Study of Switching to KPL-387 Injection for Well-Controlled Recurrent Pericarditis with Long-Term Follow-Up

What this Trial Is About

Researchers are evaluating the effectiveness and safety of switching from current pericarditis treatments to KPL-387 monotherapy in adults with well-controlled recurrent pericarditis. This Phase 2 study focuses on participants who have stable symptoms and have been treated with standard therapies such as NSAIDs, colchicine, glucocorticoids, or IL-1 pathway inhibitors. The goal is to understand the best dosing regimens for transitioning to KPL-387. Participants will receive KPL-387 through subcutaneous injections for up to 16 weeks during the Posology Study. Those who complete this phase may continue into a Long-Term Extension LTE phase lasting up to 24 months or until KPL-387 becomes commercially available for pericarditis treatment. Throughout both phases, participants will be monitored for symptoms, physical signs, laboratory markers like C-reactive protein, treatment tolerability, and pharmacokinetics. Any new or worsening symptoms will be managed according to the study protocol. During the study, participants will regularly report chest pain levels using a numerical rating scale and undergo physical and laboratory assessments. The research team will evaluate the proportion of participants free from pericarditis recurrence by Week 16 and monitor the annualized rate of recurrence during the LTE. Quality of life measures and safety follow-up visits continue after treatment ends. The total study participation may last up to two years, with ongoing monitoring to assess long-term outcomes and safety.

Transition to KPL-387 Monotherapy Dosing & Administration Study