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

InnoCare Pharma

Status and phase: Enrolling; Phase 3

Conditions: Plaque Psoriasis Patients

Treatments: Drug: ICP-488 Tablets; Drug: ICP-488 Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06842199

ICP-CL-01005

Details and patient eligibility

About

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.

Enrollment: 360 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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360 participants in 2 patient groups, including a placebo group

ICP-488 Tablets

Experimental group

Treatment:

Drug: ICP-488 Tablets

ICP-488 Placebo

Placebo Comparator group

Treatment:

Drug: ICP-488 Placebo