IMpAct of CardiolRxTM oVer 6 months following IL-1 Blocker cessation in pERICarditis patients – MAVERIC: A randomized, double-blind, placebo-controlled trial
This study is called MAVERIC and it's looking into a new medicine called CardiolRx. It's for adults who keep getting pericarditis, which is when the protective sac around the heart becomes inflamed. Currently, some people take a medicine called an IL-1 blocker for this. This study wants to find out if CardiolRx can help stop pericarditis from coming back in the first six months after someone stops taking their IL-1 blocker. Half the people in the study will get CardiolRx, and the other half will get a dummy medicine (placebo). Neither the patients nor the doctors will know who is getting which, to make the results fair. The main goal is to see how many people stay free from pericarditis episodes during this time, and also to check if the new medicine is safe.
At a glance
What is this study about?
This study, called MAVERIC, is all about helping people who suffer from recurrent pericarditis. Pericarditis is a condition where the thin, protective sac surrounding your heart, called the pericardium, becomes inflamed. When it's 'recurrent,' it means it keeps coming back, which can be very painful and disruptive to daily life. Many people who get recurrent pericarditis are treated with a type of medicine called an IL-1 blocker. This study aims to see if a new medicine, CardiolRx, can help prevent these painful episodes from returning once a person stops taking their IL-1 blocker.
To do this, the study will involve two groups of people. One group will receive the new medicine, CardiolRx, and the other group will receive a 'placebo.' A placebo looks just like the real medicine but doesn't contain any active drug – it's often a neutral substance like an oil with vitamin E, as described for this study. This is a common way to test new medicines fairly, because it helps researchers know if any changes people feel are truly due to the medicine itself or to other factors. Neither the patients nor the doctors involved will know who is getting the real medicine and who is getting the placebo until the study is over.
The main thing the researchers want to find out is how many people in each group stay free from a new episode of pericarditis for the first six months after stopping their IL-1 blocker. They will also be closely monitoring everyone for any side effects or changes in their health to make sure CardiolRx is safe. This is a 'Phase III' study, which means it's one of the final steps in testing a new medicine before it can potentially be made available to more people.
Key takeaways
- This study is for adults with recurrent pericarditis.
- It tests a new medicine called CardiolRx to prevent pericarditis from returning.
- The study compares CardiolRx to a dummy medicine (placebo).
- It aims to see if CardiolRx helps over 6 months after stopping another treatment.
- Participants will be closely monitored for health and any side effects.
Who may be eligible?
This study is looking for adults aged 18 or older. Both men and women can take part.
To be eligible, you must have been diagnosed with recurrent pericarditis and be currently receiving treatment with a medicine called an IL-1 blocker. The study aims to see if CardiolRx can help you when you stop this current treatment.
There might be other health conditions or medicines that would prevent you from joining, as is common with all clinical trials. The study team will check all these details carefully with 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 pericarditis that keeps coming back?
- Are you currently taking an 'IL-1 blocker' medicine for your pericarditis?
- Are you able to attend regular appointments for six months?
What does participation involve?
If you decide to take part in this study, you'll be involved for about six months. You would continue to see the study team regularly for check-ups and to provide blood samples. These visits will help the doctors monitor your health, check for any recurrence of pericarditis, and see how the study medicine is affecting you. You'll switch from your current IL-1 blocker to either the CardiolRx or the placebo medicine, which you'll take as directed.
During your visits, you'll be asked about any pain you're experiencing, and your blood will be tested to check for inflammation and liver function, among other things. They will also do heart tracings (ECGs) to monitor your heart's electrical activity. There will be samples taken to understand how your body processes the study medication (these are called PK samples). The total duration of the part of the study where they are checking if the medicine works is 24 weeks, or about 6 months.
Potential risks and benefits
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Common questions
What is pericarditis?
Pericarditis is when the protective sac around your heart gets inflamed or swollen, which can cause chest pain and other symptoms.
What is an IL-1 blocker?
An IL-1 blocker is a type of medicine often used to treat ongoing inflammation, like that caused by recurrent pericarditis.
What is a placebo?
A placebo is a dummy medicine that looks like the real thing but doesn't contain any active drug. It helps researchers compare how well the new medicine works.
Will I know if I'm getting the real medicine?
No, neither you nor your doctor will know whether you are getting the active medicine or the placebo during the study. This is called 'double-blinded.'
How long will the study last for me?
The main part of the study looking at how well the medicine works will last for about six months.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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