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.

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.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

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.