P62 Efficacy and safety of picankibart in moderate-to-severe plaque psoriasis: a randomized, double-blind, Phase 3 CLEAR-1 trial

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Abstract The aim of this study was to evaluate the efficacy and safety of picankibart (an inhibitor of the interleukin-23 p19 subunit) compared with placebo in patients with moderate-to-severe plaque psoriasis. CLEAR-1 was a Phase 3, randomized, double-blind, placebo-controlled trial. Eligible patients between 18 and 75 years old who had a diagnosis of moderate-to-severe plaque psoriasis for at least 6 months [body surface area involvement ≥10%, psoriasis area and severity index (PASI) ≥12, and static Physician’s Global Assessment (sPGA) ≥3] at screening and baseline visits were randomly assigned at a 2:2:1 ratio to receive 200 mg picankibart at Week 0, 4, and 8 followed by 200 mg picankibart every 12 weeks at Week 20, 32, and 44; 200 mg picankibart at Week 0, 4, and 8 followed by 100 mg picankibart every 12 weeks at Weeks 20, 32, and 44; or placebo at Weeks 0, 4, and 8 followed by 200 mg picankibart at Weeks 16, 20, 24, 32, and 44. Co-primary endpoints were the proportions of patients achieving ≥90% improvement from baseline in PASI (PASI 90) and a sPGA score of 0 or 1 at Week 16 (superiority comparison of picankibart 200 mg with placebo) assessed in the intention-to-treat population. A total of 500 patients were randomly assigned to receive 200 mg picankibart through Week 52 (n = 199), 200 mg picnakibart for 16 weeks followed by 100 mg from Week 16 to Week 52 (n = 202), or placebo followed by 200 mg picankibart (n = 99). The mean age of patients was 41.9 years (standard deviation 12.0), 384 (76.8%) were men; baseline characteristics were balanced across treatment groups. Co-primary endpoints were met. At Week 16, PASI 90 was achieved by 322 (80.3%) patients receiving picankibart vs. 2 (2.0%) receiving placebo [difference 78.3% (95% confidence interval (CI) 73.5–83.1%); P < 0.0001], and sPGA 0 or 1 was achieved by 375 (93.5%) patients receiving picankibart vs. 13 (13.1%) receiving placebo [difference 80.4% (95% CI 73.4–87.5%); P < 0.0001]. Picankibart also showed superiority to placebo regarding all key secondary endpoints (P < 0.0001). The improvements were maintained at Week 52 for patients receiving 200 mg or 100 mg picankibart. The rate of treatment-emergent adverse events was similar between picankibart and placebo groups. No new safety signal was noted during the maintenance period. Picankibart showed superior efficacy to placebo in the treatment of moderate-to-severe plaque psoriasis. The safety profile of picankibart was favourable with no unexpected safety findings.