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

Study Overview
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Brief Summary
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This is a multicenter, randomized, double-blind, placebo-controlled Phase II clinical study to evaluate ICP-488.Efficacy, safety, PK, and PD characteristics in Chinese adults with moderate to severe plaque psoriasis.

Official Title
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A Randomized, Double-blind, Placebo-controlled Phase II Clinical Study Evaluating the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of ICP-488 in Patients With Moderate to Severe Plaque Psoriasis

Conditions
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Moderate to Severe Plaque Psoriasis

Intervention / Treatment
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* Drug: ICP-488 Tablets
* Drug: ICP-488 Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects voluntarily participate in this study and have signed informed consent. Male or female subjects between the ages of 18 and 70 (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. 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, dietary supplements or food (e.g., grapefruit or grapefruit juice) 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ICP-488 low dose<br> | Drug: ICP-488 Tablets<br>* ICP-488 will be administered as tablet<br>Drug: ICP-488 Placebo<br>* ICP-488 Placebo will be administered as tablet<br>|
| Experimental: ICP-488 high dose<br> | Drug: ICP-488 Tablets<br>* ICP-488 will be administered as tablet<br>|
| Placebo Comparator: Placebo<br> | Drug: ICP-488 Placebo<br>* ICP-488 Placebo will be administered as tablet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of subjects who achieved a PASI 75 response (a reduction of minimum 75% from baseline in PASI score) at Week 12. | Proportion of subjects who achieved PASI 75 (PASI score improvement of at least 75% from baseline) at week 12. | Baseline up to Week 12 |