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NCT06775860RecruitingPhase 3

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

Source: ClinicalTrials.gov · Last updated 8 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
552 (estimated)
First submitted
25 Dec 2024
Start date
14 Nov 2024
Primary completion date
25 Nov 2026
Lead sponsor
Beijing InnoCare Pharma Tech Co., Ltd.
NCT number
NCT06775860

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 552
  • From 14 Nov 2024 to the primary completion date, 25 Nov 2026
  • 62 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Lack of response or inadequate response to prior treatment with any JAK inhibitor for AD.

Other illness

  • Other active skin diseases or skin infections requiring systemic treatment or would interfere with appropriate assessment of atopic dermatitis lesions.
  • History of any clinically major diseases, with the exception of atopic dermatitis.

Other

  • Pregnant or breastfeeding females.
  • Consideration by the Investigator, for any reason, that the subject is an unsuitable candidate to receive ICP-332 or participate in this study.

Who the study is looking for

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

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (62)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Capital Medical University Affiliated Beijing Chaoyang Hospital
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BeijingChinaRecruiting
Beijing Tongren Hospital, Capital Medical University
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BeijingChinaRecruiting
Beijing Tsinghua Changgung Hospital
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BeijingChinaRecruiting
Peking University First Hospital
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BeijingChinaRecruiting
Capital Medical University Affiliated Beijing Friendship Hospital
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BeijingChinaRecruiting
Peking University Third Hospital
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BeijingChinaRecruiting
The First Hospital of Jilin University
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ChangchunChinaRecruiting
Central South University Xiangya Hospital
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ChangshaChinaRecruiting
The Second Xiangya Hospital of Central South University
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ChangshaChinaRecruiting
Changzhou First People's Hospital
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ChangzhouChinaRecruiting
Affiliated Hospital of Chengde Medical University
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ChengdeChinaRecruiting
Sichuan Provincial People's Hospital
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ChengduChinaRecruiting
Chengdu Second People's Hospital
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ChengduChinaRecruiting
Chongqing Traditional Chinese Medicine Hospital
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ChongqingChinaRecruiting
The First Affiliated Hospital of Chongqing Medical University
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ChongqingChinaRecruiting
The Affiliated Union Hospital of Fujian Medical University
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FuzhouChinaRecruiting
The First Affiliated Hospital of Fujian Medical University
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FuzhouChinaRecruiting
The First Affiliated Hospital of Gannan Medical University
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GanzhouChinaRecruiting
Nanfang Hospital, Southern Medical University
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GuangzhouChinaRecruiting
Zhongshan University Sun Yat-sen Memorial Hospital
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GuangzhouChinaRecruiting
Dermatology Hospital of Southern Medical University
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GuangzhouChinaRecruiting
Affiliated Hospital of Hebei University of Engineering
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HandanChinaRecruiting
Hangzhou First People's Hospital
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HangzhouChinaRecruiting
The Second Affiliated Hospital Zhejiang University School of Medicine
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HangzhouChinaRecruiting
The Third People's Hospital of Hangzhou
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HangzhouChinaRecruiting
The First Affiliated Hospital of Anhui Medical University
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HefeiChinaRecruiting
The Affiliated Hospital of Inner Mongolia Medical University
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HohhotChinaRecruiting
Shandong Provincial Dermatosis Hospital
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JinanChinaRecruiting
Qilu Hospital of Shandong University
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JinanChinaRecruiting
Jingzhou Central Hospital
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JingzhouChinaRecruiting
Jining First People's Hospital
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JiningChinaRecruiting
Affiliated Hospital of Jiujiang University
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JiujiangChinaRecruiting
The First Affiliated Hospital of Kunming Medical University
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KunmingChinaRecruiting
Liuzhou People's Hospital
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LiuzhouChinaRecruiting
The Second Affiliated Hospital of Henan University of Science and Technology
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LuoyangChinaRecruiting
Jiangxi Provincial Dermatology Hospital
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NanchangChinaRecruiting
The First Affiliated Hospital of NanChang University
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NanchangChinaRecruiting
Sir Run Run Hospital, Nanjing Medical University
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NanjingChinaRecruiting
The First Affiliated Hospital of Ningbo University
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NingboChinaRecruiting
The Affiliated Hospital of Qingdao University
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QingdaoChinaRecruiting
Sanmenxia Central Hospital
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SanmenxiaChinaRecruiting
Shanghai First People's Hospital
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ShanghaiChinaRecruiting
Shanghai Tenth People's Hospital
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ShanghaiChinaRecruiting
Shanghai Skin Disease Hospital
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ShanghaiChinaRecruiting
Yuebei People's Hospital
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ShaoguanChinaRecruiting
Zhongyi Northeast International Hospital Co., Ltd.
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ShenyangChinaRecruiting
Shenyang Hospital of Integrated Traditional Chinese and Western Medicine (Shenyang Seventh People's Hospital)
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ShenyangChinaRecruiting
Shenzhen Second People's Hospital
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ShenzhenChinaRecruiting
Second Affiliated Hospital of Hebei Medical University
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ShijiazhuangChinaRecruiting
Affiliated Hospital of Tianjin Academy of Traditional Chinese Medicine
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TianjinChinaRecruiting
General Hospital of Tianjin Medical University
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TianjinChinaRecruiting
The First Affiliated Hospital of Wenzhou Medical University
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WenzhouChinaRecruiting
Wuhan Central Hospital
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WuhanChinaRecruiting
Wuhan Hospital of Traditional Chinese and Western Medicine (Wuhan No.1 Hospital)
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WuhanChinaRecruiting
the Second Affiliated Hospital of Wannan Medical College
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WuhuChinaRecruiting
The Second Affiliated Hospital of Xiamen Medical College
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XiamenChinaRecruiting
Shaanxi provincial people's hospital
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Xi'anChinaRecruiting
The First Affiliated Hospital of Xi'an Jiaotong University
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Xi’anChinaRecruiting
Yancheng First People's Hospital
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YanchengChinaRecruiting
The Fourth Affiliated Hospital, Zhejiang University School of Medicine
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YiwuChinaRecruiting
Yuncheng Central Hospital
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YunchengChinaRecruiting
Henan Provincial People's Hospital
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ZhengzhouChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.