Actively Recruiting
A Phase 2/3 Study of KPL-387 Treatment in Participants With Recurrent Pericarditis Evaluating Efficacy and Safety
Led by Kiniksa Pharmaceuticals International, plc · Updated on 2026-06-08
165
Participants Needed
58
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
Researchers are studying KPL-387 to see if it can safely and effectively treat recurrent pericarditis, a condition where inflammation and pain return in the sac surrounding the heart. This clinical trial has three parts: Phase 2 to find the best dose, Phase 3 to confirm how well it works, and a Long-Term Extension to monitor ongoing disease control. The study also looks at safety, how the drug behaves in the body, and its effect on blood markers linked to immune activity. Participants in Phase 2 receive KPL-387 by subcutaneous injection every two weeks or alternating with placebo to maintain blinding, continuing through Week 22. Phase 3 includes a Run-In Period with KPL-387 followed by a randomized withdrawal period where participants receive either KPL-387 or placebo without knowing which. Those who finish Phase 2 or Phase 3 may join the Long-Term Extension, where all receive KPL-387 to assess long-term outcomes. During the study, participants will have regular visits for evaluations including pain and inflammation assessments, blood tests measuring inflammation markers like CRP, and heart function tests such as echocardiograms and electrocardiograms. Researchers will track time to treatment response, recurrence of pericarditis, and changes in quality of life through questionnaires. The study follows participants up to two years in the extension phase to monitor disease control and safety.
CONDITIONS
Brief Title
Phase 2/3 Study of KPL-387 in Recurrent Pericarditis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of recurrent pericarditis
- Signs and symptoms of recurrent pericarditis despite standard therapies
- Weighs at least 40 kg
- For Phase 2: Taking NSAIDs and/or colchicine
- For Phase 3: Taking NSAIDs and/or colchicine and/or glucocorticoids
You will not qualify if you...
- Pericarditis caused by specific prohibited conditions
- Received investigational drugs within 4 weeks before screening or plans to during 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 TB, or active infection
- History of malignancy within past 5 years except certain skin or cervical cancers
- Current active infection or frequent/recurrent infections
- Recent serious infection needing hospitalization or antibiotics
- History of organ transplant other than certain corneal transplants
- Any other medical condition that may affect participation or study evaluations
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to the start of the Randomized Withdrawal Period
Participants receive single-blind KPL-387 treatment to assess initial response.
1 baseline visit and multiple visits during run-in
Duration - Up to 22 weeks in Phase 2; variable in Phase 3 depending on period
Participants receive KPL-387 or placebo by subcutaneous injection during Phase 2 and Phase 3 to control pain and inflammation of recurrent pericarditis.
Weekly or biweekly visits for up to 22 weeks in Phase 2; visits during randomized withdrawal period in Phase 3
Duration - Up to 24 months
Participants from Phase 2 and Phase 3 who continue into the Long-Term Extension receive KPL-387 to assess long-term efficacy and disease control.
Regular visits throughout extension period
Trial Site Locations
Total: 58 locations
1
Investigational Site 018
Gilbert, Arizona, United States, 85297
Actively Recruiting
2
Investigational Site 053
Phoenix, Arizona, United States, 85054
Actively Recruiting
3
Investigational Site 030
Los Angeles, California, United States, 90048
Actively Recruiting
4
Investigational Site 008
San Francisco, California, United States, 94158
Actively Recruiting
5
Investigational Site 044
Santa Monica, California, United States, 90404
Actively Recruiting
6
Investigational Site 058
Ventura, California, United States, 93003
Actively Recruiting
7
Investigational Site 016
Westminster, Colorado, United States, 80023
Actively Recruiting
8
Investigational Site 001
Columbus, Georgia, United States, 31904
Withdrawn
9
Investigational Site 004
Chicago, Illinois, United States, 60611
Actively Recruiting
10
Investigational Site 014
Indianapolis, Indiana, United States, 46184
Actively Recruiting
11
Investigational Site 002
Overland Park, Kansas, United States, 66221
Withdrawn
12
Investigational Site 043
Baltimore, Maryland, United States, 21287
Actively Recruiting
13
Investigational Site 054
Boston, Massachusetts, United States, 02411
Actively Recruiting
14
Investigational Site 055
Minneapolis, Minnesota, United States, 55407
Actively Recruiting
15
Investigational Site 012
Rochester, Minnesota, United States, 55905
Actively Recruiting
16
Investigational Site 050
Kansas City, Missouri, United States, 64111
Actively Recruiting
17
Investigational Site 046
Kansas City, Missouri, United States, 66160
Actively Recruiting
18
Investigational Site 015
New York, New York, United States, 10016
Actively Recruiting
19
Investigational Site 022
New York, New York, United States, 10032
Actively Recruiting
20
Investigational Site 009
Cincinnati, Ohio, United States, 45219
Actively Recruiting
21
Investigational Site 003
Cleveland, Ohio, United States, 44195
Actively Recruiting
22
Investigational Site 005
Austin, Texas, United States, 78705
Actively Recruiting
23
Investigational Site 013
Houston, Texas, United States, 77030
Actively Recruiting
24
Investigational Site 042
Burlington, Vermont, United States, 05401
Actively Recruiting
25
Investigational Site 006
Charlottesville, Virginia, United States, 22903
Actively Recruiting
26
Investigational Site 023
Norfolk, Virginia, United States, 23507
Actively Recruiting
27
Investigational Site 045
Richmond, Virginia, United States, 23284
Actively Recruiting
28
Investigational Site 027
Ottawa, Ontario, Canada, K1N 6N5
Actively Recruiting
29
Investigational Site 028
Montpellier, France, 34090
Actively Recruiting
30
Investigational Site 021
Paris, France, 75013
Actively Recruiting
31
Investigational Site 036
Pessac, France, 33600
Actively Recruiting
32
Investigational Site 019
Poitiers, France, 86000
Actively Recruiting
33
Investigational Site 037
Toulouse, France, 31400
Actively Recruiting
34
Investigational Site 038
Toulouse, France, 31400
Actively Recruiting
35
Investigational Site 052
Dresden, Germany, 01069
Actively Recruiting
36
Investigational Site 034
Athens, Greece, 115 28
Actively Recruiting
37
Investigational Site 039
Nea Ionia, Greece, 142 33
Actively Recruiting
38
Investigational Site 032
Voula, Greece, 166 73
Actively Recruiting
39
Investigational Site 029
Genoa, Italy, 16132
Actively Recruiting
40
Investigational Site 040
Genoa, Italy, 16147
Actively Recruiting
41
Investigational Site 056
Milan, Italy, 20132
Actively Recruiting
42
Investigational Site 007
Milan, Italy, 20157
Actively Recruiting
43
Investigational Site 050
Padua, Italy, 35143
Actively Recruiting
44
Investigational Site 033
Udine, Italy, 33100
Actively Recruiting
45
Investigational Site 041
Varese, Italy, 21100
Actively Recruiting
46
Investigational Site 051
Warsaw, Poland, 02-097
Actively Recruiting
47
Investigational Site 031
Warsaw, Poland, 02-507
Actively Recruiting
48
Investigational Site 025
Belgrade, Serbia, 11000
Actively Recruiting
49
Investigational Site 026
Belgrade, Serbia, 11040
Actively Recruiting
50
Investigational Site 048
Barcelona, Spain, 08017
Actively Recruiting
51
Investigational Site 010
Barcelona, Spain, 8035
Actively Recruiting
52
Investigational Site 024
Madrid, Spain, 28850
Actively Recruiting
53
Investigational Site 011
Murcia, Spain, 30120
Actively Recruiting
54
Investigational Site 057
Valencia, Spain, 46015
Actively Recruiting
55
Investigational Site 020
London, United Kingdom, EC1A 7BE
Actively Recruiting
56
Investigational Site 047
London, United Kingdom, NW3 2QG
Actively Recruiting
57
Investigational Site 035
London, United Kingdom, SE1 7EH
Actively Recruiting
58
Investigational Site 017
Southampton, United Kingdom, SO17 1BJ
Actively Recruiting
Research Team
C
Clinical Project Manager
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
7
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