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NCT07010159PHASE2, PHASE3Recruiting

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

Kiniksa Pharmaceuticals International, plc

Start Date

7/25/2025

Completion Date

12/31/2029

Summary

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

Detailed Description

This clinical trial is comprised of 3 separate study parts: Phase 2, Phase 3, and Long-Term Extension. The primary objective of Phase 2 is to evaluate how well different dose regimens of KPL-387 control the pain and inflammation of pericarditis in a group of participants experiencing an acute episode of recurrent pericarditis. This part of the study will confirm the KPL-387 dose regimen to be further tested in Phase 3 and the Long-Term Extension. The primary objective of Phase 3 is to confirm the efficacy of KPL-387 for the treatment of recurrent pericarditis and reduction in risk of recurrence in an additional group of participants experiencing an acute episode of recurrent pericarditis. Participants who complete Phase 2 or Phase 3 may be eligible to participate in the Long-Term Extension. The primary objective of the Long-Term Extension is to assess the long-term efficacy of KPL-387 while maintaining long-term disease control. All of the study parts also have other objectives to learn about the safety, tolerability, concentration of KPL-387 in blood, and effects of KPL-387 on blood test markers of immune activity in recurrent pericarditis.

Eligibility Criteria

Age Range: 18 years to 80 years

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.

Interventions

DRUG

KPL-387

DRUG

Placebo

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Conditions

PericarditisPericarditis AcuteRecurrent Pericarditis

Locations

Investigational Site 018

Gilbert, Arizona 85297

United States

Investigational Site 053

Phoenix, Arizona 85054

United States

Investigational Site 030

Los Angeles, California 90048

United States

Investigational Site 008

San Francisco, California 94158

United States

Investigational Site 044

Santa Monica, California 90404

United States

Investigational Site 058

Ventura, California 93003

United States

Investigational Site 016

Westminster, Colorado 80023

United States

Investigational Site 001

Columbus, Georgia 31904

United States

Investigational Site 004

Chicago, Illinois 60611

United States

Investigational Site 014

Indianapolis, Indiana 46184

United States

Investigational Site 002

Overland Park, Kansas 66221

United States

Investigational Site 043

Baltimore, Maryland 21287

United States

Investigational Site 054

Boston, Massachusetts 02411

United States

Investigational Site 055

Minneapolis, Minnesota 55407

United States

Investigational Site 012

Rochester, Minnesota 55905

United States

Investigational Site 050

Kansas City, Missouri 64111

United States

Investigational Site 046

Kansas City, Missouri 66160

United States

Investigational Site 015

New York, New York 10016

United States

Investigational Site 022

New York, New York 10032

United States

Investigational Site 009

Cincinnati, Ohio 45219

United States

Investigational Site 003

Cleveland, Ohio 44195

United States

Investigational Site 005

Austin, Texas 78705

United States

Investigational Site 013

Houston, Texas 77030

United States

Investigational Site 042

Burlington, Vermont 05401

United States

Investigational Site 006

Charlottesville, Virginia 22903

United States

Investigational Site 023

Norfolk, Virginia 23507

United States

Investigational Site 045

Richmond, Virginia 23284

United States

Investigational Site 027

Ottawa, Ontario K1N 6N5

Canada

Investigational Site 028

Montpellier, 34090

France

Investigational Site 021

Paris, 75013

France

Investigational Site 036

Pessac, 33600

France

Investigational Site 019

Poitiers, 86000

France

Investigational Site 037

Toulouse, 31400

France

Investigational Site 038

Toulouse, 31400

France

Investigational Site 052

Dresden, 01069

Germany

Investigational Site 034

Athens, 115 28

Greece

Investigational Site 039

Nea Ionia, 142 33

Greece

Investigational Site 032

Voula, 166 73

Greece

Investigational Site 029

Genoa, 16132

Italy

Investigational Site 040

Genoa, 16147

Italy

Investigational Site 056

Milan, 20132

Italy

Investigational Site 007

Milan, 20157

Italy

Investigational Site 050

Padua, 35143

Italy

Investigational Site 033

Udine, 33100

Italy

Investigational Site 041

Varese, 21100

Italy

Investigational Site 051

Warsaw, 02-097

Poland

Investigational Site 031

Warsaw, 02-507

Poland

Investigational Site 025

Belgrade, 11000

Serbia

Investigational Site 026

Belgrade, 11040

Serbia

Investigational Site 048

Barcelona, 08017

Spain

Investigational Site 010

Barcelona, 8035

Spain

Investigational Site 024

Madrid, 28850

Spain

Investigational Site 011

Murcia, 30120

Spain

Investigational Site 057

Valencia, 46015

Spain

Investigational Site 020

London, EC1A 7BE

United Kingdom

Investigational Site 047

London, NW3 2QG

United Kingdom

Investigational Site 035

London, SE1 7EH

United Kingdom

Investigational Site 017

Southampton, SO17 1BJ

United Kingdom