SIZOMUS Safety of Ixazomib Targeting Plasma Cells in Multiple Sclerosis
This study, called SIZOMUS, is exploring a new treatment for Multiple Sclerosis (MS) called ixazomib. We're interested in whether this medication can reduce specific immune cells, called plasma cells, which are linked to MS. Participants will be given either ixazomib capsules or dummy capsules (placebo) for up to two years. The study aims to look at how safe ixazomib is and if it has any effect on the condition. We're looking for people with all types of MS, including Relapsing Remitting, Primary Progressive, and Secondary Progressive MS. This is an early-stage study, meaning we're still learning a lot about this potential new treatment.
At a glance
What is this study about?
This study, called SIZOMUS, is looking into a new medication for Multiple Sclerosis (MS) called ixazomib. You might be familiar with MS being an autoimmune condition where the body's immune system mistakenly attacks its own tissues. In MS, a common feature is the presence of special immune cells, called plasma cells, in the protective layers around the brain and spinal cord.
These plasma cells produce certain proteins (called oligoclonal bands or OCBs) which are often found in the fluid surrounding the brain and spinal cord in people with MS. Ixazomib is a drug that has successfully treated another condition where plasma cells are a problem, called multiple myeloma. We want to find out if ixazomib can also help reduce these plasma cells or the proteins they produce in people with MS.
If you take part, you'll receive either ixazomib capsules (the active drug) or matching dummy capsules (placebo) for up to two years. We'll be carefully checking your health and looking for changes in these proteins to understand if ixazomib is safe and if it could be a useful treatment for MS in the future.
Key takeaways
- This study investigates a new drug (ixazomib) for MS.
- It aims to see if ixazomib is safe and reduces certain MS markers.
- Participants will take capsules for up to 24 months.
- Open to adults aged 18-65 with various MS types.
- It's a 'blinded' study, meaning you won't know if you're taking the active drug or a placebo.
Who may be eligible?
To join this study, you need to be an adult between 18 and 65 years old with a diagnosis of MS. Both men and women can take part. If you have Relapsing Remitting MS, you must already be stable on your usual MS treatment. If you have Progressive MS, you should not be on any disease-modifying treatment.
A key requirement is that you must have a positive test result for 'oligoclonal bands' (OCBs) in the fluid around your brain and spinal cord. This result can be from a previous test or from one done as part of screening for this study. We also ask that you are able to understand and sign the consent form, and commit to following the study's instructions carefully.
For women who can become pregnant, you'll need to use two effective methods of contraception consistently throughout the study and for 90 days after your last dose. This also applies if you choose to abstain from sex, provided this is your usual lifestyle. Men must also use effective contraception. Certain existing MS treatments might affect your eligibility, so these will be discussed carefully with the study doctor.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you between 18 and 65 years old?
- Do you have a diagnosis of Relapsing Remitting, Primary Progressive, or Secondary Progressive MS?
- If you have Relapsing Remitting MS, are you on stable treatment (DMT)?
- If you have Progressive MS, are you NOT currently taking a disease-modifying treatment (DMT)?
- Have you had a positive test for 'oligoclonal bands' (OCBs) in your spinal fluid?
- Are you willing to use effective contraception if you could become pregnant or get someone pregnant?
What does participation involve?
If you decide to take part in this study, you will be given either ixazomib capsules or placebo capsules to take for up to 24 months (two years). You won't know whether you are taking the active drug or the placebo. During this time, you'll have regular visits to the clinic for health checks, blood tests, and potentially further tests of the fluid around your brain and spinal cord to see how the treatment is affecting you. We will monitor your health closely throughout the study period to ensure your safety.
Potential risks and benefits
Locations (1)
- Royal London Hospital, Barts Health NHS Foundation TrustVerified postcodeLondon, United Kingdom· Recruiting
Common questions
What is ixazomib and how does it work?
Ixazomib is a drug that targets certain immune cells called plasma cells. In MS, these cells are thought to contribute to the disease. We want to see if this drug can reduce their activity.
What's a 'placebo'?
A placebo is a dummy capsule that looks exactly like the study drug but contains no active medicine. It helps scientists compare the effects of the active drug accurately.
How long will the study last if I join?
If you join, you will be taking medication (either ixazomib or placebo) for up to 24 months, which is two years. There will also be follow-up visits.
Will I know if I'm getting the real drug or the placebo?
No, during the study you won't know whether you are receiving the active drug or the placebo. This is to ensure the study results are unbiased.
Are there any travel costs covered for study visits?
Details about reimbursement for travel or other expenses will be discussed with you by the study team.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.