Kiniksa Pharmaceuticals announced the detailed design for its planned Phase 2/3 clinical trial of KPL-387 in recurrent pericarditis, which is on track to initiate in mid-2025. Data from the Phase 2 portion of this trial are expected in the second half of 2026.
KPL-387 is an independently developed monoclonal antibody designed to inhibit IL-1α and IL-1β signaling, with Phase 1 data supporting a target profile of monthly subcutaneous dosing in a liquid formulation. This aims to provide a more convenient treatment option for patients.
The trial will feature three overlapping parts: a dose-focusing Phase 2, a pivotal Phase 3, and long-term extensions. The Phase 2 portion will enroll up to approximately 80 participants, randomized to receive KPL-387 at various doses and biweekly or monthly regimens.
The primary efficacy endpoint for the dose-focusing portion is time to treatment response at Week 24. Following this, the pivotal Phase 3 portion will enroll up to approximately 85 patients, further evaluating the drug's efficacy and safety.
In the pivotal portion, participants achieving Clinical Response during a single-blind run-in period will be randomized 1:1 to receive either KPL-387 or placebo in an event-driven, double-blind, randomized withdrawal period. The primary efficacy endpoint for this period is time to first-adjudicated pericarditis recurrence.
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