A Phase 2 Posology Study With Long-Term Extension in Participants With Well-Controlled Recurrent Pericarditis to Evaluate the Efficacy and Safety of Transition Regimens to KPL-387 Monotherapy From Standard Therapies
Status: Recruiting
Location: See all (41) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:
• Has well-controlled recurrent pericarditis (i.e., including having CRP \< 0.5 mg/dL within 14 days of Baseline and a pericarditis pain NRS score ≤ 3 at Baseline)
• Has a documented history of CRP elevation (\> 1 mg/dL) associated with at least one prior acute pericarditis episode, whether the incident event or any pericarditis recurrence
• Has received treatment for RP for at least 3 months prior to Baseline with standard therapy(ies) and is currently on a stable dosing regimen including NSAIDs and/or colchicine, and/or glucocorticoids or an IL-1 pathway inhibitor (anakinra or rilonacept).
Locations
United States
Arizona
Investigational Site 031
RECRUITING
Phoenix
California
Investigational Site 014
RECRUITING
Los Angeles
Investigational Site 002
RECRUITING
Santa Monica
Florida
Investigational Site 039
RECRUITING
Jacksonville
Illinois
Investigational Site 013
RECRUITING
Chicago
Maryland
Investigational Site 025
RECRUITING
Baltimore
Minnesota
Investigational Site 028
RECRUITING
Rochester
New York
Investigational Site 003
RECRUITING
New York
Investigational Site 011
RECRUITING
New York
Ohio
Investigational Site 009
RECRUITING
Cincinnati
Investigational Site 040
RECRUITING
Cleveland
Texas
Investigational Site 005
RECRUITING
Austin
Investigational Site 006
RECRUITING
Houston
Virginia
Investigational Site 004
RECRUITING
Charlottesville
Investigational Site 001
RECRUITING
Norfolk
Investigational Site 008
RECRUITING
Richmond
Other Locations
Canada
Investigational Site 010
RECRUITING
Ottawa
France
Investigational Site 027
RECRUITING
Paris
Investigational Site 026
RECRUITING
Poitiers
Investigational Site 032
RECRUITING
Toulouse
Investigational Site 038
RECRUITING
Toulouse
Germany
Investigational Site 041
RECRUITING
Dresden
Greece
Investigational Site 035
RECRUITING
Athens
Investigational Site 023
RECRUITING
Nea Ionia
Investigational Site 024
RECRUITING
Voula
Italy
Investigational Site 034
RECRUITING
Genoa
Investigational Site 021
RECRUITING
Milan
Investigational Site 036
RECRUITING
Padua
Investigational Site 033
RECRUITING
Udine
Investigational Site 037
RECRUITING
Varese
Poland
Investigational Site 020
RECRUITING
Warsaw
Serbia
Investigational Site 029
RECRUITING
Belgrade
Investigational Site 030
RECRUITING
Belgrade
Spain
Investigational Site 015
RECRUITING
Barcelona
Investigational Site 019
RECRUITING
Barcelona
Investigational Site 016
RECRUITING
Madrid
Investigational Site 017
RECRUITING
Madrid
Investigational Site 018
RECRUITING
Valencia
United Kingdom
Investigational Site 007
RECRUITING
London
Investigational Site 012
RECRUITING
London
Investigational Site 022
RECRUITING
London
Contact Information
Primary
Clinical Project Manager
clinicaltrials@kiniksa.com
781-431-9100
Time Frame
Start Date:2026-03-25
Estimated Completion Date:2029-12-31
Participants
Target number of participants:80
Treatments
Experimental: Posology KPL-387
In Posology Study, KPL-387 will be administered by subcutaneous (SC) injection through Week 16.
Experimental: Long-Term Extension
Participants from Posology Study who continue into the Long-Term Extension will receive KPL-387 for up to 24 months or until KPL-387 is approved for commercial use in that region to treat pericarditis, whichever occurs first.