ICP-332 in Subjects With Moderate to Severe Atopic Dermatitis

September 2, 2025 updated by: Beijing InnoCare Pharma Tech Co., Ltd.

A Randomized, Double-blind, Placebo-controlled Phase III Study Evaluating the Efficacy and Safety of Oral ICP-332 in Subjects With Moderate to Severe Atopic Dermatitis

A randomized, double-blind, placebo-controlled phase III study evaluating the efficacy and safety of oral ICP-332 in subjects with moderate to severe atopic dermatitis

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

552

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Anhui
      • Hefei, Anhui, China, 230022
        • Recruiting
        • The First Affiliated Hospital of Anhui Medical University
        • Contact:
          • Zaixing Wang
      • Wuhu, Anhui, China, 241000
        • Recruiting
        • The Second Affiliated Hospital of Wannan Medical College
        • Contact:
          • Ruzhi Zhang
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 102218
        • Recruiting
        • Beijing Tsinghua Changgung Hospital
        • Contact:
          • Yi Zhao
      • Beijing, Beijing Municipality, China, 100191
        • Recruiting
        • Peking University Third Hospital
        • Contact:
          • Chunlei Zhang
      • Beijing, Beijing Municipality, China, 100034
        • Recruiting
        • Peking University First Hospital
        • Contact:
          • Hang Li
      • Beijing, Beijing Municipality, China, 100730
        • Recruiting
        • Beijing Tongren Hospital, Capital Medical University
        • Contact:
          • Aihua Wei
      • Beijing, Beijing Municipality, China, 100050
        • Recruiting
        • Capital Medical University Affiliated Beijing Friendship Hospital
        • Contact:
          • Linfeng Li
      • Beijing, Beijing Municipality, China, 100020
        • Recruiting
        • Capital Medical University Affiliated Beijing Chaoyang Hospital
        • Contact:
          • Fang Liu
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, China, 400016
        • Recruiting
        • The First Affiliated Hospital of Chongqing Medical University
        • Contact:
          • Aijun Chen
      • Chongqing, Chongqing Municipality, China, 400021
        • Recruiting
        • Chongqing Traditional Chinese Medicine Hospital
        • Contact:
          • Qingchun Diao
    • Fujian
      • Fuzhou, Fujian, China, 350005
        • Recruiting
        • The First Affiliated Hospital of Fujian Medical University
        • Contact:
          • Chao Ji
      • Fuzhou, Fujian, China, 350001
        • Recruiting
        • The Affiliated Union Hospital of Fujian Medical University
        • Contact:
          • Huichun Su
      • Xiamen, Fujian, China, 361021
        • Recruiting
        • The Second Affiliated Hospital of Xiamen Medical College
        • Contact:
          • Mingkai Ji
    • Guangdong
      • Guangzhou, Guangdong, China, 510091
        • Recruiting
        • Dermatology Hospital of Southern Medical University
        • Contact:
          • Yunsheng Liang
      • Guangzhou, Guangdong, China, 510515
        • Recruiting
        • Nanfang Hospital, Southern Medical University
        • Contact:
          • Yue Zheng
      • Guangzhou, Guangdong, China, 510120
        • Recruiting
        • Zhongshan University Sun Yat-sen Memorial Hospital
        • Contact:
          • Liangchun Wang
      • Shaoguan, Guangdong, China, 512026
        • Recruiting
        • Yuebei People's Hospital
        • Contact:
          • Weiquan Li
      • Shenzhen, Guangdong, China, 518035
        • Recruiting
        • Shenzhen Second People's Hospital
        • Contact:
          • Wenzhong Wu
    • Guangxi
      • Liuzhou, Guangxi, China, 545006
        • Recruiting
        • Liuzhou people's Hospital
        • Contact:
          • Min Xiao
    • Hebei
      • Chengde, Hebei, China, 067000
        • Recruiting
        • Affiliated Hospital of Chengde Medical University
        • Contact:
          • Xinsuo Duan
      • Handan, Hebei, China, 056002
        • Recruiting
        • Affiliated Hospital of Hebei University of Engineering
        • Contact:
          • Guoying Miao
      • Shijiazhuang, Hebei, China, 050000
        • Recruiting
        • Second Affiliated Hospital of Hebei Medical University
        • Contact:
          • Yanling Li
    • Henan
      • Luoyang, Henan, China, 471000
        • Recruiting
        • The Second Affiliated Hospital of Henan University of Science and Technology
        • Contact:
          • Lin Chen
      • Sanmenxia, Henan, China, 472000
        • Recruiting
        • Sanmenxia Central Hospital
        • Contact:
          • Danhong Jiao
      • Zhengzhou, Henan, China, 450003
        • Recruiting
        • Henan Provincial People's Hospital
        • Contact:
          • Jianguo Li
    • Hubei
      • Jingzhou, Hubei, China, 434020
        • Recruiting
        • Jingzhou Central Hospital
        • Contact:
          • Yi Sun
      • Wuhan, Hubei, China, 430014
        • Recruiting
        • Wuhan Central Hospital
        • Contact:
          • Ying Gao
      • Wuhan, Hubei, China, 430022
        • Recruiting
        • Wuhan Hospital Of Traditional Chinese and Western Medicine (Wuhan No.1 Hospital)
        • Contact:
          • Liuqing Chen
    • Hunan
      • Changsha, Hunan, China, 410011
        • Recruiting
        • The second Xiangya hospital of central south university
        • Contact:
          • Rong Xiao
      • Changsha, Hunan, China, 410008
        • Recruiting
        • Central South University Xiangya Hospital
        • Contact:
          • Juan Su
    • Inner Mongolia
      • Hohhot, Inner Mongolia, China, 010050
        • Recruiting
        • The Affiliated Hospital of Inner Mongolia Medical University
        • Contact:
          • Xinxiang Lv
    • Jiangsu
      • Changzhou, Jiangsu, China, 213003
        • Recruiting
        • Changzhou First People's Hospital
        • Contact:
          • Yanxia Yuan
      • Nanjing, Jiangsu, China, 211166
        • Recruiting
        • Sir Run Run Hospital, Nanjing Medical University
        • Contact:
          • Bin Chen
      • Yancheng, Jiangsu, China, 224001
        • Recruiting
        • Yancheng First People's Hospital
        • Contact:
          • Pingping Qin
    • Jiangxi
      • Ganzhou, Jiangxi, China, 341000
        • Recruiting
        • The First Affiliated Hospital of Gannan Medical University
        • Contact:
          • Jingfa Lu
      • Jiujiang, Jiangxi, China, 332000
        • Recruiting
        • Affiliated Hospital of Jiujiang University
        • Contact:
          • Qiuhe Song
      • Nanchang, Jiangxi, China, 330006
        • Recruiting
        • The First Affiliated Hospital of NanChang University
        • Contact:
          • Xianwei Cao
      • Nanchang, Jiangxi, China, 330001
        • Recruiting
        • Jiangxi Provincial Dermatology Hospital
        • Contact:
          • Guohong Hu
    • Jilin
      • Changchun, Jilin, China, 130021
        • Recruiting
        • The First Hospital of Jilin University
        • Contact:
          • Shanshan Li
    • Liaoning
      • Shenyang, Liaoning, China, 110001
        • Recruiting
        • Shenyang Hospital of Integrated Traditional Chinese and Western Medicine （Shenyang Seventh People's Hospital）
        • Contact:
          • Yan Liu
      • Shenyang, Liaoning, China, 110179
        • Recruiting
        • Zhongyi Northeast International Hospital Co., Ltd.
        • Contact:
          • Shifa Zhang
    • Shaanxi
      • Xi'an, Shaanxi, China, 710061
        • Recruiting
        • The First Affiliated Hospital of Xi'an Jiaotong University
        • Contact:
          • Yan Zheng
      • Xi'an, Shaanxi, China, 710068
        • Recruiting
        • Shaanxi Provincial People's Hospital
        • Contact:
          • Li Yang
    • Shandong
      • Jinan, Shandong, China, 250012
        • Recruiting
        • Qilu Hospital of Shandong University
        • Contact:
          • Ying Li
      • Jinan, Shandong, China, 250022
        • Recruiting
        • Shandong Provincial Dermatosis Hospital
        • Contact:
          • Furen Zhang
      • Jining, Shandong, China, 272011
        • Recruiting
        • Jining First People's Hospital
        • Contact:
          • Dongmei Shi
      • Qingdao, Shandong, China, 266003
        • Recruiting
        • The Affiliated Hospital of Qingdao University
        • Contact:
          • Guanzhi Chen
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200443
        • Recruiting
        • Shanghai skin disease hospital
        • Contact:
          • Yangfeng Ding
      • Shanghai, Shanghai Municipality, China, 200072
        • Recruiting
        • Shanghai Tenth People's Hospital
        • Contact:
          • Jun Gu
      • Shanghai, Shanghai Municipality, China, 200080
        • Recruiting
        • Shanghai First People's Hospital
        • Contact:
          • Zhouwei Wu
    • Shanxi
      • Yuncheng, Shanxi, China, 440000
        • Recruiting
        • Yuncheng Central Hospital
        • Contact:
          • Juanli Fan
    • Sichuan
      • Chengdu, Sichuan, China, 610072
        • Recruiting
        • Sichuan Provincial People's Hospital
        • Contact:
          • Lixia Zhang
      • Chengdu, Sichuan, China, 610017
        • Recruiting
        • Chengdu Second People's Hospital
        • Contact:
          • Yanyan Feng
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China, 300052
        • Recruiting
        • General Hospital of Tianjin Medical University
        • Contact:
          • Huiping Wang
      • Tianjin, Tianjin Municipality, China, 300120
        • Recruiting
        • Affiliated Hospital of Tianjin Academy of Traditional Chinese Medicine
        • Contact:
          • Litao Zhang
    • Yunnan
      • Kunming, Yunnan, China, 650032
        • Recruiting
        • The First Affiliated Hospital of Kunming Medical University
        • Contact:
          • Weijia Zhao
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310006
        • Recruiting
        • Hangzhou First People's Hospital
        • Contact:
          • Liming Wu
      • Hangzhou, Zhejiang, China, 310009
        • Recruiting
        • The Second Affiliated Hospital, Zhejiang University School of Medicine
        • Contact:
          • Xiaoyong Man
      • Hangzhou, Zhejiang, China, 310009
        • Recruiting
        • The Third People's Hospital of Hangzhou
        • Contact:
          • Aie Xu
      • Ningbo, Zhejiang, China, 315010
        • Recruiting
        • The First Affiliated Hospital of Ningbo University
        • Contact:
          • bingjiang lin
      • Wenzhou, Zhejiang, China, 325000
        • Recruiting
        • The First Affiliated Hospital of Wenzhou Medical University
        • Contact:
          • Zhiming Li
      • Yiwu, Zhejiang, China, 322000
        • Recruiting
        • The Fourth Affiliated Hospital, Zhejiang University School of Medicine
        • Contact:
          • Lunfei Liu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Male or female subjects between 18 and 75 years of age.
  2. Clinical diagnosis of chronic atopic dermatitis (also known as atopic eczema) for at least 1 year
  3. Documented recent history of inadequate response to TCS or TCI, or for whom topical treatments are otherwise medically inadvisable.

  4. Subjects must meet the following criteria for disease activity:

    • Eczema Area and Severity Index (EASI) score ≥ 16 ;
    • (Body Surface Area )BSA affected by AD ≥ 10% ;
    • (validated Investigator's Global Assessment-AD)vIGA-AD score ≥3 ;
    • Baseline weekly average of daily Worst Pruritus NRS ≥ 4.
  5. Women of childbearing potential (WOCBP) and Men must agree

5. Women of childbearing potential (WOCBP) and Men must agree to contraception. 6. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

Exclusion Criteria:

  1. Lack of response or inadequate response to prior treatment with any JAK inhibitor for AD.
  2. Other active skin diseases or skin infections requiring systemic treatment or would interfere with appropriate assessment of atopic dermatitis lesions.
  3. Pregnant or breastfeeding females.
  4. History of any clinically major diseases, with the exception of atopic dermatitis.
  5. Consideration by the Investigator, for any reason, that the subject is an unsuitable candidate to receive ICP-332 or participate in this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: ICP-332 Placebo Tablets
ICP-332 Placebo will be administered as tablet
Experimental: ICP-332
Drug: ICP-332 Tablets
ICP-332 will be administered as tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of subjects achieving at least a 75% reduction in Eczema Area and Severity Index (EASI 75) from Baseline
Time Frame: 16 weeks
16 weeks
Proportion of subjects achieving Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) of 0 or 1 with at least two grades of reduction from Baseline
Time Frame: 16 weeks
16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing InnoCare Pharma Tech Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 14, 2024

Primary Completion (Estimated)

November 25, 2026

Study Completion (Estimated)

December 25, 2026

Study Registration Dates

First Submitted

December 25, 2024

First Submitted That Met QC Criteria

January 9, 2025

First Posted (Actual)

January 15, 2025

Study Record Updates

Last Update Posted (Estimated)

September 8, 2025

Last Update Submitted That Met QC Criteria

September 2, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ICP-CL-00604

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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