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

This study is testing KPL-387, given by injection, to see if it's a safe and effective treatment for recurrent pericarditis (inflammation of the sac around the heart that keeps coming back). You might be able to join if you are 18 to 80 years old, have recurrent pericarditis, and are still having symptoms despite taking standard treatments like NSAIDs (non-steroidal anti-inflammatory drugs) or colchicine. The study aims to find out how well KPL-387 controls pain and inflammation, and if it can reduce how often pericarditis comes back. We don't have information about the current recruitment status of this study.

Study design
This is an interventional study with a planned enrollment of 165 participants, divided into three parts: Phase 2, Phase 3, and a Long-Term Extension. Participants will receive either KPL-387 or a placebo (an inactive substance) by subcutaneous injection.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will measure time to treatment response up to Week 24 in Phase 2, and time to pericarditis recurrence in Phase 3. For the Long-Term Extension, the annualized rate of recurrence will be assessed for up to 24 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07010159

Phase 2/3 Study of Participants With Recurrent Pericarditis Evaluating the Efficacy and Safety of KPL-387

Recruiting
PHASE2Ages 18–80InterventionalTreatment
Kiniksa Pharmaceuticals International, plc
~325 participants
Updated 2026-08-26 on ClinicalTrials.gov
What's tested:KPL-387Placebo

At a glance

Recruiting sites
61 of 63 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Phase 2: Time to Treatment Response by Week 24
Measured over From Baseline up to Week 24
+2 more outcomes measured

Conditions

Pericarditis
Pericarditis Acute
Recurrent Pericarditis

Explore related trials

Pericarditis

Where it's being run

63 sites across 26 states
Italy10
France6
Spain5
California4
United Kingdom4
Missouri3
Virginia3
Greece3

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

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)

Exclusion

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 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.
Phase 2 and 3: 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.
Phase 2 and 3: Has had an organ transplant (except corneal transplant performed more than 3 months prior to first study drug administration).
Phase 2 and 3: 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

  • Phase 2: Time to Treatment Response by Week 24From Baseline up to Week 24
  • Phase 3: Time to Pericarditis RecurrenceFrom Baseline in the RW Period
  • Long-Term Extension: Annualized rate of Pericarditis RecurrenceUp to 24 Months