RecruitingPHASE2INTERVENTIONAL

Transition to KPL-387 Monotherapy Dosing & Administration Study

This study is for people in the UK who have recurrent pericarditis, a heart condition causing chest pain. It explores how effectively and safely patients can switch from their current treatments, like anti-inflammatory drugs or other heart medicines, to a new medicine called KPL-387. Researchers want to see if KPL-387 can be used on its own to manage controlled pericarditis. They will monitor chest pain, physical signs, and blood tests to check how well the new drug works and if there are any side effects. The study involves taking KPL-387 for up to 16 weeks, with an option to continue in a longer-term part of the study.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Kiniksa Pharmaceuticals International, plc

Enrolment target

Start

25 Mar 2026

Estimated completion

31 Dec 2029

Recurrent Pericarditis Heart Diseases Pericarditis

What is this study about?

This study aims to discover the best way to switch patients with recurrent pericarditis from their current medications to a new drug called KPL-387. Recurrent pericarditis is a condition where the sac around your heart (the pericardium) becomes inflamed again and again, causing chest pain. Current treatments often include anti-inflammatory drugs, colchicine, or steroids, and sometimes other specialist medicines. This study wants to find out if KPL-387 can be used as a 'monotherapy,' meaning it's the only drug you need for your pericarditis, once your condition is under control.

The main goal is to make sure this switch is both safe and effective. Researchers will carefully check how well KPL-387 works in managing your symptoms and preventing flare-ups, while also looking out for any side effects. The study will monitor various aspects of your health throughout this process. Finding a successful way to transition to KPL-387 could offer a new, simpler treatment option for people living with this ongoing heart condition.

After the initial part of the study, which lasts up to 16 weeks, there's an option for participants to continue receiving KPL-387 in a longer-term extension study. This extension will help researchers understand the effects of KPL-387 over a longer period, potentially up to two years. This is important for understanding the full benefits and risks of the medicine, and could pave the way for it to become more widely available.

Key takeaways

This study evaluates a new drug, KPL-387, for recurrent pericarditis.
It aims to see if KPL-387 can replace your current pericarditis medications.
The study involves up to 16 weeks of KPL-387, with an optional longer-term extension.
You'll have regular check-ups to monitor your symptoms and the drug's effects.
Participation requires your pericarditis to be currently well-controlled and stable.

Who may be eligible?

To join this study, you need to be an adult between 18 and 80 years old who has recurrent pericarditis that is currently well-controlled. This means your chest pain should be mild (a pain score of 3 or less) and a specific blood test (CRP) should be low. You also need to have been receiving standard treatments for your pericarditis for at least three months and currently be on stable doses of drugs like anti-inflammatory medicines, colchicine, steroids, or other specific heart medicines.

There are also some reasons why you might not be able to join. For example, if your pericarditis is caused by certain other specific health problems, or if you've had a pericarditis flare-up in the last three months. You also can't take part if you've recently been in another medical study or plan to be during this one. Certain serious health conditions like active tuberculosis, a history of problems with your immune system, or a recent history of cancer (with some exceptions) would also prevent you from participating. Frequent or serious infections could also make you ineligible.

Quick self-check

Are you between 18 and 80 years old?
Do you have recurrent pericarditis that is currently well-managed, with mild or no chest pain?
Have you been on stable pericarditis treatment for at least 3 months?
Have you not had a pericarditis flare-up in the last 3 months?
Do you have no history of certain serious conditions like active TB or recent cancer?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you join, you'll receive the study drug KPL-387. For the first part of the study, you'll take KPL-387 for up to 16 weeks. Throughout this time, you'll have regular visits where the study team will ask about your chest pain, do physical checks (like listening to your heart), and take blood tests to see how your pericarditis is doing and how the treatment is affecting you. You'll also fill out questionnaires about your pain.

After 16 weeks, if you meet the criteria and wish to continue, you may be able to join a longer-term part of the study. This extension could last up to two years, and you'd continue to have regular check-ups to monitor the drug's long-term effects. If you choose not to join the extended study, or if the initial study ends for you, you'll have a final visit and then be followed up for your safety for eight weeks after your last dose of KPL-387. The total duration of your active participation will depend on whether you join the extended study and how long you remain in it.

Potential risks and benefits

Taking part in a study like this might offer potential benefits, such as gaining access to a new medication (KPL-387) that could help manage your recurrent pericarditis. You'll also receive close medical attention and monitoring throughout the study. However, there are potential risks, as KPL-387 is an investigational drug, meaning its full effects and side effects are still being studied. You might experience side effects, and the drug may not work for you as expected. It's important to remember that participation is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (23)

Investigational Site 014
Los Angeles, United States· Recruiting
Investigational Site 002
Santa Monica, United States· Recruiting
Investigational Site 013
Chicago, United States· Recruiting
Investigational Site 011
New York, United States· Recruiting
Investigational Site 003
New York, United States· Recruiting
Investigational Site 009
Cincinnati, United States· Recruiting
Investigational Site 005
Austin, United States· Recruiting
Investigational Site 006
Houston, United States· Recruiting
Investigational Site 004
Charlottesville, United States· Recruiting
Investigational Site 001
Norfolk, United States· Recruiting
Investigational Site 008
Richmond, United States· Recruiting
Investigational Site 010
Ottawa, Canada· Recruiting

+11 more sites — see the official record for the full list.

Common questions

What is recurrent pericarditis?

It's a condition where the protective sac around your heart, called the pericardium, becomes inflamed repeatedly, causing chest pain and other symptoms.

What is KPL-387?

KPL-387 is a new medication being tested in this study to see if it can help manage recurrent pericarditis on its own.

How long will I be in the study?

The initial part of the study lasts up to 16 weeks, with an option to join a longer-term extension that could last up to two years.

Will I still take my regular medication?

The study looks at transitioning from your current medications to KPL-387 as a single treatment, so your existing medicines would be gradually reduced or stopped under medical guidance.

What does 'well-controlled' pericarditis mean?

It means your symptoms, like chest pain, are mild, and certain blood test results that show inflammation are low.

How to find out more

Clinical Project Manager

clinicaltrials@kiniksa.com 781-431-9100 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.