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

Launched by BEIJING INNOCARE PHARMA TECH CO., LTD. · Feb 21, 2025

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment called ICP-488 for adults with moderate to severe plaque psoriasis, a skin condition that causes red, scaly patches. The study is taking place at multiple centers and is designed to determine how effective and safe this medication is compared to a placebo (a treatment that has no active drug). The trial is currently recruiting participants aged 18 to 75 who have had plaque psoriasis for at least six months and require systemic therapy (medications that affect the entire body) or phototherapy (light treatment).

To be eligible for this study, participants must meet specific criteria, such as having a certain level of psoriasis severity and a significant area of their skin affected. Those who have other types of skin diseases, infections, or certain health conditions, or who are pregnant or breastfeeding, cannot participate. If you join this trial, you can expect to receive either the new treatment or a placebo, and you will be monitored closely for any side effects or changes in your condition. This trial aims to provide more options for managing plaque psoriasis effectively.

Gender

ALL

Eligibility criteria

• 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, dietary supplements or food (e.g., grapefruit or grapefruit juice) 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.