The trial will enrol nearly 500 patients with moderate to severe plaque psoriasis. Credit: Martin Trotter/ Flickr (Creative Commons).

Innovent Biologics Group has dosed the first participant in the Phase III CLEAR clinical trial of the anti-interleukin 23p19 subunit (IL23p19) antibody injection, picankibart, in moderate-to-severe plaque psoriasis patients.

The placebo-controlled, multicentre, double-blind Phase III clinical trial has been designed for assessing picankibart’s safety and efficacy in these patients.

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Nearly 500 moderate to severe plaque psoriasis patients are planned to be enrolled in the trial.

Participants who meet the study eligibility criteria will be randomised into a 2:2:1 ratio to picankibart group 1, picankibart group 2, or a placebo group after screening for four weeks.

The company expects the research period to be 68 weeks.

See Also:

CLEAR is the first Phase III study of IL-23 class innovative drugs in China.

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Innovent Biologics Group Clinical Development vice-president Dr Qian Lei said: “The new generation of drugs targeting IL-23 has shown excellent efficacy and good safety, especially compared with anti-IL-17 monoclonal antibody drugs.

“Picankibart, independently developed by Innovent, is the first anti-IL23p19 antibody drug which has completed Phase II clinical study in Chinese patients with moderate-to-severe plaque psoriasis, and has obtained good efficacy and safety results.

“It also showed the obvious advantages of long-dose interval and long-term efficacy. At week 52, 66.7%~86.0% of the subjects who received picankibart achieving PASI90, 81.6%~88.0% of the subjects achieved PASI 75, and in one of the groups received picankibart, about 48.0 % of subjects achieved complete skin lesions clearance (PASI 100).”

Picankibart works by specifically binding to IL-23p19 subunit, then preventing IL-23 from binding to cell surface receptors. This results in IL-23 receptor-mediated signalling pathway inhibition.