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.
- Diseases
- Atopic dermatitis (eczema)
- 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
Sites (62)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Capital Medical University Affiliated Beijing Chaoyang Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| Beijing Tongren Hospital, Capital Medical University Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| Beijing Tsinghua Changgung Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| Peking University First Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| Capital Medical University Affiliated Beijing Friendship Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| Peking University Third Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| The First Hospital of Jilin University Coordinator of this site? Confirm its status | Changchun | China | Recruiting |
| Central South University Xiangya Hospital Coordinator of this site? Confirm its status | Changsha | China | Recruiting |
| The Second Xiangya Hospital of Central South University Coordinator of this site? Confirm its status | Changsha | China | Recruiting |
| Changzhou First People's Hospital Coordinator of this site? Confirm its status | Changzhou | China | Recruiting |
| Affiliated Hospital of Chengde Medical University Coordinator of this site? Confirm its status | Chengde | China | Recruiting |
| Sichuan Provincial People's Hospital Coordinator of this site? Confirm its status | Chengdu | China | Recruiting |
| Chengdu Second People's Hospital Coordinator of this site? Confirm its status | Chengdu | China | Recruiting |
| Chongqing Traditional Chinese Medicine Hospital Coordinator of this site? Confirm its status | Chongqing | China | Recruiting |
| The First Affiliated Hospital of Chongqing Medical University Coordinator of this site? Confirm its status | Chongqing | China | Recruiting |
| The Affiliated Union Hospital of Fujian Medical University Coordinator of this site? Confirm its status | Fuzhou | China | Recruiting |
| The First Affiliated Hospital of Fujian Medical University Coordinator of this site? Confirm its status | Fuzhou | China | Recruiting |
| The First Affiliated Hospital of Gannan Medical University Coordinator of this site? Confirm its status | Ganzhou | China | Recruiting |
| Nanfang Hospital, Southern Medical University Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
| Zhongshan University Sun Yat-sen Memorial Hospital Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
| Dermatology Hospital of Southern Medical University Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
| Affiliated Hospital of Hebei University of Engineering Coordinator of this site? Confirm its status | Handan | China | Recruiting |
| Hangzhou First People's Hospital Coordinator of this site? Confirm its status | Hangzhou | China | Recruiting |
| The Second Affiliated Hospital Zhejiang University School of Medicine Coordinator of this site? Confirm its status | Hangzhou | China | Recruiting |
| The Third People's Hospital of Hangzhou Coordinator of this site? Confirm its status | Hangzhou | China | Recruiting |
| The First Affiliated Hospital of Anhui Medical University Coordinator of this site? Confirm its status | Hefei | China | Recruiting |
| The Affiliated Hospital of Inner Mongolia Medical University Coordinator of this site? Confirm its status | Hohhot | China | Recruiting |
| Shandong Provincial Dermatosis Hospital Coordinator of this site? Confirm its status | Jinan | China | Recruiting |
| Qilu Hospital of Shandong University Coordinator of this site? Confirm its status | Jinan | China | Recruiting |
| Jingzhou Central Hospital Coordinator of this site? Confirm its status | Jingzhou | China | Recruiting |
| Jining First People's Hospital Coordinator of this site? Confirm its status | Jining | China | Recruiting |
| Affiliated Hospital of Jiujiang University Coordinator of this site? Confirm its status | Jiujiang | China | Recruiting |
| The First Affiliated Hospital of Kunming Medical University Coordinator of this site? Confirm its status | Kunming | China | Recruiting |
| Liuzhou People's Hospital Coordinator of this site? Confirm its status | Liuzhou | China | Recruiting |
| The Second Affiliated Hospital of Henan University of Science and Technology Coordinator of this site? Confirm its status | Luoyang | China | Recruiting |
| Jiangxi Provincial Dermatology Hospital Coordinator of this site? Confirm its status | Nanchang | China | Recruiting |
| The First Affiliated Hospital of NanChang University Coordinator of this site? Confirm its status | Nanchang | China | Recruiting |
| Sir Run Run Hospital, Nanjing Medical University Coordinator of this site? Confirm its status | Nanjing | China | Recruiting |
| The First Affiliated Hospital of Ningbo University Coordinator of this site? Confirm its status | Ningbo | China | Recruiting |
| The Affiliated Hospital of Qingdao University Coordinator of this site? Confirm its status | Qingdao | China | Recruiting |
| Sanmenxia Central Hospital Coordinator of this site? Confirm its status | Sanmenxia | China | Recruiting |
| Shanghai First People's Hospital Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
| Shanghai Tenth People's Hospital Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
| Shanghai Skin Disease Hospital Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
| Yuebei People's Hospital Coordinator of this site? Confirm its status | Shaoguan | China | Recruiting |
| Zhongyi Northeast International Hospital Co., Ltd. Coordinator of this site? Confirm its status | Shenyang | China | Recruiting |
| Shenyang Hospital of Integrated Traditional Chinese and Western Medicine (Shenyang Seventh People's Hospital) Coordinator of this site? Confirm its status | Shenyang | China | Recruiting |
| Shenzhen Second People's Hospital Coordinator of this site? Confirm its status | Shenzhen | China | Recruiting |
| Second Affiliated Hospital of Hebei Medical University Coordinator of this site? Confirm its status | Shijiazhuang | China | Recruiting |
| Affiliated Hospital of Tianjin Academy of Traditional Chinese Medicine Coordinator of this site? Confirm its status | Tianjin | China | Recruiting |
| General Hospital of Tianjin Medical University Coordinator of this site? Confirm its status | Tianjin | China | Recruiting |
| The First Affiliated Hospital of Wenzhou Medical University Coordinator of this site? Confirm its status | Wenzhou | China | Recruiting |
| Wuhan Central Hospital Coordinator of this site? Confirm its status | Wuhan | China | Recruiting |
| Wuhan Hospital of Traditional Chinese and Western Medicine (Wuhan No.1 Hospital) Coordinator of this site? Confirm its status | Wuhan | China | Recruiting |
| the Second Affiliated Hospital of Wannan Medical College Coordinator of this site? Confirm its status | Wuhu | China | Recruiting |
| The Second Affiliated Hospital of Xiamen Medical College Coordinator of this site? Confirm its status | Xiamen | China | Recruiting |
| Shaanxi provincial people's hospital Coordinator of this site? Confirm its status | Xi'an | China | Recruiting |
| The First Affiliated Hospital of Xi'an Jiaotong University Coordinator of this site? Confirm its status | Xi’an | China | Recruiting |
| Yancheng First People's Hospital Coordinator of this site? Confirm its status | Yancheng | China | Recruiting |
| The Fourth Affiliated Hospital, Zhejiang University School of Medicine Coordinator of this site? Confirm its status | Yiwu | China | Recruiting |
| Yuncheng Central Hospital Coordinator of this site? Confirm its status | Yuncheng | China | Recruiting |
| Henan Provincial People's Hospital Coordinator of this site? Confirm its status | Zhengzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.