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 aged 18 to 65 years old at the time of screening.
• People who have been diagnosed with multiple sclerosis (MS).
• People with relapsing-remitting MS (RRMS) who are currently on a disease-modifying therapy (DMT — a type of medication used to manage MS).
• People with progressive MS who are not currently on a disease-modifying therapy.
• People with RRMS whose MS medication has been stable, meaning no MS relapse (flare-up) in the month before screening. Note: people taking certain MS medications (tecfidera, cladribine, ocrelizumab, alemtuzumab, fingolimod, or natalizumab) may be considered for inclusion, but only at the careful discretion of the Chief Investigator, due to the effects these drugs can have on the immune system.
• People who have had a specific test on their spinal fluid (called an oligoclonal bands test, or OCB) that returned a positive result — either from a past test or one done at screening.
• People who are willing and able to give written consent to participate and follow the study requirements (consent can be withdrawn at any time without affecting future medical care).
• People who agree to use effective contraception during the study and for 90 days after the last dose of study medication, as follows:
  • Female participants must be post-menopausal for at least one year (confirmed by blood tests), or have had a surgical procedure that means they cannot become pregnant, or agree to use two reliable methods of contraception at the same time, or agree to complete abstinence from sex if that is their normal lifestyle. Note: methods such as calendar tracking, the withdrawal method, or other periodic abstinence methods are not accepted.
  • Male participants — even those who have had a vasectomy — must agree to use a barrier method of contraception (such as a condom) throughout the study and for 90 days after the last dose, or agree to complete abstinence if that is their normal lifestyle. The same note about periodic abstinence applies.
• People whose blood test results at screening meet the following thresholds (these are measures of blood cell counts and organ function):
  • A healthy enough level of a type of white blood cell called neutrophils.
  • A healthy enough platelet count (platelets help blood clot).
  • Liver function markers (bilirubin, ALT, and/or AST) within an acceptable range.
  • Kidneys working well enough, based on a calculated measure of kidney function.

Who may not be able to join:

• People with a very high level of MS-related physical disability at screening (confirm with trial site for the specific score threshold).
• People who have had an MS relapse within one month before screening.
• People who are pregnant or breastfeeding at the time of screening.
• People who have had major surgery within 14 days before the study baseline visit.
• People with any significant active cancer or serious infection, including a possible diagnosis of a blood-related cancer called multiple myeloma, as assessed by the trial investigators.
• People who have had a serious infection requiring intravenous (IV) antibiotics within 14 days before joining the study. Urinary tract infections must be treated before the baseline visit and may delay the start of the study for that person.
• People with serious, currently uncontrolled heart or cardiovascular conditions, including uncontrolled high blood pressure, uncontrolled irregular heartbeat, heart failure with symptoms, unstable chest pain (angina), or a heart attack within the past 6 months.
• People who have taken certain medications known to interfere with the study drug (including rifampin, rifapentine, rifabutin, carbamazepine, phenytoin, or phenobarbital) within 14 days before the first dose, or who are using St. John's Wort.
• People with a history of active hepatitis B or C, HIV, or a positive tuberculosis (TB) test. Note: if TB is detected and the TB medical team decides to treat it as latent (inactive) TB, eligibility may be reassessed after that treatment is completed.
• People with a serious medical or psychiatric condition that, in the investigator's opinion, could interfere with completing the study treatment.
• People with a known stomach or bowel condition, or who have had a bowel procedure, that could affect how the study medication is absorbed or tolerated — including difficulty swallowing.
• People who have been diagnosed with or treated for cancer within the past 2 years, or who have any remaining signs of a previously diagnosed cancer. People who have had a non-melanoma skin cancer or a very early-stage cancer that has been fully removed by surgery are not excluded.
• People who have significant nerve damage in their hands or feet (peripheral neuropathy) at a certain level of severity at screening (confirm with trial site for specific grade details).
• People who have taken part in another clinical trial involving an investigational, licensed, or alternative medicine product within 30 days of screening, or who plan to do so during this study. Taking part in non-interventional studies (such as questionnaire or observational studies) is allowed.
• People who have previously been treated with the study drug ixazomib, or who have taken part in a previous study involving ixazomib (whether or not they received the active drug).
• People with a known allergy to the study medication or any of its ingredients.
• People who have any pre-existing condition affecting the brain or central nervous system, other than MS.
• People with a history of uncontrolled drug or alcohol misuse within the 6 months before screening.

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