P14 A multicentre, randomized, double-blind, placebo-controlled Phase II study to evaluate the efficacy and safety of individual dose regimens of HB0017 in patients with moderate-to-severe plaque psoriasis

Abstract HB0017 is a recombinant humanized IgG1 monoclonal antibody that targets IL-17A. To investigate HB0017 optimal dosage and possible dosing interval during maintenance therapy to inform Phase III studies. A total of 81 patients with moderate-to-severe plaque psoriasis received HB0017 300 mg (n = 41) or placebo (n = 40) at Weeks 0, 1, 2, 4, and 8. From Week 12 to Week 28, patients in the HB0017 group were given HB0017 300 mg once every 8 weeks. And patients in the placebo group were given HB0017 300 mg at Week 12, 13, 14 and 16, and then every 4 weeks until Week 28. Efficacy, safety, pharmacokinetics, and immunogenicity were assessed in Week 36. After 12 weeks of treatment, HB0017 300 mg resulted in significantly higher PASI 90 and sPGA0/1 response rates vs. placebo (P < 0.001). At Week 12, in the HB0017 group, 69.4% of patients achieved PASI 90, increasing to 97.6% at Week 24, then maintained throughout the follow-up period. And 78.2% of patients achieved sPGA0/1, increased to comparable peak levels at Week 28(97.6%), then maintained to Week 36(97.5%). In the placebo group, 1.0% of patients achieved PASI 90 at Week 12, increased to 94.3% at Week 28, then maintained throughout the follow-up period. 1.1% of patients achieved sPGA0/1, increased to 91.2% at Week 24, then maintained to Week 36(91.4%). The overall safety profile of HB0017 was similar to those of similar drugs, and no new safety signals were identified. These data provide evidence to support the evaluation of HB0017 300 mg maintenance dosing both every 8 and every 4 weeks in Phase III clinical trials.