CLEAR‑1 phase III: Picankibart in Chinese patients with moderate-to-severe plaque PsO

Results from the multicenter, randomized, double-blinded, placebo-controlled phase III CLEAR‑1 (NCT05645627) trial, evaluating picankibart, a humanized anti-interleukin‑23p19 (IL‑23p19) monoclonal antibody, in 500 Chinese adults with moderate-to-severe plaque psoriasis (PsO), were recently published in the Journal of the American Academy of Dermatology by Gao et al. The primary efficacy endpoints were the proportion of patients achieving ≥90% reduction in Psoriasis Area and Severity Index (PASI90) and the proportion of patients achieving a static Physician’s Global Assessment (sPGA) score of clear or almost clear (sPGA 0/1) at Week 16. Key secondary endpoints included ≥75% reduction in PASI (PASI75), 100% reduction in PASI (PASI100), sPGA 0, and a Dermatology Life Quality Index (DLQI) of 0/1 at Week 16. 

Key data: At Week 16, 80.3% of patients receiving picankibart demonstrated PASI90 (95% confidence interval [CI], 76.4–84.2) vs 2.0% with placebo (95% CI, 0–4.8; p < 0.0001). An sPGA 0/1 was reported in 93.5% of patients in the picankibart group (95% CI, 91.1–95.9) vs 13.1% in the placebo group (95% CI, 6.5–19.8; p < 0.0001). PASI75 and PASI100 response rates were 94.3% vs 11.1% (p < 0.0001) and 40.9% vs 1.0% (p < 0.0001) in the picankibart and placebo groups, respectively. An sPGA 0 was demonstrated in 56.9% of patients receiving picankibart vs 1.0% of patients receiving placebo (p < 0.0001). At Week 16, 53.7% vs 0% of patients had a DLQI of 0/1 (p < 0.0001). Treatment-related adverse events (TRAEs) occurred in 53.5% of patients receiving picankibart vs 40.2% of patients receiving placebo. Efficacy was sustained through Week 52 at both 100 mg and 200 mg dose levels. 

Key learning: Picankibart demonstrated sustained skin clearance in Chinese adults with moderate-to-severe plaque PsO, with a favorable safety profile, supporting picankibart as a therapeutic option in this population.