A Phase II Efficacy and Safety Study of HSK44459 in Subjects With Moderate to Severe Plaque Psoriasis

Patients with moderate to severe plaque psoriasis will be randomized into 3 cohorts (dose level 1, dose level 2 and placebo). Approximately 150 subjects will be enrolled. This study includes an 16-week treatment Period, then a 4-week safety visit period.

Inclusion criteria

• Fully understand and voluntarily participate this trial, and sign the informed consent form;
• Age≥18 years, regardless of gender;
• Plaque psoriasis;
• A candidate for systemic therapy;
• Agree to use a highly effective method(s) of from the signing of the informed consent form to 3 months post-treatment.

Exclusion criteria

• Can not discontinue the prohibited medications specified in the protocol before the first dose and throughout the entire study period;
• Laboratory abnormalities with clinical significance;
• Forms of psoriasis other than chronic plaque-type;
• Presence of other dermatological or autoimmune diseases;
• Presence of active infection requiring systemic therapy;
• Has undergone or plans to undergo major surgery;
• History of cardiovascular or cerebrovascular diseases;
• History of suicide attempts or major psychiatric disorders;
• History of malignant tumors;
• History of gastrointestinal surgery or diseases that may have impact on the study;
• History of drug abuse, illicit drug use, or alcohol abuse;
• History of severe drug allergies;
• Pregnant or lactating women;
• Subjects with any other factor considered by the investigator to be ineligible for participation in the trial.