This study is being done to demonstrate whether KPL-387 is an effective and safe treatment for recurrent pericarditis.
Eligibility
Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Phase 2: Time to Treatment Response by Week 24 — From Baseline up to Week 24
Phase 3: Time to Pericarditis Recurrence — From Baseline in the RW Period
Long-Term Extension: Annualized rate of Pericarditis Recurrence — Up to 24 Months
Trial sites (63)
Facility
City
Region
Status
Investigational Site 018
Gilbert
Arizona
Recruiting
Investigational Site 053
Phoenix
Arizona
Recruiting
Investigational Site 030
Los Angeles
California
Recruiting
Investigational Site 008
San Francisco
California
Recruiting
Investigational Site 044
Santa Monica
California
Recruiting
Investigational Site 058
Ventura
California
Recruiting
Investigational Site 016
Westminster
Colorado
Recruiting
Investigational Site 061
Washington D.C.
District of Columbia
Recruiting
Investigational Site 001
Columbus
Georgia
Withdrawn
Investigational Site 004
Chicago
Illinois
Recruiting
Investigational Site 014
Indianapolis
Indiana
Recruiting
Investigational Site 002
Overland Park
Kansas
Withdrawn
Investigational Site 043
Baltimore
Maryland
Recruiting
Investigational Site 054
Boston
Massachusetts
Recruiting
Investigational Site 055
Minneapolis
Minnesota
Recruiting
Investigational Site 012
Rochester
Minnesota
Recruiting
Investigational Site 050
Kansas City
Missouri
Recruiting
Investigational Site 046
Kansas City
Missouri
Recruiting
Investigational Site 062
St Louis
Missouri
Recruiting
Investigational Site 015
New York
New York
Recruiting
Investigational Site 022
New York
New York
Recruiting
Investigational Site 009
Cincinnati
Ohio
Recruiting
Investigational Site 003
Cleveland
Ohio
Recruiting
Investigational Site 005
Austin
Texas
Recruiting
Investigational Site 013
Houston
Texas
Recruiting
Investigational Site 042
Burlington
Vermont
Recruiting
Investigational Site 006
Charlottesville
Virginia
Recruiting
Investigational Site 023
Norfolk
Virginia
Recruiting
Investigational Site 045
Richmond
Virginia
Recruiting
Investigational Site 027
Ottawa
Ontario
Recruiting
Investigational Site 028
Montpellier
France
Recruiting
Investigational Site 021
Paris
France
Recruiting
Investigational Site 036
Pessac
France
Recruiting
Investigational Site 019
Poitiers
France
Recruiting
Investigational Site 037
Toulouse
France
Recruiting
Investigational Site 038
Toulouse
France
Recruiting
Investigational Site 052
Dresden
Germany
Recruiting
Investigational Site 034
Athens
Greece
Recruiting
Investigational Site 039
Nea Ionia
Greece
Recruiting
Investigational Site 032
Voula
Greece
Recruiting
+ 23 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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