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

RecruitingPhase 3Ages 18 Years - 75 YearsAllBeijing InnoCare Pharma Tech Co., Ltd.
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: Eligible subjects must meet all of the following criteria: 1. Subjects voluntarily participate in this study and have signed informed consent. 2. Male or female subjects between the ages of 18 and 75 (including the threshold) at the time of signing the ICF. 3. History of plaque psoriasis ≥6 months at baseline. 4. Subjects need to receive systemic therapy and/or phototherapy. 5. 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: 1. The diagnosis was non-plaque psoriasis. 2. Subjects with concurrent skin diseases that the investigator believes would interfere with the study assessments. 3. Presence of infection or immune-related disease. 4. Subjects with a history of TB or at risk for TB. 5. Received related treatment within the time window specified in the protocol. 6. 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. 7. 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. 8. Pregnant or lactating women, or women who plan to become pregnant during study participation. 9. A history of severe drug allergies. 10. Any other conditions in which the investigator considers it unsuitable for the subject to participate in this study.
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What it tests

  • ICP-488 Tablets
  • ICP-488 Placebo
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Where

46 sites
The First Affiliated Hospital of Anhui Medical University
Hefei, China
The Second Affiliated Hospital of Wannan Medical College
Wuhu, China
Beijing Chao-Yang Hospital,Capital Medical University
Beijing, China
Beijing Friendship Hospital, Capital Medical University
Beijing, China
Peking University Third Hospital
Beijing, China
Beijing Tongren Hospital,CMU
Beijing, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, China
Chongqing Traditional Chinese Medicine Hospital
Chongqing, China

…and 38 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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