A Phase 2/3 Efficacy and Safety Study of KPL-387 Treatment in Participants With Recurrent Pericarditis
Status: Recruiting
Location: See all (46) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
SUMMARY
This study is being done to demonstrate whether KPL-387 is an effective and safe treatment for recurrent pericarditis.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:
• Phase 2 and 3: Has a diagnosis of recurrent pericarditis
• Phase 2 and 3: Has signs and symptoms of recurrent pericarditis despite treatment with standard therapies
• Phase 2 and 3: Weighs at least 40 kg
• Phase 2: Taking NSAIDS and/or colchicine (in any combination)
• Phase 3: Taking NSAIDs and/or colchicine and/or glucocorticoids (in any combination)
Locations
United States
Arizona
Investigational Site 018
RECRUITING
Gilbert
California
Investigational Site 030
RECRUITING
Los Angeles
Investigational Site 008
RECRUITING
San Francisco
Investigational Site 044
RECRUITING
Santa Monica
Colorado
Investigational Site 016
RECRUITING
Westminster
Georgia
Investigational Site 001
RECRUITING
Columbus
Illinois
Investigational Site 004
RECRUITING
Chicago
Indiana
Investigational Site 014
RECRUITING
Indianapolis
Kansas
Investigational Site 002
RECRUITING
Overland Park
Maryland
Investigational Site 043
RECRUITING
Baltimore
Minnesota
Investigational Site 012
RECRUITING
Rochester
Missouri
Investigational Site 046
RECRUITING
Kansas City
New York
Investigational Site 015
RECRUITING
New York
Investigational Site 022
RECRUITING
New York
Ohio
Investigational Site 009
RECRUITING
Cincinnati
Investigational Site 003
RECRUITING
Cleveland
Texas
Investigational Site 005
RECRUITING
Austin
Investigational Site 013
RECRUITING
Houston
Virginia
Investigational Site 006
RECRUITING
Charlottesville
Investigational Site 023
RECRUITING
Norfolk
Investigational Site 045
RECRUITING
Richmond
Vermont
Investigational Site 042
RECRUITING
Burlington
Other Locations
Canada
Investigational Site 027
RECRUITING
Ottawa
France
Investigational Site 028
RECRUITING
Montpellier
Investigational Site 021
RECRUITING
Paris
Investigational Site 036
RECRUITING
Pessac
Investigational Site 019
RECRUITING
Poitiers
Investigational Site 037
RECRUITING
Toulouse
Investigational Site 038
RECRUITING
Toulouse
Greece
Investigational Site 034
RECRUITING
Athens
Investigational Site 039
RECRUITING
Nea Ionia
Investigational Site 032
RECRUITING
Voula
Italy
Investigational Site 029
RECRUITING
Genoa
Investigational Site 040
RECRUITING
Genoa
Investigational Site 007
RECRUITING
Milan
Investigational Site 033
RECRUITING
Udine
Investigational Site 041
RECRUITING
Varese
Poland
Investigational Site 031
RECRUITING
Warsaw
Serbia
Investigational Site 025
RECRUITING
Belgrade
Investigational Site 026
RECRUITING
Belgrade
Spain
Investigational Site 010
RECRUITING
Barcelona
Investigational Site 024
RECRUITING
Madrid
Investigational Site 011
RECRUITING
Murcia
United Kingdom
Investigational Site 020
RECRUITING
London
Investigational Site 035
RECRUITING
London
Investigational Site 017
RECRUITING
Southampton
Contact Information
Primary
Clinical Project Manager
clinicaltrials@kiniksa.com
781-431-9100
Time Frame
Start Date: 2025-07-25
Estimated Completion Date: 2029-12-31
Participants
Target number of participants: 165
Treatments
Experimental: Phase 2 KPL-387 100mg SC q2wk
In Phase 2 Treatment Period KPL-387 will be administered by subcutaneous (SC) injection every 2 weeks (q2wk) through Week 22.
Experimental: Phase 2 KPL-387 100mg SC q4wk
In Phase 2 Treatment Period, KPL-387 or placebo (alternating every 2 weeks) will be administered by SC injection q2wk through Week 22 to provide active drug administration every 4 weeks (q4wk) while maintaining treatment concealment.
Experimental: Phase 2 KPL-387 300mg SC q2wk
In Phase 2 Treatment Period KPL-387 will be administered by SC injection q2wk through Week 22.
Experimental: Phase 2 KPL-387 300mg SC q4wk
In Phase 2 Treatment Period, KPL-387 or placebo (alternating every 2 weeks) will be administered by SC injection q2wk through Week 22 to provide active drug administration q4wk while maintaining treatment concealment.
Experimental: Phase 3 KPL-387 SC
Run-In (RI) Period: participants receive single-blind KPL-387~Randomized Withdrawal (RW) Period: eligible participants are randomized (1:1 KPL-387 or placebo) to receive double-blinded KPL-387.
Placebo_comparator: Phase 3 Placebo SC
RW Period: eligible participants are randomized (1:1 KPL-387 or placebo) to receive double-blinded placebo.
Experimental: Long-Term Extension
Participants from Phase 2 and Phase 3 who continue into the Long-Term Extension will receive KPL-387.
Related Therapeutic Areas
Sponsors
Collaborators: Kiniksa Pharmaceuticals, GmbH
Leads: Kiniksa Pharmaceuticals International, plc