Phase 3 Multiple Sclerosis Trial, Recruiting

Written by an AI model from the 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 have given written consent to take part in the trial
• People who have been diagnosed with relapse-onset secondary progressive multiple sclerosis (a form of MS that began with relapses and has since entered a progressive stage), based on specific diagnostic guidelines from 2017
• People whose disability has worsened over the past 24 months, as measured by a standard MS disability scale (EDSS)
• People who have had no MS relapses in the last 12 months
• People whose disability level falls within a specific range on the EDSS scale (a score between 3.5 and 7.5)
• People aged between 30 and 65 years
• People who have had MS for 10 years or longer
• Women who have not yet reached menopause and who agree to either avoid heterosexual intercourse or use a highly effective form of contraception (one with less than 1% failure rate) from the time of enrolment until 6 months after the last dose of the trial medication
• Men who agree to either avoid heterosexual intercourse or use a barrier form of contraception, with their female partners also using a highly effective contraception method, from enrolment until 6 months after the last dose of the trial medication
• People who are able to meet all of the trial's requirements, as determined by the trial doctor

Who may not be able to join:

• People who have not provided written consent
• People who have previously been treated with a medicine called cladribine
• People who have a known allergy or sensitivity to the trial medication
• People for whom a doctor determines that treatment with interferon beta, siponimod, or mitoxantrone is a suitable and acceptable option
• People who are unable to have an MRI scan
• People who are pregnant or breastfeeding
• People who are not willing to use the contraception methods required by the trial
• People who have other conditions affecting the nervous system, such as brain tumours, stroke, traumatic brain injury, brain or spinal cord inflammation, vitamin B12 deficiency, or other diseases that affect the myelin (the protective coating of nerves) apart from MS
• People who have serious other health conditions, such as cancer, liver failure, kidney failure, heart failure, or any other condition that could put them at risk or make it impossible to complete the trial requirements
• People who have had an MS relapse in the last 12 months
• People who have been on long-term treatment with steroid medicines or immune-suppressing drugs (such as azathioprine, methotrexate, or cyclosporine) in the last 6 months
• People currently taking certain MS disease-modifying treatments, depending on the specific medication and required waiting period before enrolment (confirm with trial site for details on specific medications and washout periods)
• People who have relapsing-remitting MS (a different form of MS)
• People who have primary progressive MS (another different form of MS)
• People who have hepatitis B or hepatitis C, or whose blood tests show certain markers associated with these infections
• People who have HIV infection, or whose screening blood test is positive for HIV
• People who have active or latent (hidden) tuberculosis, or whose tuberculosis screening test comes back positive
• People who have another active infection that could be made worse by the trial treatment
• People whose blood tests show abnormally low levels of certain blood cells (white blood cells, a specific type of white blood cell, or platelets)
• People whose blood tests show certain liver function values or a haemoglobin level outside the ranges allowed by the trial (confirm with trial site)
• People who have not completed a full COVID-19 vaccination course at least 6 weeks before joining, or who have received any vaccine within the last 6 weeks
• People who have not completed the required cancer screening tests, or where those screening tests have raised concerns that need further investigation
• People who do not have detectable antibodies against the chickenpox virus (Varicella zoster) in their blood, and who have not had two doses of the chickenpox vaccine with the last dose given at least 6 months before enrolment
• People who are currently using blood-thinning or anti-clotting medications (taken by mouth or injection), other than low-dose aspirin

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