NCT07010159

Phase 2/3 Study of KPL-387 in Recurrent Pericarditis

A Phase 2/3 Efficacy and Safety Study of KPL-387 Treatment in Participants With Recurrent Pericarditis

• Status: Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 165 (estimated)
• Sponsor: Kiniksa Pharmaceuticals International, plc · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pericarditis
• Pericarditis Acute
• Recurrent Pericarditis

Interventions

Type	Name	Description
DRUG	KPL-387	administered by subcutaneous injection
DRUG	Placebo	administered by subcutaneous injection

Timeline

• Start date: 2025-07-25
• Primary completion: 2027-12-31
• Completion: 2029-12-31
• First posted: 2025-06-08
• Last updated: 2026-04-17

Locations

50 sites across 9 countries: United States, Canada, France, Greece, Italy, Poland, Serbia, Spain, United Kingdom

Regulatory

• FDA-regulated drug study