Phase 2/3 Study of KPL-387 in Recurrent Pericarditis
Start Date
7/25/2025
Completion Date
12/31/2029
Summary
This study is being done to demonstrate whether KPL-387 is an effective and safe treatment for recurrent pericarditis.
Detailed Description
This clinical trial is comprised of 3 separate study parts: Phase 2, Phase 3, and Long-Term Extension. The primary objective of Phase 2 is to evaluate how well different dose regimens of KPL-387 control the pain and inflammation of pericarditis in a group of participants experiencing an acute episode of recurrent pericarditis. This part of the study will confirm the KPL-387 dose regimen to be further tested in Phase 3 and the Long-Term Extension. The primary objective of Phase 3 is to confirm the efficacy of KPL-387 for the treatment of recurrent pericarditis and reduction in risk of recurrence in an additional group of participants experiencing an acute episode of recurrent pericarditis. Participants who complete Phase 2 or Phase 3 may be eligible to participate in the Long-Term Extension. The primary objective of the Long-Term Extension is to assess the long-term efficacy of KPL-387 while maintaining long-term disease control. All of the study parts also have other objectives to learn about the safety, tolerability, concentration of KPL-387 in blood, and effects of KPL-387 on blood test markers of immune activity in recurrent pericarditis.
Eligibility Criteria
Age Range: 18 years to 80 years
Interventions
KPL-387
Placebo
Conditions
Locations
Investigational Site 018
Gilbert, Arizona 85297
United States
Investigational Site 053
Phoenix, Arizona 85054
United States
Investigational Site 030
Los Angeles, California 90048
United States
Investigational Site 008
San Francisco, California 94158
United States
Investigational Site 044
Santa Monica, California 90404
United States
Investigational Site 058
Ventura, California 93003
United States
Investigational Site 016
Westminster, Colorado 80023
United States
Investigational Site 001
Columbus, Georgia 31904
United States
Investigational Site 004
Chicago, Illinois 60611
United States
Investigational Site 014
Indianapolis, Indiana 46184
United States
Investigational Site 002
Overland Park, Kansas 66221
United States
Investigational Site 043
Baltimore, Maryland 21287
United States
Investigational Site 054
Boston, Massachusetts 02411
United States
Investigational Site 055
Minneapolis, Minnesota 55407
United States
Investigational Site 012
Rochester, Minnesota 55905
United States
Investigational Site 050
Kansas City, Missouri 64111
United States
Investigational Site 046
Kansas City, Missouri 66160
United States
Investigational Site 015
New York, New York 10016
United States
Investigational Site 022
New York, New York 10032
United States
Investigational Site 009
Cincinnati, Ohio 45219
United States
Investigational Site 003
Cleveland, Ohio 44195
United States
Investigational Site 005
Austin, Texas 78705
United States
Investigational Site 013
Houston, Texas 77030
United States
Investigational Site 042
Burlington, Vermont 05401
United States
Investigational Site 006
Charlottesville, Virginia 22903
United States
Investigational Site 023
Norfolk, Virginia 23507
United States
Investigational Site 045
Richmond, Virginia 23284
United States
Investigational Site 027
Ottawa, Ontario K1N 6N5
Canada
Investigational Site 028
Montpellier, 34090
France
Investigational Site 021
Paris, 75013
France
Investigational Site 036
Pessac, 33600
France
Investigational Site 019
Poitiers, 86000
France
Investigational Site 037
Toulouse, 31400
France
Investigational Site 038
Toulouse, 31400
France
Investigational Site 052
Dresden, 01069
Germany
Investigational Site 034
Athens, 115 28
Greece
Investigational Site 039
Nea Ionia, 142 33
Greece
Investigational Site 032
Voula, 166 73
Greece
Investigational Site 029
Genoa, 16132
Italy
Investigational Site 040
Genoa, 16147
Italy
Investigational Site 056
Milan, 20132
Italy
Investigational Site 007
Milan, 20157
Italy
Investigational Site 050
Padua, 35143
Italy
Investigational Site 033
Udine, 33100
Italy
Investigational Site 041
Varese, 21100
Italy
Investigational Site 051
Warsaw, 02-097
Poland
Investigational Site 031
Warsaw, 02-507
Poland
Investigational Site 025
Belgrade, 11000
Serbia
Investigational Site 026
Belgrade, 11040
Serbia
Investigational Site 048
Barcelona, 08017
Spain
Investigational Site 010
Barcelona, 8035
Spain
Investigational Site 024
Madrid, 28850
Spain
Investigational Site 011
Murcia, 30120
Spain
Investigational Site 057
Valencia, 46015
Spain
Investigational Site 020
London, EC1A 7BE
United Kingdom
Investigational Site 047
London, NW3 2QG
United Kingdom
Investigational Site 035
London, SE1 7EH
United Kingdom
Investigational Site 017
Southampton, SO17 1BJ
United Kingdom