Kiniksa Pharmaceuticals Announces Trial Design of Planned Phase 2/3 Clinical Trial of KPL-387 in Recurrent Pericarditis

Core Viewpoint - Kiniksa Pharmaceuticals is advancing its clinical trial for KPL-387, a monoclonal antibody targeting recurrent pericarditis, with a Phase 2/3 trial set to begin in mid-2025 and Phase 2 data expected in the second half of 2026 [1][2][3] Group 1: Clinical Trial Details - The Phase 2/3 clinical trial will evaluate the efficacy and safety of KPL-387 administered subcutaneously in patients with recurrent pericarditis, consisting of a dose-focusing portion, a pivotal portion, and long-term extensions [3][4] - The dose-focusing portion will enroll approximately 80 participants, randomized to receive different dosing regimens of KPL-387, with the primary efficacy endpoint being time to treatment response at Week 24 [4] - Following the dose-focusing portion, approximately 85 patients will be enrolled in the pivotal portion, which includes a single-blind run-in period followed by a double-blind randomized withdrawal period [5][6] Group 2: Drug Profile and Mechanism - KPL-387 is a fully human IgG2 monoclonal antibody that binds to the human interleukin-1 receptor 1 (IL-1R1), inhibiting the signaling of IL-1α and IL-1β cytokines [9][10] - The drug aims to provide a monthly dosing option via a single subcutaneous injection in a liquid formulation, potentially expanding treatment options for recurrent pericarditis patients [10] Group 3: Company Overview - Kiniksa Pharmaceuticals focuses on developing novel therapies for diseases with unmet needs, particularly in cardiovascular indications, and aims to improve the lives of patients suffering from debilitating diseases [8]