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

Last updated: February 26, 2025
Sponsor: Beijing InnoCare Pharma Tech Co., Ltd.
Overall Status: Completed

Phase

2

Condition

Warts

Rosacea

Skin Wounds

Treatment

ICP-488 Tablets

ICP-488 Placebo

Clinical Study ID

NCT06109818
ICP-CL-01002
  • Ages 18-70
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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) 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. 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 useconcurrently medications, dietary supplements or food with strong CYP1A2 inhibitoryor inductive effect during study participation.

  6. 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.

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

  8. A history of severe drug allergies.

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

Study Design

Total Participants: 129
Treatment Group(s): 2
Primary Treatment: ICP-488 Tablets
Phase: 2
Study Start date:
January 04, 2024
Estimated Completion Date:
September 18, 2024

Connect with a study center

  • The First Affiliated Hospital of Bengbu Medical College

    Bengbu, Anhui 233000
    China

    Site Not Available

  • Beijing Friendship Hospital, Capital Medical University

    Beijing, Beijing 100000
    China

    Site Not Available

  • China-Japan Friendship Hospital

    Beijing, Beijing 100000
    China

    Site Not Available

  • Peking University Third Hospital

    Beijing, Beijing 100000
    China

    Site Not Available

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing 400000
    China

    Site Not Available

  • The First Affiliated Hospital of Fujian Medical University

    Fuzhou, Fujian 350000
    China

    Site Not Available

  • Dermatology Hospital of Southern Medical University

    Guangzhou, Guangdong 510000
    China

    Site Not Available

  • Guangdong Hospital of Traditional Chinese Medicine

    Guangzhou, Guangdong 510120
    China

    Site Not Available

  • Affiliated Hospital of Guizhou Medical University

    Guiyang, Guizhou 550081
    China

    Site Not Available

  • The Affiliated Hospital of Chengde Medical College

    Chengde, Hebei 067032
    China

    Site Not Available

  • The First Affiliated Hospital of Hebei Medical University

    Shijia Zhuang, Hebei 050000
    China

    Site Not Available

  • The first hospital of hebei medical university

    Shijia Zhuang, Hebei 050000
    China

    Site Not Available

  • The Second Affiliated Hospital of Hebei Medical University

    Shijiazhuang, Hebei 050000
    China

    Site Not Available

  • Nanyang city first People's Hospital

    Nanyang, Henan 473000
    China

    Site Not Available

  • Henan Provincial People's Hospital

    Zhengzhou, Henan 450000
    China

    Site Not Available

  • Shiyan City People's Hospital

    Shiyan, Hubei 442000
    China

    Site Not Available

  • Wuhan No.1 hospital

    Wuhan, Hubei 430030
    China

    Site Not Available

  • Wuhan University People's Hospital

    Wuhan, Hubei 430000
    China

    Site Not Available

  • The third xinagya hospital of central south unversity

    Changsha, Hunan 410013
    China

    Site Not Available

  • Xiangya hospital central south university

    Changsha, Hunan 410008
    China

    Site Not Available

  • Inner Mongolia Baotou Steel Hospital

    Baotou, Inner Mongolia Autonomous Region 014000
    China

    Site Not Available

  • Affiliated Hospital of Inner Mongolia Medical University

    Hohhot, Inner Mongolia Autonomous Region 010000
    China

    Site Not Available

  • Changzhou First People's Hospital

    Changzhou, Jiangsu 213000
    China

    Site Not Available

  • Lianyungang First People's Hospital

    Lianyungang, Jiangsu 222000
    China

    Site Not Available

  • Hospital for Skin Diseases, Institute of Dermatology, Chinese Academy of medical Sciences, Peking Union Medical College

    Nanjing, Jiangsu 210042
    China

    Site Not Available

  • Hospital of Dermatology, Chinese Academy of Medical Sciences

    Nanjing, Jiangsu 210000
    China

    Site Not Available

  • First Hospital of Jilin University

    Changchun, Jilin 130000
    China

    Site Not Available

  • Mei he kou central hospital

    Meihekou, Jilin 135099
    China

    Site Not Available

  • General Hospital of Northeast International Hospital

    Shenyang, Liaoning 110623
    China

    Site Not Available

  • Central Hospital affiliated to shandong first medical unversity

    Jinan, Shandong 250013
    China

    Site Not Available

  • Shandong Dermatology Hospital

    Jinan, Shandong 250000
    China

    Site Not Available

  • Huashan Hospital Affiliated to Fudan University

    Shanghai, Shanghai 200040
    China

    Site Not Available

  • Shanghai Dermatology Hospital

    Shanghai, Shanghai 200000
    China

    Site Not Available

  • Second hospital of shaxi medical unversity

    Taiyuan, Shanxi 030001
    China

    Site Not Available

  • The Second affiliated hospital of Xian jiaotong Unversity

    Xi'an, Shanxi 710004
    China

    Site Not Available

  • Chengdu Second People's Hospital

    Chengdu, Sichuan 610000
    China

    Site Not Available

  • Tianjin Academy of Traditional Chinese Medicine affiliated Hospital

    Tianjin, Tianjin 300000
    China

    Site Not Available

  • The First Affiliated Hospital of Kunming Medical University

    Kunming, Yunnan 650000
    China

    Site Not Available

  • Hangzhou First People's Hospital

    Hangzhou, Zhejiang 310000
    China

    Site Not Available

  • Zhejiang Provincial People's Hospital

    Hangzhou, Zhejiang 310000
    China

    Site Not Available

  • Jiaxing second Hospital

    Jiaxing, Zhejiang 314000
    China

    Site Not Available

  • The First Hospital of Jiaxing

    Jiaxing, Zhejiang 314000
    China

    Site Not Available

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang 325000
    China

    Site Not Available

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