Phase 23 Study to Test Safety and Effectiveness of KPL-387 for Treating Recurrent Pericarditis

What this Trial Is About

Researchers are studying the effects of KPL-387 in people with recurrent pericarditis, a condition marked by repeated inflammation of the pericardium, the lining around the heart. This clinical trial includes Phase 2, Phase 3, and a Long-Term Extension to evaluate how well KPL-387 controls pain and inflammation during acute episodes and to reduce the risk of recurrence. The study also aims to assess the safety, tolerability, blood levels of KPL-387, and its impact on immune markers related to recurrent pericarditis. Participants in Phase 2 will receive different dose levels of KPL-387 by subcutaneous injection every two weeks through Week 22 to determine the most effective dose. Phase 3 will then confirm the efficacy of the chosen dose by comparing KPL-387 to a placebo, also given by subcutaneous injection at similar intervals. Those who complete Phase 2 or Phase 3 may join the Long-Term Extension, where KPL-387 is given to maintain disease control and study long-term effects. Throughout the trial, participants will be regularly evaluated for treatment response, time to symptom relief, normalization of inflammation markers, and pain levels using questionnaires and clinical tests like echocardiograms and electrocardiograms. Researchers will monitor safety and disease recurrence up to 24 months in the extension phase. The study runs from July 2025 to December 2029, involving multiple visits for injections and assessments during treatment and follow-up periods.

Phase 2/3 Study of Participants With Recurrent Pericarditis Evaluating the Efficacy and Safety of KPL-387