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This is a multicenter, open label phase II clinical study to evaluate the efficacy and safety of AK120 in the treatment of subjects with moderate to severe atopic dermatitis.
This is a multicenter, open label phase II clinical study to evaluate the efficacy and safety of AK120 in the treatment of subjects with moderate to severe atopic dermatitis. The total duration of the study (including screening period, treatment period and follow-up period) planned for each subject is approximately 25 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AK120 300mg Q2W(Double the initial dose) | Experimental | AK120 600mg (first day) then 300mg Q2W SC until week 14. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AK120 300mg Q2W (JAK inhibitor users need to double the initial dose) | Drug | AK120 300mg Q2W SC until week 14(JAK inhibitor users need to receive a first dose of 600mg SC) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of treatment emergent adverse events (TEAEs) | An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product temporally associated with the use of study treatment, whether or not considered related to the study treatment | through study completion, an average of 25 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Eczema Area and Severity Index (EASI) score | Percentage change in EASI score from baseline. EASI score is to assesses the extent and severity of eczema in four body regions with the score ranges from 0 to 72. The higher the score, the more severe the eczema. | baseline to week 20 |
| Investigator's Global Assessment (IGA) 0/1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Luhe Hospital Affiliated to Capital Medical University | Beijing | Beijing Municipality | China | |||
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Percentage of subjects who achieved 0/1 in the IGA. The IGA is an assessment instrument used in clinical studies to rate the severity of atopic dermatitis globally, based on a 5-point scale ranging from 0 (clear) to 4 (severe). |
| from baseline to week 20 |
| Affected body surface area (BSA) score | Percentage change in BSA score from baseline. Body surface area affected by atopic dermatitis will be assessed for each section of the body (0-100%) and will be reported as a percentage of all major body sections combined. | from baseline to week 20 |
| Area under the curve(AUC) of AK120 | Assessment of AUC of AK120. | before drug administration at week 0/4/8/12/16 |
| Anti-drug antibodies (ADA) of AK120 | Percentage of subjects with detectable anti drug antibodies (ADA) of AK120. | before drug administration at week 0/4/8/16/20 |
| Peking University Third Hospital |
| Beijing |
| Beijing Municipality |
| China |
| Xiyuan Hospital of CACMS | Beijing | Beijing Municipality | China |
| The First Affiliated Hospital of Fujian Medical University | Fuzhou | Fujian | China |
| The Second Affiliated Hospital of Xiamen Medical College | Xiamen | Fujian | China |
| The Second Hospital & Clinical Medical School, Lanzhou University | Lanzhou | Gansu | China |
| Guangdong Provincial Dermatology Hospital | Guangzhou | Guangdong | China |
| Guangdong Provincial People's Hospital | Guangzhou | Guangdong | China |
| Second people's Hospital of Shenzhen | Shenzhen | Guangdong | China |
| Shenzhen Hospital of University of Hong Kong | Shenzhen | Guangdong | China |
| Liuzhou People's Hospital | Liuzhou | Guangxi | China |
| Cangzhou People's Hospital | Cangzhou | Hebei | China |
| Affiliated Hospital of Chengde Medical University | Chengde | Hebei | China |
| Shijiazhuang Hospital of Traditional Chinese Medicine | Shijiazhuang | Hebei | China |
| The First Hospital of Hebei Medical University | Shijiazhuang | Hebei | China |
| People Hospital of Xingtai | Xingtai | Hebei | China |
| The Second Affiliated Hospital of Xingtai Medical College | Xingtai | Hebei | China |
| Anyang District Hospital | Anyang | Henan | China |
| The Second Affiliated Hospital of Henan University of Science and Technology | Luoyang | Henan | China |
| Sanmenxia Central Hospital | Sanmenxia | Henan | China |
| Jingzhou Central Hospital | Jingzhou | Hubei | China |
| Renmin Hospital of Wuhan University | Wuhan | Hubei | China |
| Wuhan No.1 Hospital | Wuhan | Hubei | China |
| Changde First People's Hospital | Changde | Hunan | China |
| XiangYa Hospital CentralSouth University | Changsha | Hunan | China |
| Yueyang Central Hospital | Yueyang | Hunan | China |
| The Affiliated Hospital of Inner Mongolia Medical College | Hohhot | Inner Mongolia | China |
| Affiliated Hospital of Nantong University | Nantong | Jiangsu | China |
| Wuxi People's Hospital | Wuxi | Jiangsu | China |
| Affiliated Hospital of Jiangsu University | Zhenjiang | Jiangsu | China |
| The Affiliated Hospital of Yanbian University Yanbian Hospital | Yanbian | Jilin | China |
| Qilu Hospital of Shandong University | Jinan | Shandong | China |
| Shandong First Medical University Affiliated Dermatology Hospital | Jinan | Shandong | China |
| Yantai Yuhuangding Hospital | Yantai | Shandong | China |
| Shanghai Skin Disease Hospital | Shanghai | Shanghai Municipality | China |
| Shanghai Yueyang Integrated Traditional Chinese Medicine and Western Medicine Hospital | Shanghai | Shanghai Municipality | China |
| Taiyuan Central Hospital | Taiyuan | Shanxi | China |
| Sichuan Provincial People's Hospital | Chengdu | Sichuan | China |
| The Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine | Tianjin | Tianjin Municipality | China |
| Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital | Tianjin | Tianjin Municipality | China |
| Xinjiang Uygur Municipal People's Hospital | Ürümqi | Xinjiang | China |
| The First Affiliated Hospital of Kunming Medical University | Kunming | Yunnan | China |
| Qujing No.1 Hospital | Qujing | Yunnan | China |
| Affiliated Hangzhou First People's Hospital | Hangzhou | Zhejiang | China |
| Hangzhou Third People's Hospital | Hangzhou | Zhejiang | China |
| The Second Affiliated Hospital of Zhejiang University School of Medicine | Hangzhou | Zhejiang | China |
| Jiaxing Second Hospital | Jiaxing | Zhejiang | China |
| The First Hospital of Jiaxing | Jiaxing | Zhejiang | China |
| Ningbo No.2 Hospital | Ningbo | Zhejiang | China |
| Taizhou Central Hospital | Taizhou | Zhejiang | China |
| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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