Recruiting

Phase 2

KPL-387Transition to KPL-387 Monotherapy Dosing & Administration Study

Sponsor:

Kiniksa Pharmaceuticals International, plc

Code:

NCT07288216

Conditions

Recurrent Pericarditis

Heart Diseases

Pericarditis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

KPL-387

Study Details

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.

Conditions

Recurrent Pericarditis

Heart Diseases

Pericarditis

Study ID

NCT07288216

Start date

Mar 25, 2026

Status verified date

Jun, 2026

Completion date

Dec 31, 2029

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Key Inclusion Criteria:

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).

Key Exclusion Criteria:

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.

Study Design

Enrollment

80 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Posology KPL-387

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

experimental: Long-Term Extension

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.

Interventions

KPL-387

administered by subcutaneous injection

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Clinical Project Manager

781-431-9100 clinicaltrials@kiniksa.com

Locations

Investigational Site 031

Recruiting

Phoenix, Arizona, United States, 85054

Investigational Site 014

Recruiting

Los Angeles, California, United States, 90048

Investigational Site 002

Recruiting

Santa Monica, California, United States, 90404

Investigational Site 039

Recruiting

Jacksonville, Florida, United States, 32224

Investigational Site 013

Recruiting

Chicago, Illinois, United States, 60611

Investigational Site 025

Recruiting

Baltimore, Maryland, United States, 21287

Investigational Site 028

Recruiting

Rochester, Minnesota, United States, 55905

Investigational Site 011

Recruiting

New York, New York, United States, 10016

Investigational Site 003

Recruiting

New York, New York, United States, 10032

Investigational Site 009

Recruiting

Cincinnati, Ohio, United States, 45219

Investigational Site 040

Recruiting

Cleveland, Ohio, United States, 44195

Investigational Site 005

Recruiting

Austin, Texas, United States, 78705

Investigational Site 006

Recruiting

Houston, Texas, United States, 77030

Investigational Site 004

Recruiting

Charlottesville, Virginia, United States, 22903

Investigational Site 001

Recruiting

Norfolk, Virginia, United States, 23507

Investigational Site 008

Recruiting

Richmond, Virginia, United States, 23284

Investigational Site 010

Recruiting

Ottawa, Ontario, Canada, K1N 6N5

More Information

Sponsor

Kiniksa Pharmaceuticals International, plc

Last update posted

Aug 11, 2026

Last verified

Jun, 2026

Keywords

Recurrence
Recurrent
KPL-387
Recurrent Pericarditis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Kiniksa Pharmaceuticals International, plc on 2026-08-11.