The purpose of this study is to assess the efficacy and safety of HSK44459 administered orally for moderate to severe plaque psoriasis in adults.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Proportion of subjects who have ≥75% reduction in PASI (PASI-75). — 16 weeks The proportion of subjects who have a reduction of 75% or more from baseline in the psoriasis area-and-severity index score (PASI 75) at week 16.
Trial sites (1)
Facility
City
Region
Status
Hangzhou First People's Hospital
Hangzhou
Zhejiang
More Haisco Pharmaceutical Group Co., Ltd. trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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