Study of the Efficacy and Safety of ICP-332 in Participants With Prurigo Nodularis

Last updated: April 8, 2026
Sponsor: Beijing InnoCare Pharma Tech Co., Ltd.
Overall Status: Active - Recruiting

Phase

2

Condition

N/A

Treatment

Placebo

ICP-322

Clinical Study ID

NCT07236099
ICP-CL-00609
  • Ages 18-75
  • All Genders

Study Summary

Evaluate the efficacy and safety of ICP-332 in participants with Prurigo Nodularis (PN)

Eligibility Criteria

Inclusion

Inclusion Criteria :

  1. Voluntarily sign informed consent forms before any investigational procedure(s) areperformed.

  2. Male or female aged between 18 and 75 years at the time of signing the informedconsent.

  3. Clinical diagnosis of PN by a dermatologist for at least 3 months before theScreening visit.

  4. At least 20 pruriginous lesions on the entire body with a bilateral distribution (onboth legs, and/or both arms and/or trunk) at both screening and the baseline (Day 1)visits.

  5. PP NRS score ≥ 7 at both screening and the baseline (Day 1) visits.

  6. IGA-CPG-S score ≥ 3 at both the screening and the baseline (Day 1) visits.

  7. History of inadequate response to topical corticosteroid of medium or higher potencyor for whom topical treatments are otherwise medically inadvisable (e.g., because ofimportant side effects or safety risks).

Willingness to avoid pregnancy or fathering children

Exclusion

Exclusion Criteria:

  1. Patients with a documented AD severity moderate to severe presence of skinmorbidities other than PN and mild AD that may interfere with the assessment of thestudy outcomes. PN secondary to medications .

  2. Any uncontrolled or serious disease, or any medical, psychological, or surgicalcondition including relevant laboratory abnormalities at screening that may eitherinterfere with the interpretation of the clinical trial results and/or, in theinvestigator's judgment, would adversely affect the patient's participation in thestudy. Active chronic or acute infection participant not suitable for participation,whatever the reason, as judged by the Investigator, including medical or clinicalconditions, or participants potentially at risk of noncompliance to studyprocedures.

Study Design

Total Participants: 135
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
November 27, 2025
Estimated Completion Date:
October 31, 2027

Connect with a study center

  • The Second Affiliated Hospital of Wannan Medical College

    Wuhu, Anhui 241000
    China

    Active - Recruiting

  • The Second Affiliated Hospital of Wannan Medical College

    Wuhu 1791236, Anhui 1818058 241000
    China

    Site Not Available

  • Peking University People's Hospital

    Beijing, Beijing Municipality 100044
    China

    Active - Recruiting

  • Peking University People's Hospital

    Beijing 1816670, Beijing Municipality 2038349 100044
    China

    Site Not Available

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality 400016
    China

    Active - Recruiting

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing 1814906, Chongqing Municipality 1814905 400016
    China

    Site Not Available

  • The First Affiliated Hospital of Fujian Medical University

    Fuzhou, Fujian 350005
    China

    Active - Recruiting

  • The First Affiliated Hospital of Fujian Medical University

    Fuzhou 1810821, Fujian 1811017 350005
    China

    Site Not Available

  • Dermatology Hospital of Southern Medical University

    Guangzhou, Guangdong 510091
    China

    Active - Recruiting

  • Dermatology Hospital of Southern Medical University

    Guangzhou 1809858, Guangdong 1809935 510091
    China

    Site Not Available

  • The First Hospital of Hebei Medical University

    Shijiazhuang, Hebei 050000
    China

    Active - Recruiting

  • The First Hospital of Hebei Medical University

    Shijiazhuang 1795270, Hebei 1808773 050000
    China

    Site Not Available

  • Jingzhou Central Hospital

    Jingzhou, Hubei 434020
    China

    Active - Recruiting

  • Jingzhou Central Hospital

    Jingzhou 1805540, Hubei 1806949 434020
    China

    Site Not Available

  • Xiangya Hospital of Central South University

    Changsha, Hunan 410008
    China

    Active - Recruiting

  • Xiangya Hospital of Central South University

    Changsha 1815577, Hunan 1806691 410008
    China

    Site Not Available

  • The first hospital of Jilin University

    Changchun, Jilin 130021
    China

    Active - Recruiting

  • The first hospital of Jilin University

    Changchun 2038180, Jilin 2036500 130021
    China

    Site Not Available

  • Shenyang Seventh People's Hospital

    Shenyang, Liaoning 110003
    China

    Active - Recruiting

  • Shenyang Seventh People's Hospital

    Shenyang 2034937, Liaoning 2036115 110003
    China

    Site Not Available

  • Shandong Provincial Dermatology Hospital

    Jinan, Shandong 250022
    China

    Active - Recruiting

  • Shandong Provincial Dermatology Hospital

    Jinan 1805753, Shandong 1796328 250022
    China

    Site Not Available

  • Chengdu Second People's Hospital

    Chengdu, Sichuan 610021
    China

    Active - Recruiting

  • Sichuan Provincial People's Hospital

    Chengdu, Sichuan 610072
    China

    Active - Recruiting

  • Chengdu Second People's Hospital

    Chengdu 1815286, Sichuan 1794299 610021
    China

    Site Not Available

  • Sichuan Provincial People's Hospital

    Chengdu 1815286, Sichuan 1794299 610072
    China

    Site Not Available

  • Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital

    Tianjin, Tianjin Municipality 300131
    China

    Active - Recruiting

  • Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital

    Tianjin 1792947, Tianjin Municipality 1792943 300131
    China

    Site Not Available

  • Affiliated Hangzhou First People's Hospital,School of Medicine ,Westlake University

    Hangzhou, Zhejiang 250022
    China

    Active - Recruiting

  • Affiliated Hangzhou First People's Hospital,School of Medicine ,Westlake University

    Hangzhou 1808926, Zhejiang 1784764 250022
    China

    Site Not Available

  • Apex Clinical Research Center

    Mayfield Heights, Ohio 44124
    United States

    Active - Recruiting

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