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.
Go deeper with GlobalData
Discover B2B Marketing That Performs
Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms.
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.
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.
US Tariffs are shifting - will you react or anticipate?
Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis.
By GlobalDataBased 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.
