A Phase 3, Randomized, Double-blind, Efficacy and Safety Study Comparing Orelabrutinib to Placebo in Patients With Primary Progressive Multiple Sclerosis
This research study is looking at a new medicine called orelabrutinib for people who have Primary Progressive Multiple Sclerosis (PPMS). In PPMS, symptoms gradually get worse over time. The study aims to find out if orelabrutinib can help to slow down this progression compared to a placebo, which is a tablet that looks the same but contains no active medicine. This is a special type of study called a 'Phase 3' trial, which means it’s one of the final steps to see if the medicine is safe and works well before it could potentially be made available more widely. Researchers will be carefully checking how participants' disability changes over time.
At a glance
What is this study about?
This clinical trial is designed to investigate a new medication called orelabrutinib for individuals living with Primary Progressive Multiple Sclerosis (PPMS). PPMS is a form of multiple sclerosis where symptoms gradually worsen from the start, rather than coming and going in relapses. The main goal of this study is to see if orelabrutinib can help to slow down or stop the progression of disability that is typical in PPMS.
To ensure we get clear results, some participants will receive orelabrutinib, while others will receive a 'placebo.' A placebo is a tablet that looks identical to the study medicine but doesn't contain any active drug. This helps researchers fairly compare the new medicine's effects. Neither the participants nor the doctors will know who is receiving which treatment during the study – this is called a 'double-blind' study and helps make the results as unbiased as possible.
The researchers will be carefully monitoring participants to see if their disability gets worse over time. They'll use specific measurements, such as how someone's walking ability changes or how well they can use their hands, to track any progression. The study is particularly interested in whether any worsening of symptoms is confirmed and lasts for at least 12 weeks. This detailed approach helps us understand if orelabrutinib could be a useful new treatment option for PPMS.
Key takeaways
- This study is testing a new medicine for Primary Progressive MS (PPMS).
- It aims to see if the medicine can slow down the worsening of MS symptoms.
- Participants will receive either the new medicine or a dummy pill (placebo).
- It's a 'double-blind' study, so no one knows who gets what treatment until later.
- Regular health checks and tests will monitor your MS progression.
- You can discuss with your doctor if this study might be right for you.
Who may be eligible?
This study is looking for adults who have been diagnosed with Primary Progressive Multiple Sclerosis (PPMS). Your doctors will confirm if this is the right study for you based on specific criteria related to your PPMS diagnosis and overall health.
Both men and women are welcome to take part in this research. You must be at least 18 years old to be considered for the study. There is no upper age limit, meaning older adults with PPMS can also participate if they meet all other requirements.
As part of the screening process, the study team will carry out some checks to make sure it's safe and appropriate for you to join. This might include reviewing your medical history, current health, and any other medications you are taking.
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?
- Have you been diagnosed with Primary Progressive Multiple Sclerosis (PPMS)?
- Are you comfortable with regular clinic visits and health checks?
- Are you able to take tablets as instructed?
What does participation involve?
If you decide to join this study, you would be randomly assigned to receive either the study medicine (orelabrutinib) or a placebo (a dummy pill). Both tablets would look exactly the same.
Throughout the study, you would have regular visits to your study doctor or clinic. These visits will involve various tests and assessments to monitor your health, check for any changes in your MS symptoms, and see how you are responding to the treatment. These assessments might include physical examinations, speaking with you about your symptoms, and specific tests like measuring your walking speed or hand dexterity. You would also need to take the study tablets as instructed.
The total duration of your participation in this study would be decided by the researchers. All procedures, including the frequency of visits, exact tests involved, and how long you'd be taking the medication, would be fully explained to you before you make any decision to participate.
Potential risks and benefits
Locations (20)
- —UnverifiedItaly
- —UnverifiedFinland
- —UnverifiedBulgaria
- —UnverifiedGreece
- —UnverifiedBelgium
- —UnverifiedEstonia
- —UnverifiedPortugal
- —UnverifiedSpain
- —UnverifiedGermany
- —UnverifiedFrance
- —UnverifiedCzechia
- —UnverifiedSlovakia
Common questions
What is Primary Progressive Multiple Sclerosis (PPMS)?
PPMS is a type of MS where symptoms gradually get worse over time, rather than having clear attacks or relapses.
What is a 'placebo'?
A placebo is a 'dummy' tablet that looks just like the real medicine but contains no active drug. It helps researchers compare the effects of the new medicine fairly.
Will I know if I'm getting the active medicine or the placebo?
No, this is a 'double-blind' study, meaning neither you nor your study doctor will know which treatment you are receiving until after the study is over.
How long will the study last?
The total duration of the study will be explained in detail by the research team if you are eligible and interested in participating.
Can I stop participating in the study if I want to?
Yes, you can leave the study at any time, for any reason, without it affecting your usual medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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