NCT07288216

Brief Summary

The primary objective of this study is to characterize the efficacy and safety of dosing regimens used to transition from prior pericarditis therapies to KPL-387 monotherapy in participants with well-controlled recurrent pericarditis on standard therapies.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for phase_2

Timeline
45mo left

Started Mar 2026

Typical duration for phase_2

Geographic Reach
3 countries

12 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress3%
Mar 2026Dec 2029

First Submitted

Initial submission to the registry

December 2, 2025

Completed
15 days until next milestone

First Posted

Study publicly available on registry

December 17, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

March 25, 2026

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2029

Last Updated

April 17, 2026

Status Verified

November 1, 2025

Enrollment Period

1.8 years

First QC Date

December 2, 2025

Last Update Submit

April 16, 2026

Conditions

Recurrent PericarditisHeart DiseasesPericarditis

Keywords

RecurrenceRecurrentKPL-387Recurrent Pericarditis

Outcome Measures

Primary Outcomes (2)

  • Posology: Proportion of participants free from Pericarditis Recurrence by Week 16

    From 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

Secondary Outcomes (5)

  • Posology: Time to Pericarditis Recurrence by Week 16

    From first administration of study drug up to Week 16

  • Long Term Extension: Change from LTE Baseline in SF-36v2 Physical Component Summary score through the end of the LTE

    Up to 24 Months

  • Long Term Extension: Change from LTE Baseline in SF-36v2 Mental Component Summary score through the end of the LTE

    Up to 24 Months

  • Long Term Extension: Change from LTE Baseline in EQ-5D-5L individual index scores over time through the end of the LTE

    Up to 24 months

  • Long Term Extension: Change from LTE Baseline in EQ-5D-5L visual analog scale (VAS) over time through the end of the LTE.

    Up to 24 months

Study Arms (2)

Posology KPL-387

EXPERIMENTAL

In Posology Study, KPL-387 will be administered by subcutaneous (SC) injection through Week 16.

Drug: KPL-387

Long-Term Extension

EXPERIMENTAL

Participants from Posology Study who continue into the Long-Term Extension will receive KPL-387 for up to 24 months or until KPL-387 is approved for commercial use in that region to treat pericarditis, whichever occurs first.

Drug: KPL-387

Interventions

KPL-387DRUG

administered by subcutaneous injection

Long-Term ExtensionPosology KPL-387

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Investigational Site 002

Santa Monica, California, 90404, United States

RECRUITING

Investigational Site 011

New York, New York, 10016, United States

RECRUITING

Investigational Site 003

New York, New York, 10032, United States

RECRUITING

Investigational Site 009

Cincinnati, Ohio, 45219, United States

RECRUITING

Investigational Site 005

Austin, Texas, 78705, United States

RECRUITING

Investigational Site 006

Houston, Texas, 77030, United States

RECRUITING

Investigational Site 004

Charlottesville, Virginia, 22903, United States

RECRUITING

Investigational Site 001

Norfolk, Virginia, 23507, United States

RECRUITING

Investigational Site 008

Richmond, Virginia, 23284, United States

RECRUITING

Investigational Site 010

Ottawa, Ontario, K1N 6N5, Canada

RECRUITING

Investigational Site 012

London, EC1A 7BE, United Kingdom

RECRUITING

Investigational Site 007

London, SE1 7EH, United Kingdom

RECRUITING

MeSH Terms

Conditions

PericarditisHeart DiseasesRecurrence

Condition Hierarchy (Ancestors)

Cardiovascular DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Clinical Project Manager

CONTACT

781-431-9100clinicaltrials@kiniksa.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 2, 2025

First Posted

December 17, 2025

Study Start

March 25, 2026

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2029

Last Updated

April 17, 2026

Record last verified: 2025-11

Locations

US(9)CA(1)GB(2)