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The investigator, the subject, and the sponsor's project team will remain blind throughout the study. Subjects will be randomly assigned to one of the three treatment groups at a ratio of 1:1:1 to be given the drug once a day for 4 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High-dose | Experimental | 40 mg ICP-332 tablet 3 tablets, once a day |
|
| Low-dose | Experimental | 40 mg ICP-332 2 tablets + 1 placebo tablet once daily |
|
| Blank control | Placebo Comparator | Placebo 3 tablets once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ICP-332 | Drug | Tablet, 40 mg |
| |
| ICP-332 Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events (AEs) | Up to 24 weeks | |
| Systolic and Diastolic Blood Pressure | Up to 24 weeks | |
| Pulse Rate | Up to 24 weeks | |
| Electrocardiogram (ECG) QT Interval | Up to 24 weeks | |
| Number of participants with treatmentrelated adverse events as assessed by CTCAE v4.0 | Up to 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage change of EASI score from baseline in week 4 | 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pengcheng Lei | Contact | +86 18501252185 | pengcheng.lei@innocarepharma.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Hospital | Not yet recruiting | Beijing | Beijing Municipality | 100006 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41533373 | Derived | Xu J, Zhang L, Liang Y, Ji C, Xu A, Li Z, Li L, Lei T, Zhang C, Chen R, Tao X, Zhang R, Fang H, Zheng J, Yang W, Zhang G, Duan X, Ding Y, Yin W, Zhou W, Fan D, Du Y. Safety and Efficacy of ICP-332 for Moderate to Severe Atopic Dermatitis: A Phase 2 Randomized Clinical Trial. JAMA Dermatol. 2026 Mar 1;162(3):227-235. doi: 10.1001/jamadermatol.2025.5295. |
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| Drug |
Tablets, in appearance, size, color, dosage form, packaging, instructions, labels and other aspects of the corresponding specifications of ICP-332. |
|
| Beijing Friendship Hospital, Capital Medical University | Recruiting | Beijing | Beijing Municipality | 100050 | China |
|
| Peking University Third Hospital | Recruiting | Beijing | Beijing Municipality | 100191 | China |
|
| Second Hospital of the Army Medical University | Not yet recruiting | Chongqing | Chongqing Municipality | 400037 | China |
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| The First Affiliated Hospital of Fujian Medical University | Recruiting | Fuzhou | Fujian | 350004 | China |
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| Dermatology Hospital of Southern Medical University | Recruiting | Guangzhou | Guangdong | 510091 | China |
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| The Second Affiliated Hospital of Guangzhou Medical University | Recruiting | Guangzhou | Guangdong | 510260 | China |
|
| The Affiliated Hospital of Chengde Medical College | Recruiting | Chengde | Hebei | 067020 | China |
|
| The First Hospital of Hebei Medical University | Recruiting | Shijiazhuang | Hebei | 050023 | China |
|
| Nanyang First People's Hospital | Recruiting | Nanyang | Henan | 473004 | China |
|
| Shiyan City People's Hospital | Recruiting | Shiyan | Hubei | 442099 | China |
|
| Wuhan University People's Hospital | Recruiting | Wuhan | Hubei | 430060 | China |
|
| Changzhou First People's Hospital | Recruiting | Changzhou | Jiangsu | 213004 | China |
|
| Wuxi Second People's Hospital | Recruiting | Wuxi | Jiangsu | 214001 | China |
|
| Affiliated Hospital of Jiangsu University | Recruiting | Zhenjiang | Jiangsu | 210031 | China |
|
| The First Affiliated Hospital of China Medical University | Recruiting | Shenyang | Liaoning | 110002 | China |
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| Ruijin Hospital, Shanghai Jiao Tong University School of Medicine | Recruiting | Shanghai | Shanghai Municipality | 200025 | China |
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| Shanghai Dermatology Hospital | Recruiting | Shanghai | Shanghai Municipality | 220443 | China |
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| Huashan Hospital Affiliated to Fudan University | Recruiting | Shanghai | Shanghai Municipality | China |
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| The Second Hospital of Shanxi Medical University | Not yet recruiting | Taiyuan | Shanxi | 030001 | China |
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| Suining Central Hospital | Recruiting | Suining | Sichuan | 629099 | China |
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| Affiliated Hospital of Tianjin Academy of Traditional Chinese Medicine | Recruiting | Tianjin | Tianjin Municipality | 300120 | China |
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| The Second Affiliated Hospital of Kunming Medical University | Not yet recruiting | Kunming | Yunnan | 650106 | China |
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| The First Affiliated Hospital of Zhejiang University School of Medicine | Recruiting | Hangzhou | Zhejiang | 310003 | China |
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| Hangzhou Third People's Hospital | Recruiting | Hangzhou | Zhejiang | 310009 | China |
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| Zhejiang Provincial People's Hospital | Not yet recruiting | Hangzhou | Zhejiang | 314408 | China |
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| Jiaxing First Hospital | Recruiting | Jiaxing | Zhejiang | 314001 | China |
|
| The First Affiliated Hospital of Wenzhou Medical University | Not yet recruiting | Wenzhou | Zhejiang | 325015 | China |
|