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

Published: 2025-06-05 08:05:38 ET KNSA

Published on 06/05/2025 at 08:05

Kiniksa Pharmaceuticals International, plc announced details for its planned Phase 2/3 clinical trial of KPL-387 in recurrent pericarditis, expected to initiate in the middle of 2025. KPL-387 is an independently developed monoclonal antibody that binds human interleukin-1 receptor 1 (IL-1R1), inhibiting the signaling activity of the cytokines interleukin-1a (IL-1a) and interleukin-1b (IL-1b). Phase 2/3 Clinical Trial of KPL-387 in Recurrent Pericarditis: Kiniksa is on track to initiate a Phase 2/3 clinical trial designed to evaluate the efficacy and safety of KPL-387 administered subcutaneously (SC) in patients with recurrent pericarditis.

The trial will consist of three overlapping parts combined into a single protocol: a dose-focusing portion (Phase 2), a pivotal portion (Phase 3), and long-term extensions (LTE). The dose-focusing portion of the trial will enroll up to approximately 80 participants with recurrent pericarditis randomized in a 1:1:1:1 ratio to receive KPL-387 300 mg SC biweekly, 300 mg SC monthly, 100 mg SC biweekly, and 100 mg SC monthly. The primary efficacy endpoint is time to treatment response at Week 24.

Subsequently, active, enrolled participants may be eligible to enter an LTE. Following the dose-focusing portion, enrollment of up to approximately 85 patients with recurrent pericard inflammation into the pivotal portion of the clinical trial will commence. In the first period, a single-blind run-in (RI), all participants will receive KPL-387 while conventional oral pericarditis medications are weaned and discontinued.

Participants achieving Clinical Response in the RI period will then be randomized in a 1:1 ratio to receive either KPL-387 or placebo in an event-driven, double-blind, randomized withdrawal (RW) period. The primary efficacy endpoint istime to first-adjudicated pericarditis recurrence during the RW period. Participants in the RW period may be eligible to enter an IoT.

The Phase 2/3 clinical trial design is supported by data from the Phase 1 first-in-human single ascending dose study.