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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
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
Trial sites (41)
Facility
City
Region
Status
Investigational Site 031
Phoenix
Arizona
Recruiting
Investigational Site 014
Los Angeles
California
Recruiting
Investigational Site 002
Santa Monica
California
Recruiting
Investigational Site 039
Jacksonville
Florida
Recruiting
Investigational Site 013
Chicago
Illinois
Recruiting
Investigational Site 025
Baltimore
Maryland
Recruiting
Investigational Site 028
Rochester
Minnesota
Recruiting
Investigational Site 011
New York
New York
Recruiting
Investigational Site 003
New York
New York
Recruiting
Investigational Site 009
Cincinnati
Ohio
Recruiting
Investigational Site 040
Cleveland
Ohio
Recruiting
Investigational Site 005
Austin
Texas
Recruiting
Investigational Site 006
Houston
Texas
Recruiting
Investigational Site 004
Charlottesville
Virginia
Recruiting
Investigational Site 001
Norfolk
Virginia
Recruiting
Investigational Site 008
Richmond
Virginia
Recruiting
Investigational Site 010
Ottawa
Ontario
Recruiting
Investigational Site 027
Paris
France
Recruiting
Investigational Site 026
Poitiers
France
Recruiting
Investigational Site 032
Toulouse
France
Recruiting
Investigational Site 038
Toulouse
France
Recruiting
Investigational Site 041
Dresden
Germany
Recruiting
Investigational Site 035
Athens
Greece
Recruiting
Investigational Site 023
Nea Ionia
Greece
Recruiting
Investigational Site 024
Voula
Greece
Recruiting
Investigational Site 034
Genoa
Italy
Recruiting
Investigational Site 021
Milan
Italy
Recruiting
Investigational Site 036
Padua
Italy
Recruiting
Investigational Site 033
Udine
Italy
Recruiting
Investigational Site 037
Varese
Italy
Recruiting
Investigational Site 020
Warsaw
Poland
Recruiting
Investigational Site 030
Belgrade
Serbia
Recruiting
Investigational Site 029
Belgrade
Serbia
Recruiting
Investigational Site 019
Barcelona
Spain
Recruiting
Investigational Site 015
Barcelona
Spain
Recruiting
Investigational Site 017
Madrid
Spain
Recruiting
Investigational Site 016
Madrid
Spain
Recruiting
Investigational Site 018
Valencia
Spain
Recruiting
Investigational Site 012
London
United Kingdom
Recruiting
Investigational Site 022
London
United Kingdom
Recruiting
+ 1 more sites — see the full list on the official registry below.
More Kiniksa Pharmaceuticals International, plc trials in the UK
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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