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New shot aims to keep pericarditis Flare-Ups at bay

NCT ID NCT07288216

Disease control Sponsor: Kiniksa Pharmaceuticals International, plc Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Aug 12, 2026 · Updated 5 times

Summary

This study tests a new drug called KPL-387 in 80 people with well-controlled recurrent pericarditis (inflammation around the heart). The goal is to see if patients can safely switch from their current treatments to KPL-387 alone and still prevent flare-ups. The trial will measure how many people stay free of recurrence and track quality of life over time.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
KPL-387 (given as a shot under the skin)
What this could lead to
If successful, this could offer a new maintenance treatment option for people with recurrent pericarditis, potentially reducing flare-ups and reliance on standard therapies.
What could go wrong
This is an early Phase 2 study with only 80 participants, so results may not apply to everyone. The drug may not prevent recurrences better than current treatments, and side effects are still being studied.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 80 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2026

Expected to finish

Dec 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria: * Has well-controlled recurrent pericarditis (i.e., including having CRP \< 0.5 mg/dL within 14 days of Baseline and a pericarditis pain NRS score ≤ 3 at Baseline) * Has a documented history of CRP elevation (\> 1 mg/dL) associated with at least one prior acute pericarditis episode, whether the incident event or any pericarditis recurrence * Has received treatment for RP for at least 3 months prior to Baseline with standard therapy(ies) and is currently on a stable dosing regimen including NSAIDs and/or colchicine, and/or glucocorticoids or an IL-1 pathway inhibitor (anakinra or rilonacept). Key Exclusion Criteria: * Has a diagnosis of pericarditis that is secondary to specific prohibited etiologies * Has had a pericarditis recurrence in the last 3 months prior to Baseline * Has received an investigational drug during the 4 weeks before study drug administration or is planning to receive an investigational drug at any time during the study. * Has a history of active or untreated, latent tuberculosis (TB) prior to screening. * Has a history of immunodeficiency. * Has a history of immunosuppression, including positive human immunodeficiency virus (HIV) test results. * Has chest x-ray at Screening or within 12 weeks before first study drug administration, with evidence of malignancy, abnormality consistent with prior or active TB infection or active infection. * Has a history of malignancy of any organ system within the past 5 years before Screening (other than a successfully treated non-metastatic cutaneous squamous cell carcinoma or basal cell carcinoma and/or localized carcinoma in situ of the cervix). * Has a known or suspected current active infection or a history of chronic or recurrent infectious disease (\> 3 episodes in prior 12 months), including but not limited to, genitourinary infection, chest infection, sinusitis, or skin/soft tissue infection. * Has had a serious infection, has been admitted to the hospital for an infection, or has been treated for a documented infection requiring antibiotics for a documented infection within 2 weeks prior to first study drug administration. * Has had an organ transplant (except corneal transplant performed more than 3 months prior to first study drug administration). * In the Investigator's opinion, has any other medical condition that could adversely affect the subject's participation or interfere with study evaluations.

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Conditions

The condition(s) this trial relates to.

heart disorder idiopathic recurrent pericarditis pericarditis Recurrence

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Heart diseases Pericarditis Recurrent pericarditis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    41 sites in 10 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Investigational Site 001

    RECRUITING

    Norfolk, Virginia, 23507, United States

  • Investigational Site 002

    RECRUITING

    Santa Monica, California, 90404, United States

  • Investigational Site 003

    RECRUITING

    New York, New York, 10032, United States

  • Investigational Site 004

    RECRUITING

    Charlottesville, Virginia, 22903, United States

  • Investigational Site 005

    RECRUITING

    Austin, Texas, 78705, United States

  • Investigational Site 006

    RECRUITING

    Houston, Texas, 77030, United States

  • Investigational Site 007

    RECRUITING

    London, SE1 7EH, United Kingdom

  • Investigational Site 008

    RECRUITING

    Richmond, Virginia, 23284, United States

  • Investigational Site 009

    RECRUITING

    Cincinnati, Ohio, 45219, United States

  • Investigational Site 010

    RECRUITING

    Ottawa, Ontario, K1N 6N5, Canada

  • Investigational Site 011

    RECRUITING

    New York, New York, 10016, United States

  • Investigational Site 012

    RECRUITING

    London, EC1A 7BE, United Kingdom

  • Investigational Site 013

    RECRUITING

    Chicago, Illinois, 60611, United States

  • Investigational Site 014

    RECRUITING

    Los Angeles, California, 90048, United States

  • Investigational Site 015

    RECRUITING

    Barcelona, 08035, Spain

  • Investigational Site 016

    RECRUITING

    Madrid, 28850, Spain

  • Investigational Site 017

    RECRUITING

    Madrid, 28034, Spain

  • Investigational Site 018

    RECRUITING

    Valencia, 46015, Spain

  • Investigational Site 019

    RECRUITING

    Barcelona, 08017, Spain

  • Investigational Site 020

    RECRUITING

    Warsaw, 02-507, Poland

  • Investigational Site 021

    RECRUITING

    Milan, 20157, Italy

  • Investigational Site 022

    RECRUITING

    London, NW3 2QG, United Kingdom

  • Investigational Site 023

    RECRUITING

    Nea Ionia, 142 33, Greece

  • Investigational Site 024

    RECRUITING

    Voula, 166 73, Greece

  • Investigational Site 025

    RECRUITING

    Baltimore, Maryland, 21287, United States

  • Investigational Site 026

    RECRUITING

    Poitiers, 86000, France

  • Investigational Site 027

    RECRUITING

    Paris, 75013, France

  • Investigational Site 028

    RECRUITING

    Rochester, Minnesota, 55905, United States

  • Investigational Site 029

    RECRUITING

    Belgrade, 11040, Serbia

  • Investigational Site 030

    RECRUITING

    Belgrade, 1100, Serbia

  • Investigational Site 031

    RECRUITING

    Phoenix, Arizona, 85054, United States

  • Investigational Site 032

    RECRUITING

    Toulouse, 31400, France

  • Investigational Site 033

    RECRUITING

    Udine, 33100, Italy

  • Investigational Site 034

    RECRUITING

    Genoa, 16147, Italy

  • Investigational Site 035

    RECRUITING

    Athens, 115 28, Greece

  • Investigational Site 036

    RECRUITING

    Padua, 35143, Italy

  • Investigational Site 037

    RECRUITING

    Varese, 21100, Italy

  • Investigational Site 038

    RECRUITING

    Toulouse, 31400, France

  • Investigational Site 039

    RECRUITING

    Jacksonville, Florida, 32224, United States

  • Investigational Site 040

    RECRUITING

    Cleveland, Ohio, 44195, United States

  • Investigational Site 041

    RECRUITING

    Dresden, 01307, Germany

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