A Phase 3, randomized, double-blind, efficacy and safety study comparing SAR442168 to placebo in participants with primary progressive multiple sclerosis (PERSEUS)
This research study, called PERSEUS, is for people living with Primary Progressive Multiple Sclerosis (PPMS). The main goal is to test a new medicine, SAR442168, to see if it can help slow down the disease. Researchers will compare this new medicine to a dummy pill (placebo) to understand how well it works and if it's safe. They will track changes in your disability and look at other health markers over approximately six months. We hope this study will give us important information about potential new treatments for PPMS.
At a glance
What is this study about?
This study is a kind of research called a 'Phase 3 trial.' This means it's one of the final steps in checking if a new medicine works and is safe before it can be considered for wider use. The medicine being tested is called SAR442168, and it's for people who have Primary Progressive Multiple Sclerosis, often shortened to PPMS. PPMS is a form of MS where symptoms gradually worsen over time without periods of clear recovery.
The main aim of this study is to see if SAR442168 can help slow down the progression of disability in people with PPMS. To fairly test this, some people in the study will receive the new medicine, and others will receive a 'placebo.' A placebo looks just like the real medicine but contains no active drug. This helps researchers understand if any improvements are truly due to the medicine or just a natural change or expectation. Neither you nor your study doctor will know whether you are receiving the medicine or the placebo during the study.
We'll be looking carefully at several things to understand how well the medicine works. The most important measure is called '6-month composite Confirmed Disability Progression,' which means we'll check if your disability has worsened and stayed that way for at least six months. We'll also look at things like changes in your brain scans (MRI), how your memory and thinking might change, your quality of life, and various markers in your blood. Safety is also very important, so we’ll be closely monitoring for any side effects.
Key takeaways
- This study is testing a new medicine (SAR442168) for people with Primary Progressive MS.
- It aims to see if the medicine can slow down the disease's progression and if it's safe.
- Participants will receive either the new medicine or a dummy pill (placebo).
- The study involves regular visits, medical checks, and brain scans (MRI).
- You will be closely monitored for both the medicine's effects and any side effects.
Who may be eligible?
To join this study, you need to be an adult, aged 18 years or older. There is no upper age limit, meaning people of any adult age can potentially take part. The study is open to both men and women.
Beyond these basic requirements, there will be other specific medical criteria that your study doctor will need to check to make sure the study is right for you and safe for you to participate in. These details are important for ensuring the study results are clear and that all participants are treated safely.
For example, your doctor will check your exact diagnosis of Primary Progressive MS, your general health, and any other medications you might be taking. This is to make sure the study design fits your particular health situation.
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 18 years old or older?
- Do you have a diagnosis of Primary Progressive Multiple Sclerosis?
- Are you able to attend regular clinic appointments?
- Are you willing to potentially receive a placebo during the study?
What does participation involve?
If you decide to take part in this study, you will receive either the investigational medicine (SAR442168) or a placebo (a dummy pill). The study medicine or placebo is given as a pill. Your participation would involve several visits to the clinic over a period of time, where you will have various health checks and assessments. These may include physical examinations, blood tests, brain scans (MRI), and tests to check your thinking and memory abilities.
You will need to take the study medication regularly as instructed. There will also be regular follow-up visits to monitor your health, any changes in your symptoms, and to check for any side effects. The total duration of your involvement in the study will be determined by the study design, but the primary assessment period for how the treatment affects disability progression is around six months.
Potential risks and benefits
Locations (19)
- —UnverifiedBelgium
- —UnverifiedFrance
- —UnverifiedAustria
- —UnverifiedCroatia
- —UnverifiedPortugal
- —UnverifiedHungary
- —UnverifiedPoland
- —UnverifiedNetherlands
- —UnverifiedItaly
- —UnverifiedBulgaria
- —UnverifiedDenmark
- —UnverifiedEstonia
Common questions
What is Primary Progressive Multiple Sclerosis (PPMS)?
PPMS is a type of MS where symptoms gradually get worse over time without periods of improvement or remission.
What is a placebo?
A placebo is a dummy pill that looks like the active medicine but contains no drug. It's used in studies to fairly compare the new medicine's effects.
Will I know if I'm getting the real medicine or the placebo?
No, neither you nor your study doctor will know whether you are receiving the active medicine or the placebo until after the study is complete. This helps ensure the study results are unbiased.
How long will the study last?
The main part of the study assessing the medicine's effect on disability progression is around six months, but overall participation might be longer, depending on the study design.
Can I leave the study at any time?
Yes, your participation is voluntary, and you can choose to leave the study at any time, for any reason, without it affecting your medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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