Institute of Good Manufacturing Practices India®

(An Autonomous Body Recognized by Ministry of Commerce & Industry, Government of India)

Innovent’s phase 3 study of picankibart for treating moderate to severe plaque psoriasis meets all primary and key secondary endpoints

Innovent Biologics, Inc., a renowned biopharmaceutical firm focusing on cancer, metabolic, autoimmune, and other diseases, has revealed the success of its phase 3 study, CLEAR-1, assessing picankibart, a recombinant anti-interleukin 23p19 subunit (IL-23p19) antibody injection, in Chinese patients with moderate to severe plaque psoriasis. The trial met all primary and key secondary endpoints, with over 80% of subjects achieving PASI 90 after 16 weeks, marking a significant advancement in IL-23p19 class treatment. Innovent plans to submit a new drug application for picankibart to the Center for Drug Evaluation (CDE) of the National Medical Product Administration (NMPA). CLEAR-1, a multicenter, randomized, double-blind, placebo-controlled phase 3 study, involved 500 subjects. Picankibart demonstrated rapid and substantial efficacy, meeting co-primary endpoints with significantly higher PASI 90 and sPGA 0/1 rates compared to placebo at week 16. The long-term efficacy and favorable safety profile highlight picankibart's potential as a promising treatment option for moderate to severe psoriasis.