The primary objective of this study is to evaluate the efficacy of HS-20118 compared with placebo in participants with moderate to severe plaque psoriasis.
Participants voluntarily agree to comply with all study procedures and scheduled follow-up assessments, and to cooperate with the collection of lesion photographs and other protocol-specified requirements;
Diagnosis of plaque psoriasis, with or without PsA, established for at least 26 weeks prior to the first administration of study intervention. If previously diagnosed with psoriasis, participants must have a documented history of psoriasis for at least 26 weeks and must be confirmed by the investigator during screening to have plaque psoriasis;
Known allergy, hypersensitivity, or intolerance to biologics, study drugs, or their excipients.
Non-plaque psoriasis (e.g., guttate, erythrodermic, pustular, or drug-induced psoriasis) at screening or randomization.
Other skin lesions or systemic autoimmune diseases (e.g., systemic lupus erythematosus, Sjögren's syndrome, scleroderma) that may affect the safety and efficacy assessment of the study drug.
Other skin lesions or systemic autoimmune diseases (e.g., systemic lupus erythematosus, Sjögren's syndrome, scleroderma) that may affect the safety and efficacy assessment of the study drug.
Parallel
HS-20118
DrugAdministered orally, once weekly (QW)
Placebo
DrugAdministered orally, once weekly (QW)
Proportion of participants achieving PASI 75 (≥75% improvement from baseline in PASI) at Week 16
Percentage of participants achieving PASI 75 response (\>=75% improvement in PASI from baseline) at Week 16 will be reported. The PASI is a system for assessing/grading psoriatic lesion severity and treatment response. It divides the body into 4 regions (head, trunk, upper extremities, lower extremities), with each region separately scored for erythema, induration, scaling (0-4 scale each) and involvement extent (0-6 scale). PASI yields a 0-72 numeric score, where higher scores mean more severe disease.
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