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KPL-387 for Recurrent Pericarditis

This study is testing KPL-387, given by injection under the skin, for people with recurrent pericarditis (inflammation of the sac around the heart). The main goal is to see how well KPL-387 works and how safe it is when people switch from their current pericarditis medicines to KPL-387 alone. You might be able to join if you are 18 to 80 years old, have well-controlled recurrent pericarditis, and have a history of inflammation (CRP > 1 mg/dL) with past episodes. The study will look at how many people are free from pericarditis recurrence by 16 weeks and over a longer period. The study aims to enroll 80 participants, but its current recruitment status is unclear.

Study design
This is an interventional study with an unclear phase, planning to enroll 80 participants. It involves transitioning from current pericarditis therapies to KPL-387 monotherapy.
What's involved
You will receive KPL-387 for up to 16 weeks in the main part of the study. You will have study visits to check for symptoms, physical signs, and laboratory evidence of pericarditis activity, as well as treatment tolerability.
Compensation
Not stated in the trial record.
Follow-up
Participants may be eligible to continue in a Long-Term Extension study for up to 24 months after the initial 16-week period.

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NCT07288216

Transition to KPL-387 Monotherapy Dosing & Administration Study

Recruiting
PHASE2Ages 18–80InterventionalTreatment
Kiniksa Pharmaceuticals International, plc
~80 participants
Updated 2026-08-11 on ClinicalTrials.gov
What's tested:KPL-387

At a glance

Recruiting sites
41 of 41 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Posology: Proportion of participants free from Pericarditis Recurrence by Week 16
Measured over From first administration of study drug up to Week 16
+1 more outcome measured

Conditions

Recurrent Pericarditis
Heart Diseases
Pericarditis

Explore related trials

Pericarditis

Where it's being run

41 sites across 19 states
Italy5
Spain5
France4
Virginia3
Greece3
United Kingdom3
California2
New York2

Who to contact

Clinical Project Manager
[email protected]
781-431-9100
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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).

Exclusion

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.

What this trial measures

  • Posology: Proportion of participants free from Pericarditis Recurrence by Week 16From first administration of study drug up to Week 16
  • Long-Term Extension: Annualized rate of Pericarditis Recurrence through the end of the LTE.Up to 24 Months