This is a prospective, single-arm, multicenter, Phase IV study of 1564 patients with moderate-to-severe chronic plaque psoriasis to evaluate the efficacy and safety of Vunakizumab in patients with moderate-to-severe plaque psoriasis who have converted from other biologics. To explore the efficacy of difficult-to-treat area, patient satisfaction and patient-reported outcomes (PRO).
Age ≥18 years old at the time of signing the informed consent, regardless of gender;
Diagnosed with moderate to severe plaque psoriasis;
The subject voluntarily signs informed consent before the start of any procedures related to the study, can communicate with the researcher smoothly, understands and is willing to strictly comply with the requirements of this clinical study protocol to complete the study;
Patients who have been treated with biologics for ≥12 weeks prior to screening and are in line with the biologics conversion recommendations of the Chinese Guidelines for the Treatment of Psoriasis Biologics and Small Molecule Drugs (2024 edition), and who have been screened and evaluated by researchers as eligible for biologics therapy.
Patients previously treated with IL-17A inhibitors (IL-17Ai) had primary failure;
Patients who had previously used IL-17A inhibitors (IL-17Ai) and experienced drug-related adverse events leading to drug withdrawal;
Patients with severe hypersensitivity to the active ingredient or any excipients of Vunakizumab;
Fertile women (defined as all women with physical conditions necessary for pregnancy) and men who are pregnant or unwilling or unable to use highly effective birth control during the study period and within 20 weeks after the last receipt of the study drug;
Single group
Vunakizumab (IL-17A inhibitor)
DrugVunakizumab (IL-17A inhibitor)
The proportion of subjects who achieved at least a 90% improvement from baseline in PASI scores by week 12 (PASI 90).
Proportion of subjects achieving sPGA 0/1 response at week 12.
Proportion of subjects with PASI 75, PASI 90, PASI 100, sPGA 0/1, and sPGA 0 at week 4, 12, and 52.
The time when subjects reached PASI 75 and PASI 90 within 12 weeks
The time when subjects reached PASI 75, PASI 90, PASI 100 within 52 weeks.
Changes in PASI scores relative to baseline at each visit during 52 weeks.
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