Phase 2 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:

• You have been diagnosed with ALS (either sporadic or familial), confirmed by recognized diagnostic standards called the revised El Escorial criteria.
• You are between 18 and 80 years old.
• Your ALS symptoms started no more than 28 months before the screening visit.
• Your ALS function rating score (a standard measure of how ALS affects daily tasks) is 35 or higher at screening.
• Your ALS has been progressing at a moderate rate — not too slowly and not too quickly — based on that same rating scale.
• Your lung breathing capacity is at least 70% of what is expected for someone your age and size.
• If you take riluzole (an ALS medication), you have been on a stable dose for at least 30 days before screening and plan to stay on that dose — or you are willing to not start it during the trial.
• If you take edaravone (RADICAVA®), you have completed at least one full treatment cycle before screening and plan to stay on that dose — or you are willing to not start it during the trial.
• If you take tofersen (QALSODY®), you have been on it for at least 90 days before screening and plan to stay on that dose — or you are willing to not start it during the trial.

Who may not be able to join:

• You have another significant, unstable medical, surgical, or psychiatric condition (other than ALS), including active infections needing treatment, as judged by the study doctor.
• You are currently having thoughts of suicide with a plan, or have attempted suicide in the past 12 months.
• Your liver enzyme levels (called ALT or AST) are more than three times higher than the normal range.
• Your kidneys are not filtering blood well enough (based on a standard kidney function measurement falling below a certain level).
• You have a pre-existing lung condition such as chronic obstructive pulmonary disease (COPD), or significant breathing problems, as judged by the study doctor.
• You have a significant history of heart problems, including a weakened pumping function, abnormal heart wall movement, or coronary artery disease.
• You have ever received an organ transplant.
• You have tested positive for tuberculosis (TB, indicating a latent/hidden infection) or for viral hepatitis.
• You have received a medication called abatacept within the past 75 days.
• You have received a medication called interleukin-2 (IL-2) within the past 30 days.
• You are currently taking or expected to take immune-suppressing medications (such as cyclosporine, sirolimus, tacrolimus, mycophenolate mofetil, or long-term steroids) during the study.
• You are planning to receive a live vaccine during the study or within 3 months of stopping the trial.
• You are currently in another clinical trial, or have taken an experimental medication or used an experimental device within the past 30 days (or longer, depending on the medication).
• You have previously taken part in any study involving COYA 302.
• You have an autoimmune condition that is not well controlled.
• You have a long-term central catheter (a tube placed into a large vein) already in place.

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