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

Beijing InnoCare Pharma Tech Co., Ltd.31 sites in 1 country129 target enrollmentJanuary 4, 2024

ConditionsModerate to Severe Plaque Psoriasis

InterventionsICP-488 Placebo ICP-488 Tablets

DrugsICP-488 Tablets ICP-488 Placebo

Overview

Phase: Phase 2
Intervention: ICP-488 Placebo
Conditions: Moderate to Severe Plaque Psoriasis
Sponsor: Beijing InnoCare Pharma Tech Co., Ltd.
Enrollment: 129
Locations: 31
Primary Endpoint: Percentage of subjects who achieved a PASI 75 response (a reduction of minimum 75% from baseline in PASI score) at Week 12.
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

January 4, 2024

End Date

September 18, 2024

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Beijing InnoCare Pharma Tech Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

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 halflife data) from the last dose of a strong CYP1A2 inhibitor or inducer, or a plan to use concurrently medications, dietary supplements or food with strong CYP1A2 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.