Recibokibart in GPP: Phase II trial results

Results from a multicenter, randomized, double-blind, placebo-controlled, phase II trial (NCT06231381) evaluating recibokibart, a humanized interleukin-36 (IL-36) receptor antibody, in 33 Chinese adults with moderate-to-severe acute generalized pustular psoriasis (GPP) were published in the British Journal of Dermatology by Yang et al. Patients were randomized 2:1 to receive recibokibart (n = 22) or placebo (n = 11). The primary endpoint was the proportion of patients attaining a GPP Physician’s Global Assessment (GPPGA) pustulation sub-score of 0 or 1 at Week 1. 

Key data: At Week 1, a greater proportion of patients receiving recibokibart vs placebo demonstrated a GPPGA pustulation sub-score of 0 or 1 (86.4% vs 9.1%; between group difference 77.5%, 95% confidence interval [CI], 42.5–88.9; p < 0.0001). Rates of GPPGA total score of 0 or 1 attainment (63.6% vs 0%; p = 0.0004) and complete pustule clearance (54.5% vs 0%; p = 0.0020) were also greater with recibokibart vs placebo. By Week 4, 72.7% of patients receiving recibokibart achieved a ≥75% improvement from baseline in the GPP Area and Severity Index (GPPASI75) vs 0% of patients receiving placebo (p < 0.0001). Clinical improvements were observed as early as 24 hours post-recibokibart treatment. During Week 1, rates of treatment-emergent adverse events (TEAEs) were similar between those receiving recibokibart vs placebo (72.7% vs 63.6%); the most common TEAEs with recibokibart were hyperlipidemia (13.6%), hypertriglyceridemia (13.6%), hypoproteinemia (13.6%), and pruritus (13.6%). 

Key learning: In this study, recibokibart demonstrated rapid, robust, and sustained improvements in pustular and overall skin disease severity in patients with moderate-to-severe acute GPP, supporting further evaluation in larger, longer-term studies.