Efficacy, Safety, Pharmacokinetics of ICP-488 in Patients With Moderate to Severe Plaque Psoriasis
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of Oral ICP-488 in Patients With Moderate to Severe Plaque Psoriasis
Beijing InnoCare Pharma Tech Co., Ltd.
383 participants
Mar 20, 2025
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria6
- 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 Criteria10
- 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.
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Interventions
Eligible patients will receive ICP-488 orally as per the protocol
Eligible patients will receive ICP-488 Placebo orally as per the protocol
Locations(46)
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NCT06842199