Safety, Pharmacokinetics, and Efficiency of JS005, a Novel Antiinterleukin-17A Monoclonal Antibody, in Healthy Chinese Adults and Patients with Moderate to Severe Psoriasis

Abstract

JS005 is a novel anti-IL-17A monoclonal antibody. A Phase Ia study (Study 1) in healthy adults, followed by a Phase Ib/II study (Study 2) in patients with moderate to severe plaque psoriasis (PsO), were designed to evaluate the safety, efficacy, and pharmacokinetic characteristics of JS005. Study 1 was a double-blind, randomized, placebo-controlled, single dose-escalation (15, 60, 150, 300, and 600 mg) study. Forty healthy participants were enrolled. Study 2 consisted of a dose-escalation (60, 150, 300, or 600 mg) phase Ib, and a multicentre, double-blind, placebo-controlled phase II administering JS005 150, 300 mg, or placebo once weekly from week 0 to 4 and once every 4 weeks from week 5 to 12. Forty and 143 patients were enrolled in phases Ib and II, respectively. The exposure of JS005 increased linearly with dosage, while the treatmentemergent adverse events did not show this trend. JS005 was well tolerated in both populations. In phase II of Study 2, the proportion of patients with at least a 75% improvement in the Psoriasis Area and Severity Index at week 12 was significantly higher in each JS005 group than in the placebo group (p<0.001 for all comparisons). JS005 was highly effective in PsO patients.