A multicenter, randomized, double-blinded, placebo-controlled phase III trial to evaluate efficacy and safety of picankibart in moderate-to-severe plaque psoriasis.

Abstract

The development of interleukin-23 inhibitors that offer sustained complete skin clearance with reduced-frequency dosing addresses a significant unmet clinical need in managing moderate-to-severe plaque psoriasis. To evaluate the efficacy and safety of picankibart, an interleukin-23p19 inhibitor, in Chinese patients. CLEAR-1 enrolled participants aged 18-75 years to randomly receive picankibart subcutaneously 200 mg at weeks 0/4/8/20/32/44, picankibart 200 mg at weeks 0/4/8 then 100 mg at weeks 20/32/44; or placebo at weeks 0/4/8 then picankibart 200 mg at weeks 16/20/24/32/44. The co-primary endpoints were ≥90% improvement in psoriasis area and severity index and static physician's global assessment clear/almost clear status (0/1) at week 16. In picankibart 200 mg group, 80.3% achieved ≥90% improvement in psoriasis area and severity index and 93.5% achieved static physician's global assessment 0/1 at week 16 vs 2.0% and 13.1%, respectively with placebo. All key secondary endpoints were significantly improved (all two-sided P < .0001 vs placebo). Efficacy was maintained through week 52 for both 100 mg and 200 mg doses, with no new safety signal observed. Chinese only; no active comparator. Picankibart provided effective skin clearance in Chinese participants by week 16. A dosing regimen of every 12 weeks with either 100 mg or 200 mg maintained these clinical improvements through week 52.