Phase 4 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 have had at least one clinical episode that meets the 2017 McDonald criteria for early Multiple Sclerosis (MS), confirmed through clinical assessment, MRI, or a specific spinal fluid test (confirm with trial site)
• People whose MS symptoms first appeared no more than 3 years before joining the trial
• Women who could become pregnant must agree to either avoid heterosexual intercourse or use reliable contraception (such as tubal ligation, partner sterilisation, hormonal contraceptives that stop ovulation, or a hormonal or copper IUD) during the treatment period and for at least 6 months after the last dose — note that periodic methods (such as calendar tracking) and withdrawal are not accepted, and barrier methods must also include a spermicide

Who may not be able to join:

• People who are unwilling or unable to give written consent or follow the study requirements
• People who have been diagnosed with primary progressive MS, progressive relapsing MS, or secondary progressive MS
• People who have metal implants or electronic devices in their body, or any other condition that prevents them from having an MRI scan
• People with a history of other neurological conditions, including stroke, bleeding in or around the brain, brain or spinal cord tumours, certain infections or metabolic conditions affecting the spinal cord, genetic progressive brain disorders, sarcoidosis of the nervous system, or autoimmune diseases that affect the nervous system
• Women who are pregnant or breastfeeding — women who could become pregnant must have a negative pregnancy test at the screening stage
• People who have another medical condition that requires ongoing treatment with steroids or immune-suppressing medications
• People without adequate vein access for blood draws or infusions
• People with a history of severe allergic reactions (including anaphylaxis) to certain types of antibody-based medications
• People with significant uncontrolled medical conditions affecting the heart, lungs, kidneys, liver, hormonal system, or digestive system, where the trial doctor judges participation to be unsafe
• People with a moderate-to-severe level of heart failure (classified as NYHA Class III or higher) at the time of screening
• People with an active bacterial, viral, fungal, or other serious infection, or who have required hospitalisation or intravenous antibiotics within 4 weeks, or oral antibiotics within 2 weeks, before the first infusion
• People with active or chronic HIV, syphilis, or tuberculosis (TB)
• People with evidence of past or current hepatitis B infection (including previously treated hepatitis B), or untreated hepatitis C infection
• People with an active cancer or who are being monitored for cancer returning — exceptions may include certain treated skin cancers or cervical/uterine cancers removed with clear margins (confirm with trial site)
• People with a substance use disorder, including problematic alcohol or drug use within the past year that has significantly affected work, school, or home responsibilities
• People who have received a live or live-attenuated vaccine within 4 weeks before the first infusion
• People who cannot tolerate corticosteroids (steroids), including those with uncontrolled psychosis or a known allergy to steroid medications
• People who have previously taken or are currently taking certain MS disease-modifying treatments, including fingolimod, other S1P receptor modulators, cladribine, natalizumab, anti-CD20 therapies, alemtuzumab, or chemotherapy agents
• People who have taken fumarate medications within 30 days before certain pre-treatment assessments and the first infusion
• People currently taking or who have previously taken other immune-modifying therapies (unless reviewed and approved by the trial's safety committee), or who have undergone experimental MS procedures
• People who have taken systemic (whole-body) steroid medications within 4 weeks before certain screening tests, the screening MRI, or the first infusion
• People whose blood test results at screening fall outside acceptable ranges, including abnormal results for hepatitis B or C, syphilis, HIV, TB, kidney function, liver enzymes, immune protein levels, platelet count, haemoglobin, or white blood cell counts (confirm specific values with trial site)
• People with any other medical issue, physical finding, or lab result that the trial doctor believes could put them at risk or affect the quality of the study

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