Efficacy, Safety, Pharmacokinetics of ICP-488 in Patients With Moderate to Severe Plaque Psoriasis

Inclusion criteria

Eligible subjects must meet all of the following criteria:

• 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 following three criteria were met: a) psoriasis Area and Severity index (PASI) score ≥12; b) Psoriasis affected body surface area (BSA) ≥10%; c) Static physician overall assessment (sPGA) ≥3 scores

Exclusion criteria

• 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.
• Received related treatment within the time window specified in the protocol.
• An interval of less than 5 half-lives or 28 days (if any available half-life data) from the last dose of a strong CYP1A2/CYP3A4 inhibitor or inducer, or a plan to use concurrently medications with strong CYP1A2/CYP3A4 inhibitory or inductive effect during study participation.
• The investigator has determined that there are clinically significant test results and that participation in this trial would pose an unacceptable risk to patients; Or the laboratory values of the subjects in the screening period meet the criteria specified in the protocol.
• Pregnant or lactating women, or women who plan to become pregnant during study participation.
• A history of severe drug allergies.
• Any other conditions in which the investigator considers it unsuitable for the subject to participate in this study.