Innovent Biologics’ Picankibart Achieves Success in Phase III CLEAR-1 Study for Moderate to Severe Plaque Psoriasis
- Innovent Biologics' Phase III CLEAR-1 trial of picankibart (IBI112) for treating moderate to severe plaque psoriasis in Chinese patients has met all primary and secondary endpoints.
- The multicentre, double-blind, placebo-controlled study involved 500 participants and evaluated the efficacy and safety of picankibart.
- The co-primary endpoints were the proportion of participants achieving a 90% or greater improvement from baseline Psoriasis Area and Severity Index (PASI 90) score and a static Physician's Global Assessment (sPGA) score of clear (0) or almost clear (1) at week 16.
- The results showed a swift and significant efficacy of picankibart, with a higher proportion of subjects achieving PASI 90 and sPGA 0 or 1 compared to placebo at week 16.
- CLEAR-1 is the first Phase III trial in the IL-23p19 class to report over 80% of subjects with psoriasis achieving PASI 90 after 16 weeks of treatment.
- Innovent plans to submit a new drug application for picankibart to the Center for Drug Evaluation of the National Medical Product Administration based on the CLEAR-1 results.