Home › Trials › NCT07010159

KPL-387 for recurrent pericarditis

A Phase 2/3 Efficacy and Safety Study of KPL-387 Treatment in Participants With Recurrent Pericarditis

Phase2; Phase3 Interventional Kiniksa Pharmaceuticals International, plc · NCT07010159

This trial tests whether KPL-387 can control pain and inflammation and lower the chance of future attacks in people having an acute episode of recurrent pericarditis despite standard treatment.

Quick facts

PhasePhase2; Phase3
Study typeInterventional
Enrollment165 (estimated)
Ages18 Years to 80 Years
SexAll
SponsorKiniksa Pharmaceuticals International, plc Industry-sponsored
Locations52 sites (Gilbert, Arizona and 51 other locations)
Trial IDNCT07010159 on ClinicalTrials.gov

What this trial studies

This phase 2/3 interventional trial enrolls participants with recurrent pericarditis who are experiencing an acute flare and assigns them to KPL-387 or placebo to determine the best dose and confirm effectiveness. Phase 2 compares different dosing regimens to identify the regimen taken forward, Phase 3 confirms efficacy for symptom control and reduction in recurrence risk, and an optional long-term extension follows participants to monitor durability of disease control. Safety, tolerability, blood drug concentrations, and blood markers of immune activity are measured throughout. Background therapy such as NSAIDs and colchicine (and glucocorticoids in Phase 3) is permitted per the protocol.

Who should consider this trial

Good fit: People who weigh at least 40 kg with documented recurrent pericarditis who are currently experiencing an acute flare despite treatment with NSAIDs and/or colchicine (and possibly glucocorticoids in Phase 3) and who can attend visits at a participating U.S. site would be typical candidates.

Not a fit: Patients whose pericarditis is due to specific excluded causes, those with active or untreated latent tuberculosis, immunodeficiency or immunosuppression, recent or planned use of other investigational drugs, or who cannot attend required site visits are unlikely to benefit from or be eligible for this protocol.

Why it matters

Potential benefit: If successful, KPL-387 could reduce pain and inflammation during flares and decrease how often recurrent pericarditis returns, potentially reducing reliance on long-term steroids or repeated treatments.

How similar studies have performed: Other biologic anti-inflammatory therapies have shown benefit in reducing symptoms and recurrences in prior recurrent pericarditis trials, so this approach has clinical precedent.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 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.

Where this trial is running

Gilbert, Arizona and 51 other locations

+2 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions PericarditisPericarditis AcuteRecurrent PericarditisRecurrenceRecurrentKPL-387
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.