A Phase 2a Study of SUN-627 to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Impact on Measures of Neuroinflammation in the Central Nervous System in Participants With Non-Active Progressive Multiple Sclerosis (SPMS/PPMS)
This research study is about a new medicine called SUN-627 for people living with non-active progressive Multiple Sclerosis (MS), specifically Primary Progressive MS or non-active Secondary Progressive MS. The main goal is to check how safe the medicine is and if people can take it without too many problems. Researchers will also look at how the body handles the medicine and whether it can help calm down inflammation in the brain. They will be checking for any side effects and serious problems throughout the 16-week study period. They will also take blood samples, brain fluid samples, and use brain scans to look for changes in inflammation after 12 weeks of treatment.
At a glance
What is this study about?
This study is looking into a new potential treatment called SUN-627 for people who have certain types of Multiple Sclerosis (MS). Specifically, it's for those with 'non-active progressive MS,' which includes Primary Progressive MS and non-active Secondary Progressive MS. These types of MS mean the condition is steadily getting worse over time, but without new flare-ups or relapses that cause new symptoms.
The main aim of this study is to understand if SUN-627 is safe to use and if people can take it without experiencing too many unwanted side effects. The researchers will be closely monitoring everyone for any problems that might come up during the study. They also want to learn how the medicine behaves in the body and if it can help reduce inflammation within the brain and spinal cord, which is a key part of MS.
By carefully checking for side effects, serious problems, and measuring changes in the body and brain over 16 weeks, the researchers hope to gather important information about SUN-627. This information will help them decide if this new medicine could be a helpful treatment option for people with these forms of progressive MS in the future.
Key takeaways
- The study is for a new medicine called SUN-627 for progressive MS.
- It focuses on safety, how the body uses the medicine, and brain inflammation.
- The study lasts 16 weeks, with regular health checks and tests.
- It's for adults (18+) with non-active Primary or Secondary Progressive MS.
- Participation involves blood tests, brain fluid samples, and MRI scans.
Who may be eligible?
To be considered for this study, you need to be an adult aged 18 or older. Both men and women can take part.
The study is specifically looking for people who have been diagnosed with certain types of progressive Multiple Sclerosis. This includes Primary Progressive MS (PPMS) or Secondary Progressive MS (SPMS) where your condition is considered 'non-active,' meaning you haven't had recent flare-ups or new symptoms that usually happen with active MS.
There will be other specific medical checks and requirements that the study doctors will go through with you to make sure this study is the right fit and safe for you.
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 MS?
- Or have you been diagnosed with Secondary Progressive MS that is currently 'non-active' (no recent relapses)?
- Are you able to attend appointments at the study clinic?
- Are you comfortable with blood tests, brain fluid samples, and MRI scans?
What does participation involve?
If you decide to take part in this study, you would receive the study medicine, SUN-627. The main part of the study lasts for 16 weeks. During this time, you would have regular visits to the study clinic. These visits will involve various tests and assessments to check your health, how you're feeling, and how the medicine is affecting your body. This includes physical examinations, blood tests, samples of fluid from around your brain and spinal cord (lumbar puncture), and brain scans (MRI).
These tests help the doctors keep a close eye on your health and check for any side effects. After the 12-week treatment period, there will be further follow-up to monitor your progress until the end of the 16-week study. The study team will explain the exact schedule of visits and what each visit will involve in detail.
Potential risks and benefits
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Common questions
What is SUN-627?
SUN-627 is a new medicine being tested in this study to see if it can help people with certain types of progressive MS by reducing inflammation.
What does 'non-active progressive MS' mean?
It means your MS is steadily getting worse over time without new flare-ups or symptoms that get worse quickly, like in a relapse.
How long will I be in the study?
The main part of the study where your health will be monitored, and you might receive the medicine, will last for 16 weeks.
What kind of tests will I have?
You'll have regular health checks, blood tests, brain fluid samples (lumbar punctures), and MRI scans of your brain.
Can I leave the study if I change my mind?
Yes, you can choose to stop participating in the study at any time, and it won't affect the care you receive from your doctor.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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