Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of ICP-488 in Patients with Moderate to Severe Plaque Psoriasis

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

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.

Study Overview

• Status: Completed
• Conditions: Moderate to Severe Plaque Psoriasis
• Intervention / Treatment: Drug: ICP-488 Tablets; Drug: ICP-488 Placebo

• Study Type: Interventional
• Enrollment (Actual): 129
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100000
      • Beijing Friendship Hospital, Capital Medical University
    • Beijing, Beijing, China, 100000
      • China-Japan Friendship Hospital
  • Chongqing
    • Chongqing, Chongqing, China, 400000
      • The First Affiliated Hospital of Chongqing Medical University
  • Fujian
    • Fuzhou, Fujian, China, 350000
      • The First Affiliated Hospital of Fujian Medical University
  • Guangdong
    • Guangzhou, Guangdong, China, 510120
      • Guangdong Hospital of Traditional Chinese Medicine
    • Guangzhou, Guangdong, China, 510000
      • Dermatology Hospital of Southern Medical University
  • Guizhou
    • Guiyang, Guizhou, China, 550081
      • Affiliated Hospital of Guizhou Medical University
  • Hebei
    • Chengde, Hebei, China, 067032
      • The Affiliated Hospital of Chengde Medical College
    • Shijia Zhuang, Hebei, China, 050000
      • The First Hospital of Hebei Medical University
    • Shijiazhuang, Hebei, China, 050000
      • The Second Affiliated Hospital of Hebei Medical University
  • Henan
    • Nanyang, Henan, China, 473000
      • Nanyang city first People's Hospital
    • Zhengzhou, Henan, China, 450000
      • Henan Provincial People's Hospital
  • Hubei
    • Shiyan, Hubei, China, 442000
      • Shiyan City People's Hospital
    • Wuhan, Hubei, China, 430000
      • Wuhan University People's Hospital
    • Wuhan, Hubei, China, 430030
      • Wuhan No.1 Hospital
  • Hunan
    • Changsha, Hunan, China, 410008
      • Xiangya Hospital Central South University
  • Inner Mongolia Autonomous Region
    • Hohhot, Inner Mongolia Autonomous Region, China, 010000
      • Affiliated Hospital of Inner Mongolia Medical University
  • Jiangsu
    • Changzhou, Jiangsu, China, 213000
      • Changzhou First People's Hospital
    • Lianyungang, Jiangsu, China, 222000
      • Lianyungang First People's Hospital
    • Nanjing, Jiangsu, China, 210042
      • Hospital for Skin Diseases, Institute of Dermatology, Chinese Academy of Medical Sciences, Peking Union Medical College
  • Jilin
    • Changchun, Jilin, China, 130000
      • First Hospital of Jilin University
    • Meihekou, Jilin, China, 135099
      • Mei he kou central hospital
  • Shandong
    • Jinan, Shandong, China, 250013
      • Central Hospital affiliated to shandong first medical unversity
  • Shanghai
    • Shanghai, Shanghai, China, 200040
      • Huashan Hospital Affiliated to Fudan University
    • Shanghai, Shanghai, China, 200000
      • Shanghai Dermatology Hospital
  • Sichuan
    • Chengdu, Sichuan, China, 610000
      • Chengdu Second People's Hospital
  • Yunnan
    • Kunming, Yunnan, China, 650000
      • The First Affiliated Hospital of Kunming Medical University
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310000
      • Zhejiang Provincial People's Hospital
    • Hangzhou, Zhejiang, China, 310000
      • Hangzhou First People's Hospital
    • Jiaxing, Zhejiang, China, 314000
      • The First Hospital of Jiaxing
    • Wenzhou, Zhejiang, China, 325000
      • The First Affiliated Hospital of Wenzhou Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Subjects voluntarily participate in this study and have signed informed consent.
2. Male or female subjects between the ages of 18 and 70 (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. Presence of infection or immune-related disease.
3. Subjects with a history of TB or at risk for TB.
4. Received related treatment within the time window specified in the protocol.
5. 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.
6. 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.
7. Pregnant or lactating women, or women who plan to become pregnant during study participation.
8. A history of severe drug allergies.
9. Any other conditions in which the investigator considers it unsuitable for the subject to participate in this study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: ICP-488 Placebo; ICP-488 Placebo will be administered as tablet
Experimental: ICP-488 low dose	Drug: ICP-488 Tablets; ICP-488 will be administered as tablet; Drug: ICP-488 Placebo; ICP-488 Placebo will be administered as tablet
Experimental: ICP-488 high dose	Drug: ICP-488 Tablets; ICP-488 will be administered as tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of subjects who achieved a PASI 75 response (a reduction of minimum 75% from baseline in PASI score) at Week 12.	Proportion of subjects who achieved PASI 75 (PASI score improvement of at least 75% from baseline) at week 12.	Baseline up to Week 12

Collaborators and Investigators

• Sponsor: Beijing InnoCare Pharma Tech Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): January 4, 2024
• Primary Completion (Actual): August 5, 2024
• Study Completion (Actual): September 18, 2024

Study Registration Dates

• First Submitted: October 26, 2023
• First Submitted That Met QC Criteria: October 26, 2023
• First Posted (Actual): October 31, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 26, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases, Papulosquamous; Skin Diseases; Psoriasis
• Other Study ID Numbers: ICP-CL-01002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No