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

Last updated: April 14, 2025
Sponsor: Beijing InnoCare Pharma Tech Co., Ltd.
Overall Status: Active - Recruiting

Phase

3

Condition

Rash

Warts

Rosacea

Treatment

ICP-488 Placebo

ICP-488 Tablets

Clinical Study ID

NCT06842199
ICP-CL-01005
  • Ages 18-75
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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) atthe 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 physicianoverall assessment (sPGA) ≥3 scores

Exclusion

Exclusion Criteria:

  1. The diagnosis was non-plaque psoriasis.

  2. Subjects with concurrent skin diseases that the investigator believes wouldinterfere 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 useconcurrently medications, dietary supplements or food (e.g., grapefruit orgrapefruit juice) with strong CYP1A2/CYP3A4 inhibitory or inductive effect duringstudy participation.

  7. The investigator has determined that there are clinically significant test resultsand that participation in this trial would pose an unacceptable risk to patients; Orthe laboratory values of the subjects in the screening period meet the criteriaspecified in the protocol.

  8. Pregnant or lactating women, or women who plan to become pregnant during studyparticipation.

  9. A history of severe drug allergies.

  10. Any other conditions in which the investigator considers it unsuitable for thesubject to participate in this study.

Study Design

Total Participants: 360
Treatment Group(s): 2
Primary Treatment: ICP-488 Placebo
Phase: 3
Study Start date:
March 20, 2025
Estimated Completion Date:
February 28, 2027

Connect with a study center

  • The First Affiliated Hospital of Anhui Medical University

    Hefei, Anhui 230022
    China

    Site Not Available

  • The Second Affiliated Hospital of Wannan Medical College

    Wuhu, Anhui 241000
    China

    Site Not Available

  • Beijing Chao-Yang Hospital,Capital Medical University

    Beijing, Beijing 100020
    China

    Site Not Available

  • Beijing Friendship Hospital, Capital Medical University

    Beijing, Beijing 100050
    China

    Site Not Available

  • Beijing Tongren Hospital,CMU

    Beijing, Beijing 100730
    China

    Site Not Available

  • Peking University Third Hospital

    Beijing, Beijing 100191
    China

    Site Not Available

  • Chongqing Traditional Chinese Medicine Hospital

    Chongqing, Chongqing 400021
    China

    Site Not Available

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing 400016
    China

    Site Not Available

  • Fujian Medical University Union Hospital

    Fuzhou, Fujian 350001
    China

    Site Not Available

  • The First Affiliated Hospital of Fujian Medical University

    Fuzhou, Fujian 350005
    China

    Site Not Available

  • Dermatology Hospital of Southern Medical University

    Guangzhou, Guangdong 510091
    China

    Site Not Available

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

    Guangzhou, Guangdong 510120
    China

    Site Not Available

  • The Second Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong 510120
    China

    Site Not Available

  • Liuzhou People's Hospital

    Liuzhou, Guangxi 545006
    China

    Site Not Available

  • The Affiliated Hospital of Guizhou Medical University

    Guiyang, Guizhou 550001
    China

    Site Not Available

  • Affiliated Hospital of Chengde Medical University

    Chengde, Hebei 067000
    China

    Site Not Available

  • Affiliated Hospital of Hebei University of Engineering

    Handan, Hebei 056000
    China

    Site Not Available

  • The Second Hospital of Hebei Medical University

    Shijiazhuang, Hebei 050000
    China

    Site Not Available

  • The 2nd Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang 150001
    China

    Site Not Available

  • The Second Affiliated Hospital of Henan University of Science and technology

    Luoyang, Henan 471000
    China

    Site Not Available

  • Nanyang Central Hospital

    Nanyang, Henan 473000
    China

    Site Not Available

  • Sanmenxia Central Hospital

    Sanmenxia, Henan 472000
    China

    Site Not Available

  • Henan Provincial People's Hospital

    Zhengzhou, Henan 450003
    China

    Site Not Available

  • Jingzhou Central Hospital

    Jingzhou, Hubei 434020
    China

    Site Not Available

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

    Wuhan, Hubei 430022
    China

    Site Not Available

  • Xiangya Hospital of Central South University

    Changsha, Hunan 410008
    China

    Site Not Available

  • The Affiliated Hospital of Inner Mongolia Medical University

    Hohhot, Inner Mongolia 010030
    China

    Site Not Available

  • The First People's Hospital of Changzhou

    Changzhou, Jiangsu 213003
    China

    Site Not Available

  • The First People's Hospital of Lianyungang

    Lianyungang, Jiangsu 222002
    China

    Site Not Available

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

    Nanjing, Jiangsu 210042
    China

    Active - Recruiting

  • First Affiliated Hospital of Gannan Medical University

    Ganzhou, Jiangxi 341000
    China

    Site Not Available

  • Dermatology Hospital of Jiangxi Province

    Nanchang, Jiangxi 330000
    China

    Site Not Available

  • The First Hospital of Jilin University

    Changchun, Jilin 130021
    China

    Site Not Available

  • Northeast International Hospital

    Shenyang, Liaoning 110000
    China

    Site Not Available

  • Qilu Hospital of Shandong University

    Jinan, Shandong 250012
    China

    Site Not Available

  • Shandong First Medical University Affiliated Dermatology Hospital

    Jinan, Shandong 250022
    China

    Site Not Available

  • The Affiliated Hospital of Qingdao University

    Qingdao, Shandong 266000
    China

    Site Not Available

  • Huashan Hospital, Fudan University

    Shanghai, Shanghai 200040
    China

    Site Not Available

  • Shanghai Skin Disease Hospital skin Disease of tongji University

    Shanghai, Shanghai 200443
    China

    Site Not Available

  • Taiyuan Central Hospital

    Taiyuan, Shanxi 030009
    China

    Site Not Available

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, Shanxi 710061
    China

    Site Not Available

  • The Second Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, Shanxi 710114
    China

    Site Not Available

  • Chengdu Second People's Hospital

    Chengdu, Sichuan 610017
    China

    Site Not Available

  • Sichuan Provincial People's Hospital

    Chengdu, Sichuan 610072
    China

    Site Not Available

  • Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital

    Tianjin, Tianjin 300120
    China

    Site Not Available

  • The First Affiliated Hospital of Kunming Medical University

    Kunming, Yunnan 650032
    China

    Site Not Available

  • The Second Affiliated Hospital Zhejiang University School of Medicine

    Hangzhou, Zhejiang 310009
    China

    Site Not Available

  • The Fourth Affiliated Hospital, Zhejiang University School of Medicine

    Jinhua, Zhejiang 322000
    China

    Site Not Available

  • The First Affiliated Hospital Of Ningbo University

    Ningbo, Zhejiang 315000
    China

    Site Not Available

  • The 1st School of Medicine,School of information and Engineering The 1st Affiliated Hospital of WMU

    Wenzhou, Zhejiang 325000
    China

    Site Not Available

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