A Phase 2/3 Efficacy and Safety Study of KPL-387 Treatment in Participants With Recurrent Pericarditis
Status: Recruiting
Location: See all (4) 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
Georgia
Investigational Site 001
RECRUITING
Columbus
Illinois
Investigational Site 004
RECRUITING
Chicago
Kansas
Investigational Site 002
RECRUITING
Overland Park
Ohio
Investigational Site 003
RECRUITING
Cleveland
Contact Information
Primary
Clinical Project Manager
clinicaltrials@kiniksa.com
781-431-9100
Time Frame
Start Date: 2025-10-31
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