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

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of Oral ICP-488 in Patients With Moderate to Severe Plaque Psoriasis

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.

Study Overview

• Status: Recruiting
• Conditions: Plaque Psoriasis Patients
• Intervention / Treatment: Drug: ICP-488 Tablets; Drug: ICP-488 Placebo

• Study Type: Interventional
• Enrollment (Estimated): 383
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Alexia Lu; Phone Number: 010-66609745; Email: CO_HGRAC@innocarepharma.com

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China, 230022
      • Completed
      • The First Affiliated Hospital of Anhui Medical University
    • Wuhu, Anhui, China, 241000
      • Completed
      • The Second Affiliated Hospital of Wannan Medical College
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100050
      • Completed
      • Beijing Friendship Hospital, Capital Medical University
    • Beijing, Beijing Municipality, China, 100020
      • Completed
      • Beijing Chao-Yang Hospital,Capital Medical University
    • Beijing, Beijing Municipality, China, 100191
      • Completed
      • Peking University Third Hospital
    • Beijing, Beijing Municipality, China, 100730
      • Completed
      • Beijing Tongren Hospital,CMU
  • Chongqing Municipality
    • Chongqing, Chongqing Municipality, China, 400016
      • Completed
      • The First Affiliated Hospital of Chongqing Medical University
    • Chongqing, Chongqing Municipality, China, 400021
      • Completed
      • Chongqing Traditional Chinese Medicine Hospital
  • Fujian
    • Fuzhou, Fujian, China, 350001
      • Completed
      • Fujian Medical University Union Hospital
    • Fuzhou, Fujian, China, 350005
      • Completed
      • The First Affiliated Hospital of Fujian Medical University
  • Guangdong
    • Guangzhou, Guangdong, China, 510091
      • Completed
      • Dermatology Hospital of Southern Medical University
    • Guangzhou, Guangdong, China, 510120
      • Completed
      • Sun Yat-sen Memorial Hospital, Sun Yat-sen University
  • Guangxi
    • Liuchow, Guangxi, China, 545006
      • Completed
      • Liuzhou People's Hospital
  • Guizhou
    • Guiyang, Guizhou, China, 550001
      • Completed
      • The Affiliated Hospital of Guizhou Medical University
  • Hebei
    • Chengde, Hebei, China, 067000
      • Completed
      • Affiliated Hospital of Chengde Medical University
    • Shijiazhuang, Hebei, China, 050000
      • Completed
      • The Second Hospital of Hebei Medical University
  • Heilongjiang
    • Harbin, Heilongjiang, China, 150001
      • Completed
      • The 2nd Affiliated Hospital of Harbin Medical University
  • Henan
    • Luoyang, Henan, China, 471000
      • Completed
      • The Second Affiliated Hospital of Henan University of Science and Technology
    • Nanyang, Henan, China, 473000
      • Completed
      • Nanyang Central Hospital
    • Sanmenxia, Henan, China, 472000
      • Completed
      • Sanmenxia Central Hospital
    • Zhengzhou, Henan, China, 450003
      • Completed
      • Henan Provincial People's Hospital
  • Hubei
    • Jingzhou, Hubei, China, 434020
      • Completed
      • Jingzhou Central Hospital
    • Wuhan, Hubei, China, 430022
      • Completed
      • Wuhan Hospital Of Traditional Chinese and Western Medicine (Wuhan No.1 Hospital)
  • Hunan
    • Changsha, Hunan, China, 410008
      • Completed
      • Xiangya Hospital of Central South University
    • Changsha, Hunan, China, 410011
      • Completed
      • The Second Xiangya Hospital of Central South
  • Jiangsu
    • Changzhou, Jiangsu, China, 213003
      • Completed
      • The First People's Hospital of Changzhou
    • Lianyungang, Jiangsu, China, 222002
      • Completed
      • The First People's Hospital of Lianyungang
    • Nanjing, Jiangsu, China, 210042
      • Completed
      • Hospital for skin diseases,Institute of dermatology chinese academy of medical sciences，peking union medical college
  • Jiangxi
    • Ganzhou, Jiangxi, China, 341000
      • Completed
      • First Affiliated Hospital of Gannan Medical University
    • Nanchang, Jiangxi, China, 330000
      • Completed
      • Dermatology Hospital of Jiangxi Province
  • Jilin
    • Changchun, Jilin, China, 130021
      • Completed
      • The First Hospital of Jilin University
  • Liaoning
    • Shenyang, Liaoning, China, 110000
      • Completed
      • Northeast International Hospital
  • Shandong
    • Jinan, Shandong, China, 250012
      • Completed
      • Qilu Hospital of Shandong University
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200040
      • Completed
      • Huashan Hospital, Fudan University
    • Shanghai, Shanghai Municipality, China, 200443
      • Completed
      • Shanghai Skin Disease Hospital skin Disease of tongji University
  • Shanxi
    • Taiyuan, Shanxi, China, 030009
      • Completed
      • Taiyuan Central Hospital
    • Xi’an, Shanxi, China, 710061
      • Recruiting
      • The First Affiliated Hospital of Xi'an Jiaotong University
      • Contact: kuanhou mou
    • Xi’an, Shanxi, China, 710114
      • Completed
      • The Second Affiliated Hospital of Xi'an Jiaotong University
  • Sichuan
    • Chengdu, Sichuan, China, 610017
      • Completed
      • Chengdu Second People's Hospital
    • Chengdu, Sichuan, China, 610072
      • Completed
      • Sichuan Provincial People's Hospital
  • Tianjin Municipality
    • Tianjin, Tianjin Municipality, China, 300120
      • Completed
      • Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital
  • Yunnan
    • Kunming, Yunnan, China, 650032
      • Completed
      • The First Affiliated Hospital of Kunming Medical University
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310009
      • Completed
      • the Second Affiliated Hospital Zhejiang University School of Medicine
    • Jinhua, Zhejiang, China, 322000
      • Completed
      • The Fourth Affiliated Hospital, Zhejiang University School of Medicine
    • Ningbo, Zhejiang, China, 315000
      • Recruiting
      • The First Affiliated Hospital of Ningbo University
      • Contact: bingjiang lin
    • Wenzhou, Zhejiang, China, 325000
      • Completed
      • 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:

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ICP-488 Tablets	Drug: ICP-488 Tablets; Eligible patients will receive ICP-488 orally as per the protocol
Placebo Comparator: ICP-488 Placebo	Drug: ICP-488 Placebo; Eligible patients will receive ICP-488 Placebo orally as per the protocol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The proportion of subjects who achieve a score of clear (0) or almost clear (1) with an improvement of at least 2 points from baseline on the static Physician's Global Assessment (sPGA) at week 16	week 16
Percentage of subjects who achieved a PASI 75 response (a reduction of minimum 75% from baseline in PASI score) at Week 16	Week 16

Secondary Outcome Measures

Outcome Measure	Time Frame
Adverse events	Week 52
Percentage of subjects with PASI 50/75/90/100 in each planned visit	Week 52
Percentage of subjects with sPGA score of 0 (clear) or 1 (almost clear) and an improvement of at least 2 points from baseline in planned visits.	Week 52
The proportion of subjects with sPGA score of 0 in each planned visit.	Week 52
PK parameter: ICP-488 and its metabolite.	Week 52

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2025
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): February 1, 2027

Study Registration Dates

• First Submitted: February 18, 2025
• First Submitted That Met QC Criteria: February 21, 2025
• First Posted (Actual): February 24, 2025

Study Record Updates

• Last Update Posted (Actual): February 9, 2026
• Last Update Submitted That Met QC Criteria: February 5, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases, Papulosquamous; Skin Diseases; Psoriasis
• Other Study ID Numbers: ICP-CL-01005

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