Chinese biopharmaceutical company Innovent Biologics Inc (HKEX:01801) announced on Wednesday that the first participant has been successfully dosed in a Phase 3 clinical study of picankibart (recombinant anti-interleukin 23p19 subunit [IL-23p19] antibody, R&D code: IB112).
This is the first randomised, double-blind, controlled Phase 3 clinical study evaluating biologics switching in psoriasis patients with prior inadequate response to anti-IL-17 antibody. It will evaluate the efficacy of picankibart in difficult-to-treat psoriasis patients who had inadequate response to prior anti-IL-17 treatment, with the control group continuing to receive IL-17 inhibitors. The company says that the results are expected to provide robust clinical evidence supporting picankibart's therapeutic advantages in this challenging patient population.
The multi-centre study is planned to enrol approximately 310 participants, who will be randomised in a 1:1 ratio to the picankibart treatment group or the continued IL-17 monoclonal antibody treatment group. The primary endpoint is the proportion of participants achieving a static Physician's Global Assessment (sPGA) score of clear (0) or almost clear (1) at week 16.
A Phase 2 study showed that switching from other biologics (primarily IL-17 monoclonal antibodies) to picankibart led to a rapid clinical response.
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