This is a multicenter, randomized, double-blind, placebo-controlled Phase III clinical study to evaluate the efficacy, safety, PK characteristics of ICP-488 in Chinese adults with moderate to severe plaque psoriasis.
Subjects voluntarily participate in this study and have signed informed consent.
Male or female subjects between the ages of 18 and 75 (including the threshold) at the time of signing the ICF.
History of plaque psoriasis ≥6 months at baseline.
Subjects need to receive systemic therapy and/or phototherapy.
The diagnosis was non-plaque psoriasis.
Subjects with concurrent skin diseases that the investigator believes would interfere with the study assessments.
Presence of infection or immune-related disease.
Subjects with a history of TB or at risk for TB.
Parallel
ICP-488 Tablets
DrugEligible patients will receive ICP-488 orally as per the protocol
ICP-488 Placebo
DrugEligible patients will receive ICP-488 Placebo orally as per the protocol
The proportion of subjects who achieve a score of clear (0) or almost clear (1) with an improvement of at least 2 points from baseline on the static Physician's Global Assessment (sPGA) at week 16
Percentage of subjects who achieved a PASI 75 response (a reduction of minimum 75% from baseline in PASI score) at Week 16
Adverse events
Percentage of subjects with PASI 50/75/90/100 in each planned visit
Percentage of subjects with sPGA score of 0 (clear) or 1 (almost clear) and an improvement of at least 2 points from baseline in planned visits.
The proportion of subjects with sPGA score of 0 in each planned visit.
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