Innovent Biologics, Group. announced that the first patient with moderate-to-severe plaque psoriasis has been successfully dosed in a Phase 3 clinical trial (CLEAR) of picankibart (R&D code: IBI112), a recombinant anti-interleukin 23p19 subunit (IL23p19) antibody injection. The CLEAR study (clinicaltrials.gov, NCT05645627) is a multicenter, randomized, double-blind, placebo-controlled phase 3 clinical study to evaluate the efficacy and safety of picankibart in patients with moderate to severe plaque psoriasis.

This study plans to enroll approximately 500 subjects with moderate to severe plaque psoriasis. After 4 weeks of screening, subjects who met the eligibility criteria of the study will be randomized in a 2:2:1 ratio to picankibart group 1 (initial dose of 200mg and subsequently 200mg every 12 weeks thereafter), picankibart group 2 (initial dose of 200mg and subsequently 100mg every 12 weeks thereafter), or placebo group. The research period is expected to be 68 weeks.

The CLEAR study is the first phase 3 clinical study of IL-23 class innovative drugs in China. Innovent will continue to leverage its leading position in clinical development and guarantee the high quality of innovative drugs, and strive to provide better treatment options for psoriasis patients as soon as possible.