Ongoing Clinical Trials for Pericarditis
Currently, there are 3 clinical trials investigating new treatments for pericarditis, a condition where the protective covering around the heart becomes inflamed repeatedly. These studies are taking place across several European countries and are testing different medications to help manage symptoms and prevent future episodes of inflammation.
Clinical trial locations
- France
- Germany
- Greece
- Italy
- Poland
- Spain
Study Comparing Anakinra and Prednisone for Children with Colchicine-Resistant Recurrent Pericarditis
This trial is specifically designed for children and teenagers between 8 months and 18 years old who are experiencing repeated episodes of inflammation around the heart. The study focuses on young patients whose condition has returned despite treatment with common medications.
Who can join:
To be eligible for this study, children must have experienced a relapse of the condition after an initial diagnosis. The inflammation may have occurred without a known cause or following heart procedures. Importantly, participants must have either not responded well to standard treatments such as non-steroidal anti-inflammatory drugs (NSAIDs) and colchicine, or experienced side effects that made it difficult to continue taking these medications. A parent or legal guardian must provide written consent, and the child must also agree to participate if they are old enough to understand.
Who cannot join:
Children who have not experienced a return of symptoms after their first treatment with colchicine and NSAIDs are not eligible. The study is also not suitable for those who are responding well to these medications after the first relapse, or for patients who can tolerate colchicine without problems. Only children within the specified age range can participate.
What the trial aims to discover:
The main goal is to determine whether Anakinra is more effective than steroids in controlling the disease and preventing further flare-ups in children who have not responded to first-line treatments. The study will monitor how quickly the inflammation is controlled, track the number of flare-ups during follow-up, and assess overall quality of life. Safety will be closely watched throughout the study period, which can last up to 24 weeks.
Investigational medications:
The trial compares two treatments. Anakinra is given as an injection under the skin and works by blocking a specific protein in the body that causes inflammation. Prednisone is a steroid taken in tablet form that helps reduce inflammation and suppress the immune system. Both medications aim to help control symptoms and prevent future episodes.
Study of cannabidiol (CardiolRx) in patients with recurrent pericarditis after stopping IL-1 blocker treatment
This study is for adults who have been successfully treated with IL-1 blocker medications but are now ready to stop this treatment. The research will test whether a medication called CardiolRx, which contains cannabidiol, can help prevent the return of inflammation after stopping the IL-1 blocker.
Who can join:
Participants must be at least 18 years old and have a history of repeated episodes of inflammation around the heart. They must currently be receiving IL-1 blocker treatment that is planned to be discontinued and have been on this medication for at least 12 months. Importantly, patients must have been free from any recurrence of the condition for at least 6 months and have been on a stable, unchanged dose of IL-1 blocker for at least 3 months. Before starting the study, pain levels must be 2 or less on a 0-10 scale, and blood tests measuring inflammation (C-Reactive Protein) must be less than 1.0 mg/dL. Both men and women must agree to use effective contraception during the study and for 2 months afterward.
Who cannot join:
The study excludes people with a history of severe allergic reactions, active infections, tuberculosis, liver or kidney disease, uncontrolled high blood pressure, or recent heart attack or stroke. Those with current cancer diagnosis, pregnancy, breastfeeding, or planning pregnancy cannot participate. People who have participated in other clinical trials within the past 30 days or have a history of substance abuse within the past year are also excluded.
What the trial aims to discover:
The study will determine if patients who are dependent on IL-1 blockers can successfully stop their current treatment while taking CardiolRx without experiencing another episode of inflammation. Over 24 weeks, participants will be monitored for signs of the condition returning, including chest pain and inflammation markers in the blood. The medication will be given daily as an oral solution, with doses calculated based on the patient’s weight.
Investigational medications:
CardiolRx is an experimental medication containing cannabidiol being studied to see if it can help prevent inflammation from returning after stopping IL-1 blocker therapy. IL-1 blockers are medications that work by blocking a protein called interleukin-1, which is involved in inflammation. The study aims to see if patients can stop using IL-1 blockers while taking CardiolRx instead.
Study of KPL-387 compared to placebo in patients with recurrent pericarditis
This large-scale trial studies the effectiveness and safety of KPL-387 in treating adults with repeated episodes of inflammation around the heart. The study is divided into three parts, with participants receiving either KPL-387 or placebo during different phases of the trial.
Who can join:
Participants must be between 18 and 80 years old and weigh at least 40 kilograms. They must have a history or current diagnosis of the condition with specific symptoms such as chest pain typical of inflammation, specific heart sounds, changes in heart electrical activity, or fluid around the heart. Eligible patients must have experienced at least their third episode of inflammation or have ongoing symptoms despite initial improvement. At the time of enrollment, they must have a pain level of 4 or higher on a 0-10 scale and elevated inflammation blood test results (CRP of 1.0 mg/dL or higher). Participants must be on stable doses of anti-inflammatory medications for at least 72 hours before starting the study and must be willing to follow specific medication guidelines during the trial.
Who cannot join:
People who have had heart surgery or cardiac trauma in the past 6 months cannot participate. The study also excludes those with active bacterial infection of the heart, pregnant or breastfeeding women, and people currently taking medications that could interact with the study drug. Other exclusion criteria include history of tuberculosis or serious infections, severe liver problems, uncontrolled high blood pressure, active cancer, significant kidney disease, current substance abuse, or mental health conditions that could interfere with participation.
What the trial aims to discover:
The main focus is on measuring how quickly patients respond to treatment and how long they can remain free from symptoms. Throughout the study, researchers will monitor participants’ pain levels and measure the amount of C-reactive protein in the blood to determine how well the treatment is working. The study will also track other signs using various heart tests and evaluate participants’ overall well-being using quality of life questionnaires. The trial includes an initial treatment phase lasting 24 weeks, a re-initiation phase if symptoms return, and a long-term extension that may continue until June 2028.
Investigational medication:
KPL-387 is an investigational medication being tested to evaluate how well it works in reducing inflammation and managing symptoms in patients who experience multiple episodes of the condition. The medication is given as a subcutaneous injection under the skin.
Summary
The three ongoing clinical trials for recurrent pericarditis demonstrate significant research activity across Europe, with Italy participating in all three studies, making it a central hub for this research. The trials reflect different approaches to managing this challenging condition: one focusing specifically on pediatric patients (children aged 8 months to 18 years), while the other two target adult populations.
Notable differences exist in the patient populations being studied. The pediatric trial focuses on children who have not responded to first-line treatments like colchicine and NSAIDs. One adult trial specifically targets patients who are ready to discontinue IL-1 blocker therapy after long-term use, while the third trial focuses on adults experiencing active episodes of recurrent inflammation.
The trials are testing three distinct medications: Anakinra (compared with Prednisone) in children, CardiolRx containing cannabidiol in adults transitioning off IL-1 blockers, and KPL-387 in adults with active disease. This variety of investigational treatments reflects ongoing efforts to find effective solutions for different patient groups and disease stages.
Geographically, the studies span six European countries: Italy, Greece, France, Poland, Germany, and Spain. The widespread distribution of trial sites, particularly in the KPL-387 study which operates in six countries, may improve access for patients seeking to participate in research aimed at finding better treatment options for this recurring inflammatory condition.
