CLEAR-1 is global the first Phase 3 registration study in IL-23p19 class that reported over 80% of subjects achieved PASI 90 after 16 weeks of treatment in psoriasis patients. Innovent plans to submit a new drug application (NDA) for picankibart in the treatment of psoriasis to the
Dosing interval set to 12 weeks
CLEAR-1 (NCT05645627) is a multicenter, randomized, double-blind, placebo-controlled Phase 3 study to evaluate the efficacy and safety of picankibart in subjects with moderate to severe plaque psoriasis. A total of 500 subjects were enrolled and randomized in a 1: 2: 2 ratio to receive placebo or picankibart 200 mg every 4 weeks at week 0, 4 and 8 followed by 200 mg or 100 mg every 12 weeks. Co-primary endpoints were the proportion of subjects achieving 90% improvement from baseline Psoriasis Area and Severity Index score (PASI 90) and the proportion of subjects achieving a static Physician's Global Assessment (sPGA) score of clear (0) or almost clear (1) at week 16.
The co-primary endpoints were successfully met, showing a rapid and significant efficacy of picankibart
The study results showed that co-primary endpoints of CLEAR-1 were successfully met: at week 16, significantly higher proportion of subjects receiving picankibart achieved PASI 90 and sPGA 0 or 1 compared with placebo (80.3% vs. 2.0% for PASI 90 and 93.5% vs. 13.1% for sPGA 0/1, both p
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