Actively Recruiting

Phase 3
Age: 18Years - 75Years
All Genders
NCT06842199

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

Led by Beijing InnoCare Pharma Tech Co., Ltd. · Updated on 2026-02-09

383

Participants Needed

46

Research Sites

97 weeks

Total Duration

On this page

AI-Summary

What this Trial Is 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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Voluntarily agree to participate and sign informed consent
  • Male or female aged 18 to 75 years
  • History of plaque psoriasis for at least 6 months
  • Currently receiving systemic therapy and/or phototherapy
  • Psoriasis Area and Severity Index (PASI) score of 12 or higher
  • Psoriasis affecting 10% or more of body surface area
  • Static Physician Global Assessment (sPGA) score of 3 or higher
Not Eligible

You will not qualify if you...

  • Diagnosis of non-plaque psoriasis
  • Other skin diseases that interfere with study assessments
  • Presence of infection or immune-related diseases
  • History of tuberculosis or at risk for tuberculosis
  • Recent related treatment within protocol-defined time windows
  • Use of strong CYP1A2/CYP3A4 inhibitors or inducers within 28 days or less than 5 half-lives
  • Clinically significant lab abnormalities or test results posing risk
  • Pregnant, lactating, or planning pregnancy during the study
  • History of severe drug allergies
  • Any other condition deemed unsuitable by the investigator for participation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 46 locations

1

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China, 230022

Completed

2

The Second Affiliated Hospital of Wannan Medical College

Wuhu, Anhui, China, 241000

Completed

3

Beijing Chao-Yang Hospital,Capital Medical University

Beijing, Beijing Municipality, China, 100020

Completed

4

Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, China, 100050

Completed

5

Peking University Third Hospital

Beijing, Beijing Municipality, China, 100191

Completed

6

Beijing Tongren Hospital,CMU

Beijing, Beijing Municipality, China, 100730

Completed

7

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China, 400016

Completed

8

Chongqing Traditional Chinese Medicine Hospital

Chongqing, Chongqing Municipality, China, 400021

Completed

9

Fujian Medical University Union Hospital

Fuzhou, Fujian, China, 350001

Completed

10

The First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, China, 350005

Completed

11

Dermatology Hospital of Southern Medical University

Guangzhou, Guangdong, China, 510091

Completed

12

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China, 510120

Completed

13

Liuzhou People's Hospital

Liuzhou, Guangxi, China, 545006

Completed

14

The Affiliated Hospital of Guizhou Medical University

Guiyang, Guizhou, China, 550001

Completed

15

Affiliated Hospital of Chengde Medical University

Chengde, Hebei, China, 067000

Completed

16

The Second Hospital of Hebei Medical University

Shijiazhuang, Hebei, China, 050000

Completed

17

The 2nd Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, China, 150001

Completed

18

The Second Affiliated Hospital of Henan University of Science and technology

Luoyang, Henan, China, 471000

Completed

19

Nanyang Central Hospital

Nanyang, Henan, China, 473000

Completed

20

Sanmenxia Central Hospital

Sanmenxia, Henan, China, 472000

Completed

21

Henan Provincial People's Hospital

Zhengzhou, Henan, China, 450003

Completed

22

Jingzhou Central Hospital

Jingzhou, Hubei, China, 434020

Completed

23

Wuhan Hospital Of Traditional Chinese and Western Medicine (Wuhan No.1 Hospital)

Wuhan, Hubei, China, 430022

Completed

24

Xiangya Hospital of Central South University

Changsha, Hunan, China, 410008

Completed

25

The Second Xiangya Hospital of Central South

Changsha, Hunan, China, 410011

Completed

26

The First People's Hospital of Changzhou

Changzhou, Jiangsu, China, 213003

Completed

27

The First People's Hospital of Lianyungang

Lianyungang, Jiangsu, China, 222002

Completed

28

Hospital for skin diseases,Institute of dermatology chinese academy of medical sciences,peking union medical college

Nanjing, Jiangsu, China, 210042

Completed

29

First Affiliated Hospital of Gannan Medical University

Ganzhou, Jiangxi, China, 341000

Completed

30

Dermatology Hospital of Jiangxi Province

Nanchang, Jiangxi, China, 330000

Completed

31

The First Hospital of Jilin University

Changchun, Jilin, China, 130021

Completed

32

Northeast International Hospital

Shenyang, Liaoning, China, 110000

Completed

33

Qilu Hospital of Shandong University

Jinan, Shandong, China, 250012

Completed

34

Huashan Hospital, Fudan University

Shanghai, Shanghai Municipality, China, 200040

Completed

35

Shanghai Skin Disease Hospital skin Disease of tongji University

Shanghai, Shanghai Municipality, China, 200443

Completed

36

Taiyuan Central Hospital

Taiyuan, Shanxi, China, 030009

Completed

37

The First Affiliated Hospital of Xi'an Jiaotong University

Xi’an, Shanxi, China, 710061

Actively Recruiting

38

The Second Affiliated Hospital of Xi'an Jiaotong University

Xi’an, Shanxi, China, 710114

Completed

39

Chengdu Second People's Hospital

Chengdu, Sichuan, China, 610017

Completed

40

Sichuan Provincial People's Hospital

Chengdu, Sichuan, China, 610072

Completed

41

Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital

Tianjin, Tianjin Municipality, China, 300120

Completed

42

The First Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, China, 650032

Completed

43

The Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, China, 310009

Completed

44

The Fourth Affiliated Hospital, Zhejiang University School of Medicine

Jinhua, Zhejiang, China, 322000

Completed

45

The First Affiliated Hospital Of Ningbo University

Ningbo, Zhejiang, China, 315000

Actively Recruiting

46

The first Affiliated hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China, 325000

Completed

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Research Team

A

Alexia Lu

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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