Actively Recruiting
Transition to KPL-387 Monotherapy Dosing & Administration Study
Led by Kiniksa Pharmaceuticals International, plc · Updated on 2026-05-13
80
Participants Needed
14
Research Sites
196 weeks
Total Duration
On this page
Sponsors
K
Kiniksa Pharmaceuticals International, plc
Lead Sponsor
K
Kiniksa Pharmaceuticals, GmbH
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Transition to KPL-387 Monotherapy Dosing & Administration Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 80 years
- Diagnosed with well-controlled recurrent pericarditis, including C-reactive protein less than 0.5 mg/dL within 14 days before baseline and pericarditis pain score 3 or less at baseline
- Documented history of elevated C-reactive protein above 1 mg/dL linked to at least one acute pericarditis episode
- Received treatment for recurrent pericarditis for at least 3 months before baseline with stable doses of NSAIDs, colchicine, glucocorticoids, or interleukin-1 pathway inhibitors (anakinra or rilonacept)
You will not qualify if you...
- Pericarditis due to specific excluded causes
- Pericarditis recurrence within 3 months before baseline
- Use of investigational drugs within 4 weeks before study drug or planned investigational drug use during the study
- History of active or untreated latent tuberculosis before screening
- History of immunodeficiency or immunosuppression, including HIV positive status
- Chest X-ray within 12 weeks before study drug showing malignancy, signs of tuberculosis, or active infection
- History of malignancy within 5 years before screening except certain treated skin or cervical cancers
- Known or suspected active infection or history of frequent infections (more than 3 episodes in past year), including genitourinary, chest, sinus, or skin infections
- Serious infection requiring hospitalization or antibiotic treatment within 2 weeks before study drug
- History of organ transplant except corneal transplant done more than 3 months before study drug
- Any other medical condition that may affect participation or study assessments as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 14 locations
1
Investigational Site 014
Los Angeles, California, United States, 90048
Actively Recruiting
2
Investigational Site 002
Santa Monica, California, United States, 90404
Actively Recruiting
3
Investigational Site 013
Chicago, Illinois, United States, 60611
Actively Recruiting
4
Investigational Site 011
New York, New York, United States, 10016
Actively Recruiting
5
Investigational Site 003
New York, New York, United States, 10032
Actively Recruiting
6
Investigational Site 009
Cincinnati, Ohio, United States, 45219
Actively Recruiting
7
Investigational Site 005
Austin, Texas, United States, 78705
Actively Recruiting
8
Investigational Site 006
Houston, Texas, United States, 77030
Actively Recruiting
9
Investigational Site 004
Charlottesville, Virginia, United States, 22903
Actively Recruiting
10
Investigational Site 001
Norfolk, Virginia, United States, 23507
Actively Recruiting
11
Investigational Site 008
Richmond, Virginia, United States, 23284
Actively Recruiting
12
Investigational Site 010
Ottawa, Ontario, Canada, K1N 6N5
Actively Recruiting
13
Investigational Site 012
London, United Kingdom, EC1A 7BE
Actively Recruiting
14
Investigational Site 007
London, United Kingdom, SE1 7EH
Actively Recruiting
Research Team
C
Clinical Project Manager
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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