Actively Recruiting
A Phase 2 Study Evaluating Transition to KPL-387 Monotherapy with Long-Term Extension in Well-Controlled Recurrent Pericarditis
Led by Kiniksa Pharmaceuticals International, plc · Updated on 2026-06-08
80
Participants Needed
32
Research Sites
104 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
This research aims to assess the effectiveness and safety of different dosing plans for switching patients with well-controlled recurrent pericarditis from their current treatments to KPL-387 alone. The study focuses on participants who have stable recurrent pericarditis while on standard therapies, including NSAIDs, colchicine, glucocorticoids, or IL-1 pathway inhibitors. Researchers seek to understand how best to transition patients to KPL-387 monotherapy. Participants will receive KPL-387 through subcutaneous injections for up to 16 weeks during the Posology Study phase. Those who complete this phase and have not finished the End of Treatment visit may continue into a Long-Term Extension (LTE) phase, receiving KPL-387 for up to 24 months or until the drug is approved for commercial use in their region. During both phases, KPL-387 dosing follows specific protocol guidelines, and participants are monitored closely. Throughout the study, participants will have regular visits where they report chest pain symptoms using a pericarditis pain rating scale and undergo physical examinations and laboratory tests, including C-reactive protein levels. Researchers will also assess treatment tolerability and drug levels in the body. The main outcomes include the rate of pericarditis recurrence by week 16 and during the LTE, along with quality of life measures. Participants who do not continue in the LTE will have safety follow-up visits up to eight weeks after their last dose.
CONDITIONS
Brief 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
- Well-controlled recurrent pericarditis with CRP less than 0.5 mg/dL within 14 days of baseline
- Pericarditis pain numerical rating score of 3 or less at baseline
- Documented history of CRP elevation above 1 mg/dL linked to at least one prior acute pericarditis episode
- Treated for recurrent pericarditis with standard therapies or IL-1 inhibitors for at least 3 months
- Currently on a stable dose regimen of NSAIDs, colchicine, glucocorticoids, or IL-1 pathway inhibitors
You will not qualify if you...
- Diagnosis of pericarditis due to specific prohibited causes
- Pericarditis recurrence within 3 months before baseline
- Use or planned use of investigational drugs within 4 weeks prior to or during the study
- History of active or untreated latent tuberculosis
- History of immunodeficiency or immunosuppression, including positive HIV test
- Chest X-ray showing malignancy, prior or active tuberculosis, or active infection
- History of malignancy within 5 years, excluding certain skin or cervical cancers
- Current active infection or history of recurrent infections (more than 3 episodes in past year)
- Serious infection requiring hospitalization or antibiotics within 2 weeks prior to study drug
- History of organ transplant except corneal transplant over 3 months prior
- Any other medical condition that may affect participation or study evaluations
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
screening and enrollment visit
Duration - Up to 16 weeks
Participants transition to and receive KPL-387 by subcutaneous injection according to protocol guidelines during the Posology Study. They will be monitored for symptoms, physical signs, laboratory evidence of pericarditis activity, treatment tolerability, and pharmacokinetics.
Multiple visits throughout the 16 weeks for assessments
Duration - Up to 24 months
Participants who continue into the Long-Term Extension will receive KPL-387 for up to 24 months or until the drug is approved for commercial use in their region. They will be regularly assessed for symptoms, physical signs, laboratory markers of pericarditis, treatment tolerability, and pharmacokinetics.
Regular visits throughout the long-term extension period
Duration - 8 weeks after last dose
Participants who do not enter the Long-Term Extension will complete an End of Treatment visit followed by safety follow-up monitoring for 8 weeks after the last dose of KPL-387 to assess safety and tolerability.
Follow-up visits for safety monitoring
Trial Site Locations
Total: 32 locations
1
Investigational Site 031
Phoenix, Arizona, United States, 85054
Actively Recruiting
2
Investigational Site 014
Los Angeles, California, United States, 90048
Actively Recruiting
3
Investigational Site 002
Santa Monica, California, United States, 90404
Actively Recruiting
4
Investigational Site 013
Chicago, Illinois, United States, 60611
Actively Recruiting
5
Investigational Site 025
Baltimore, Maryland, United States, 21287
Actively Recruiting
6
Investigational Site 028
Rochester, Minnesota, United States, 55905
Actively Recruiting
7
Investigational Site 011
New York, New York, United States, 10016
Actively Recruiting
8
Investigational Site 003
New York, New York, United States, 10032
Actively Recruiting
9
Investigational Site 009
Cincinnati, Ohio, United States, 45219
Actively Recruiting
10
Investigational Site 005
Austin, Texas, United States, 78705
Actively Recruiting
11
Investigational Site 006
Houston, Texas, United States, 77030
Actively Recruiting
12
Investigational Site 004
Charlottesville, Virginia, United States, 22903
Actively Recruiting
13
Investigational Site 001
Norfolk, Virginia, United States, 23507
Actively Recruiting
14
Investigational Site 008
Richmond, Virginia, United States, 23284
Actively Recruiting
15
Investigational Site 010
Ottawa, Ontario, Canada, K1N 6N5
Actively Recruiting
16
Investigational Site 027
Paris, France, 75013
Actively Recruiting
17
Investigational Site 026
Poitiers, France, 86000
Actively Recruiting
18
Investigational Site 032
Toulouse, France, 31400
Actively Recruiting
19
Investigational Site 023
Nea Ionia, Greece, 142 33
Actively Recruiting
20
Investigational Site 024
Voula, Greece, 166 73
Actively Recruiting
21
Investigational Site 021
Milan, Italy, 20157
Actively Recruiting
22
Investigational Site 020
Warsaw, Poland, 02-507
Actively Recruiting
23
Investigational Site 030
Belgrade, Serbia, 1100
Actively Recruiting
24
Investigational Site 029
Belgrade, Serbia, 11040
Actively Recruiting
25
Investigational Site 019
Barcelona, Spain, 08017
Actively Recruiting
26
Investigational Site 015
Barcelona, Spain, 08035
Actively Recruiting
27
Investigational Site 017
Madrid, Spain, 28034
Actively Recruiting
28
Investigational Site 016
Madrid, Spain, 28850
Actively Recruiting
29
Investigational Site 018
Valencia, Spain, 46015
Actively Recruiting
30
Investigational Site 012
London, United Kingdom, EC1A 7BE
Actively Recruiting
31
Investigational Site 022
London, United Kingdom, NW3 2QG
Actively Recruiting
32
Investigational Site 007
London, United Kingdom, SE1 7EH
Actively Recruiting
Research Team
C
Clinical Project Manager
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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