NCT04035005

Who might be able to join this trial:

• Your MS disability level (measured by a standard scale called EDSS) must be between 3.0 and 8.0 at the start of the trial
• How long you have had MS symptoms matters and depends on your disability level: less than 10 years if your EDSS score is 5.0 or below; less than 15 years if your score is between 5.5 and 6.5; or less than 20 years if your score is between 7.0 and 8.0
• You must have a past or current spinal fluid test result showing certain markers of MS-related immune activity (elevated IgG index or oligoclonal bands) (confirm with trial site)
• You must be able to complete a standard hand-function test (picking up pegs) in more than 25 seconds on average across both hands, but within 240 seconds per hand
• Your neurological condition must have been stable for at least 30 days before the trial starts
• If you have previously taken medicines that affect the immune system for MS, you must have stopped them long enough ago, as specified for each drug
• Women who could become pregnant must agree to use reliable contraception or remain abstinent during treatment and for 6 or 12 months after the last dose
• Women who cannot become pregnant (due to surgery or menopause, and not currently on hormone therapy for menopause) may also be eligible

Who may not be able to join:

• People who have been diagnosed with relapsing-remitting or secondary progressive MS
• People who currently have a serious active infection, including bacterial, viral, fungal, or tuberculosis infections
• People who have had, or are suspected to have had, a serious brain infection called PML (progressive multifocal leukoencephalopathy)
• People with a known active cancer, or who are being monitored for cancer returning
• People with a weakened immune system
• People who received a live vaccine within 6 weeks before joining the trial
• People who cannot have an MRI scan, or who cannot receive the contrast dye used during MRI
• People who need MS symptom treatments or physiotherapy but are not yet on a stable routine, or who have started such treatments within 4 weeks of the trial start
• People who cannot take the pre-medications given before the trial drug infusion due to uncontrolled psychosis (affects steroid use) or closed-angle glaucoma (affects antihistamine use)
• People with other known neurological conditions
• Women who are pregnant, breastfeeding, or planning to become pregnant during the study or within 6 to 12 months after the last dose
• People without suitable vein access for an intravenous infusion
• People with significant uncontrolled conditions affecting the heart, lungs, kidneys, liver, hormonal system, or digestive system
• People with any condition requiring long-term steroid or immune-suppressing medicines
• People with a history of alcohol or drug misuse
• People with a history of immune deficiency conditions
• People who have taken part in another clinical trial or used an experimental treatment within approximately 24 weeks before screening, or within 5 half-lives of that drug (whichever is longer)
• People who have previously been treated with therapies that target B-cells (a type of immune cell)
• People who have had a bone marrow or stem cell transplant
• People who have had any organ transplant or taken anti-rejection medicines
• People who have received intravenous immunoglobulin (IV Ig) or plasma exchange treatment within 12 weeks before joining
• People who have taken systemic steroid medicines within 4 weeks before screening
• Women with a positive pregnancy test at screening or at the start of the trial
• People who test positive for hepatitis B
• People who do not show signs of MS activity on their MRI scan, if a certain number of participants without MRI activity have already been enrolled (confirm with trial site)

For the later open-label extension phase of the trial (confirm with trial site):

• You must have completed or still be taking part in the first 144-week phase of the trial, and your doctor must feel you could benefit from continuing the treatment
• The same pregnancy and contraception requirements listed above apply

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