without suitable vein access for intravenous treatment.
• People with a history of severe allergic or anaphylactic reactions to certain types of antibody-based medications (humanised or murine monoclonal antibodies).
• People with a significant or uncontrolled medical condition that may prevent safe participation.
• People with moderate to severe heart failure (confirmed with trial site for exact classification).
• People with a known active bacterial, viral, fungal, or other infection (except fungal nail infections).
• People who have been hospitalised for an infection or treated with intravenous antibiotics in the 4 weeks before the study start, or with oral antibiotics in the 2 weeks before the study start.
• People with a history of recurring or chronic infections such as hepatitis B or C, HIV, syphilis, or tuberculosis.
• People with a history of a serious brain condition called progressive multifocal leukoencephalopathy (PML).
• People with a history of cancer, except for certain completely removed skin cancers or cervical carcinoma in situ with clear margins.
• People with a history of alcohol or drug misuse in the 24 weeks before the study start.
• People with a history of or test results showing blood clotting disorders.
• People who have received a live or live-attenuated vaccine within 4 weeks before the first dose of the study drug.
• People who have taken part in another clinical trial within 24 weeks of screening, or within five half-lives of the experimental drug used in that trial, whichever is longer.
• People who have used systemic corticosteroid therapy within 4 weeks before screening.
• People who have previously been treated with certain specific MS or immune-suppressing medications, including alemtuzumab, cladribine, mitoxantrone, daclizumab, dimethyl fumarate (tecfidera), teriflunomide, laquinimod, total body irradiation, or bone marrow transplantation.
• People who have been treated with certain immune-suppressing medications (including cyclophosphamide, azathioprine, mycophenolate mofetil, cyclosporine, methotrexate, or natalizumab) within the past 24 months.
• People who have received intravenous immunoglobulin within 12 weeks before the study start.
• People who have previously been treated with anti-CD20 therapy or other B-cell-targeted treatments.
• People who cannot walk at least 25 feet or stand independently for at least 30 seconds.
• People whose vision is severely impaired in a way that affects their ability to walk safely.
• People who have broken a bone as an adult in the past year.
• People who have received neurological treatments such as Botox injections in the past six months.
• People who have had a heart attack, angioplasty, or coronary artery bypass surgery in the past six months.
• People with respiratory conditions (such as lung cancer, bronchitis, emphysema, or asthma) that are not under regular medical care or are medically unstable.
• People who have had back, hip, or shoulder surgery, or a total hip or knee joint replacement, within the past two years.

Important: Always verify eligibility with the trial site directly before applying.