The trial is designed to assess the efficacy and safety of picankibart in Chinese patients with moderate to severe plaque psoriasis. Credit: TY Lim / Shutterstock.

Chinese biopharmaceutical company Innovent Biologics has reported that its Phase III CLEAR-1 study of picankibart (IBI112) for treating moderate to severe plaque psoriasis met all its primary and key secondary endpoints.

The multicentre, double-blind, placebo-controlled study enrolled 500 subjects, who were randomised to receive either placebo or picankibart in varying doses.

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It aimed to assess the efficacy and safety of picankibart in Chinese patients with moderate to severe plaque psoriasis.

The proportion of participants attaining a 90% or greater improvement from baseline Psoriasis Area and Severity Index score (PASI 90) and a static Physician’s Global Assessment (sPGA) score of clear (0) or almost clear (1) at week 16 were the trial’s co-primary endpoints.

The results showed a rapid and significant efficacy of picankibart, with a notably higher proportion of subjects achieving PASI 90 and sPGA 0 or 1 versus placebo at week 16, meeting the co-primary endpoints.

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CLEAR-1 is claimed to be the first Phase III trial in the IL-23p19 class to report more than 80% of subjects with psoriasis achieving PASI 90 after 16 weeks of treatment.

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Based on these positive outcomes, Innovent intends to file a new drug application for picankibart with the Center for Drug Evaluation of the National Medical Product Administration.

Innovent Clinical Development vice-president Dr Lei Qian said: “Achievement of all primary and key secondary endpoints in CLEAR-1 has supported picankibart’s outstanding efficacy and favourable safety as a new generation of IL-23p19 target drugs.

“We will actively prepare to submit the new drug application of picankibart based on the CLEAR-1 results, and strive to provide a more convenient, friendly and effective treatment regimen for patients with moderate to severe plaque psoriasis.”

Earlier this month, Innovent reported that its type 2 diabetes candidate mazdutide was superior to Eli Lilly’s Trulicity (dulaglutide) in a Phase III trial.