RecruitingPHASE2, PHASE3INTERVENTIONAL

Phase 2/3 Study of KPL-387 in Recurrent Pericarditis

This research study is looking at a new medicine called KPL-387 for people who have recurrent pericarditis. This is a condition where the sac around the heart becomes inflamed repeatedly, causing chest pain and other symptoms. The main goal is to find out if KPL-387 is safe and effective in treating this condition, helping to reduce pain and inflammation, and stopping it from returning. The study involves different stages to test various doses of the medicine and then confirm how well it works over a longer period. Some people will receive KPL-387, while others will receive a placebo (a dummy treatment) to compare the effects.

At a glance

Status

Recruiting

Phase

PHASE2, PHASE3

Sponsor

Kiniksa Pharmaceuticals International, plc

Enrolment target

165

Start

25 Jul 2025

Estimated completion

31 Dec 2029

Pericarditis Pericarditis Acute Recurrent Pericarditis

What is this study about?

This study is investigating a new medication called KPL-387 for people who experience recurrent pericarditis. Pericarditis is a condition where the thin, protective sac surrounding your heart becomes inflamed, often causing sharp chest pain. When it's 'recurrent,' it means these inflammations keep coming back, which can be very distressing and impact daily life. We want to understand if KPL-387 can effectively reduce this inflammation and pain, and crucially, if it can help prevent these episodes from happening again.

The study is divided into several parts. Initially, we'll look at different amounts (doses) of KPL-387 in a smaller group of people to see which dose works best to control pain and inflammation during a flare-up. Once we've identified the most promising dose, we'll then test it in a larger group of participants to confirm its effectiveness in treating recurrent pericarditis and lowering the chance of it returning. There's also a long-term part of the study for those who complete the initial stages, to see how well KPL-387 works over a longer time to keep the condition under control.

Throughout all parts of the study, we'll also be carefully checking for the safety of KPL-387 and how well people tolerate it. We'll be doing blood tests to see how much of the medicine is in the body and how it affects markers of inflammation and immune activity. This will give us a complete picture of how KPL-387 works and whether it could be a helpful new treatment option for people with recurrent pericarditis.

Key takeaways

This study is for people with recurrent pericarditis.
It's testing a new medicine called KPL-387.
Some participants will get the new medicine, others a placebo.
The study aims to see if KPL-387 is safe and helps reduce pain, inflammation, and prevents recurrences.
There are different parts to the study, including a long-term follow-up option.
Your participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To join this study, generally, you need to be aged between 18 and 80 years old and have a diagnosis of recurrent pericarditis. This means your pericarditis has come back, and you're currently experiencing symptoms despite already taking standard medications for it. You should also weigh at least 40 kg (about 6 stone 4 lbs).

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 recently taken part in another research study involving a new medication. You also wouldn't be able to join if you have certain infections like active or untreated tuberculosis, or conditions that affect your immune system, such as HIV. We also can't include people who have had certain types of cancer within the last five years, or severe infections recently. The study also cannot include individuals who have had an organ transplant.

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 between 18 and 80 years old?
Have you been diagnosed with recurrent pericarditis?
Are you currently experiencing symptoms of recurrent pericarditis despite standard treatments?
Do you weigh at least 40 kg (about 6 stone 4 lbs)?
Have you recently participated in another clinical trial for a new drug (within the last 4 weeks)? (If yes, you likely can't join)
Do you have certain medical conditions like active tuberculosis or HIV? (If yes, you likely can't join)

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be randomly assigned to either receive the study medicine, KPL-387, or a matching dummy treatment (placebo). This means neither you nor your study doctor will know which one you're getting. You would have regular visits to the clinic for various assessments, which might include thorough physical exams, blood tests, and heart monitoring. You'd also need to take the study medication as instructed. The total time you'd be involved in the study would depend on which part you join. For example, the initial dose-finding and confirmation parts involve a series of visits, and if you complete these, you might have the option to join the longer-term part of the study for continued care and monitoring.

Potential risks and benefits

Taking part in any clinical trial involves potential benefits and risks. A potential benefit of this study is that KPL-387 might help improve your pericarditis symptoms and prevent future flare-ups, possibly better than your current treatments. However, it's also possible that KPL-387 may not work for you, or you might receive the placebo. As with any new medicine, there's always a chance of side effects, which the study team will carefully monitor. You will be told about all known risks before you decide to take part. It's very important to remember that joining is completely voluntary, and you are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (56)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Investigational Site 018
Verified postcode
Gilbert, United States· Recruiting
Investigational Site 053
Verified postcode
Phoenix, United States· Recruiting
Investigational Site 030
Verified postcode
Los Angeles, United States· Recruiting
Investigational Site 008
Verified postcode
San Francisco, United States· Recruiting
Investigational Site 044
Verified postcode
Santa Monica, United States· Recruiting
Investigational Site 016
Verified postcode
Westminster, United States· Recruiting
Investigational Site 001
Verified postcode
Columbus, United States· Withdrawn
Investigational Site 004
Verified postcode
Chicago, United States· Recruiting
Investigational Site 014
Verified postcode
Indianapolis, United States· Recruiting
Investigational Site 002
Verified postcode
Overland Park, United States· Withdrawn
Investigational Site 043
Verified postcode
Baltimore, United States· Recruiting
Investigational Site 054
Verified postcode
Boston, United States· Recruiting

Common questions

What is recurrent pericarditis?

It's when the protective sac around your heart gets inflamed, causing chest pain, and these episodes keep happening again and again.

What is KPL-387?

KPL-387 is the new medication being tested in this study to see if it can help treat recurrent pericarditis.

What is a placebo?

A placebo is a 'dummy' treatment that looks just like the real medicine but contains no active drug. It helps us compare the effects of the new medicine.

How long will the study last?

The length of your participation will depend on which part of the study you join, but there's also an option for long-term follow-up.

Can I leave the study if I change my mind?

Yes, you can leave the study at any time, for any reason, without affecting your regular medical care.

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.