RecruitingPhase 2/3

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

United States, Canada, France165 participantsStarted 2025-07-25

Plain-language summary

This study is being done to demonstrate whether KPL-387 is an effective and safe treatment for recurrent pericarditis.

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Key Inclusion Criteria: * Phase 2 and 3: Has a diagnosis of recurrent pericarditis * Phase 2 and 3: Has signs and symptoms of recurrent pericarditis despite treatment with standard therapies * Phase 2 and 3: Weighs at least 40 kg * Phase 2: Taking NSAIDS and/or colchicine (in any combination) * Phase 3: Taking NSAIDs and/or colchicine and/or glucocorticoids (in any combination) Key Exclusion Criteria: * Phase 2 and 3: Has a diagnosis of pericarditis that is secondary to specific prohibited etiologies. * Phase 2 and 3: Has received an investigational drug during the 4 weeks before screening or is planning to receive an investigational drug at any time during the study. * Phase 2 and 3: Has a history of active or untreated, latent tuberculosis (TB) prior to screening. * Phase 2 and 3: Has a history of immunodeficiency. * Phase 2 and 3: Has a history of immunosuppression, including positive human immunodeficiency virus (HIV) test results. * Phase 2 and 3: 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. * Phase 2 and 3: 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). * Phase 2 and 3: Has a known or suspected current active infection or …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Since this trial is in Phase 2/3, meaning it's still building safety and effectiveness data, what do we know so far about KPL-387's safety profile compared to treatments I might already be eligible for, like colchicine or rilonacept?
2The Phase 2 part of this study is measuring whether patients respond to treatment by Week 24 — given how often my pericarditis has come back, does that timeline make sense for my situation, and what happens to me in the trial if I don't respond by then?
3The Phase 3 part is tracking how long it takes for pericarditis to come back after treatment — does that mean I could be in this study for a long time, and how would that affect my other care or my daily life?
4There's a long-term extension phase measuring how often recurrences happen over time — if I enroll and the drug seems to be helping, would I be able to stay on it, or could I be switched off it at some point during the study?
5Would you recommend I try any standard therapies first before considering an experimental treatment like KPL-387, or does my history of recurrences make me a candidate where this trial might be worth discussing sooner?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Phase 2: Time to Treatment Response by Week 24

Timeframe: From Randomization up to Week 24

Phase 3: Time to Pericarditis Recurrence

Timeframe: From first administration of study drug in the RW Period

Long-Term Extension: Annualized rate of Pericarditis Recurrence

Timeframe: Up to 24 Months

Trial details

NCT IDNCT07010159

SponsorKiniksa Pharmaceuticals International, plc

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-12-31

Contact for this trial

Clinical Project Manager

781-431-9100 clinicaltrials@kiniksa.com

View on ClinicalTrials.gov More Pericarditis trials

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.