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This is a multicenter, randomized, open label phase II clinical study to evaluate the safety and efficacy of AK120 in the treatment of subjects with moderate to severe atopic dermatitis.
This is a multicenter, randomized, open label phase II clinical study to evaluate the safety and efficacy of AK120 in the treatment of subjects with moderate to severe atopic dermatitis. The total duration of the study (including screening period) planned for each subject is approximately 29 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AK120 300mg | Experimental | AK120 loading dose 600mg, then 300mg subcutaneous injection every 2 weeks thereafter until week 14. |
|
| AK120 450mg | Experimental | AK120 loading dose 600mg, then 450mg subcutaneous injection every 2 weeks thereafter until week 14. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AK120 | Drug | subcutaneous injection every 2 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events(AE) | 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 | week 0 to week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of subjects who achieved (Eczema Area and Severity Index) EASI-75 | at week 2/4/8/12/16 /20 and 24 | |
| Percentage of subjects who achieved (Eczema Area and Severity Index) EASI-50 | at week 2/4/8/12/16 /20 and 24 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Anhui Medical University | Hefei | Anhui | China | |||
| Air Force Medical Center |
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| Percentage change in (Eczema Area and Severity Index) EASI scores from baseline | at week 2/4/8/12/16 /20 and 24 |
| Percentage of subjects who achieved 0/1 in the (Investigator's Global Assessment) IGA | at week 2/4/8/12/16 /20 and 24 |
| Percentage of subjects with a (Investigator's Global Assessment) IGA score decrease of ≥ 2 points from baseline | at week 2/4/8/12/16 /20 and 24 |
| Percentage change in (affected body surface area) BSA score from baseline | at week 2/4/8/12/16 /20 and 24 |
| Beijing |
| Beijing Municipality |
| China |
| China-Japan Friendship Hospital | Beijing | Beijing Municipality | China |
| Peking University Third Hospital | Beijing | Beijing Municipality | China |
| The Second Affiliated Hospital of Xiamen Medical College | Xiamen | Fujian | China |
| Dongguan People's Hospital | Dongguan | Guangdong | China |
| Dermatology Hospital of Southern Medical University | Guangzhou | Guangdong | China |
| Sun Yat-sen Memorial Hospital, Sun Yat-sen University | Guangzhou | Guangdong | China |
| Zhujiang Hospital of Southern Medical University | Guangzhou | Guangdong | China |
| Shenzhen People's Hospital | Shenzhen | Guangdong | China |
| The Second Hospital of Hebei Medical University | Shijiazhuang | Hebei | China |
| People Hospital of Xingtai | Xingtai | Hebei | China |
| Renmin Hospital of Wuhan University Hubei General Hospital | Wuhan | Hubei | China |
| Affiliated Hospital of Nantong University | Nantong | Jiangsu | China |
| Yancheng No.1 People's Hospital | Yancheng | Jiangsu | China |
| The Second Affiliated Hospital of Nanchang University | Nanchang | Jiangxi | China |
| General Hospital of Ningxia Medical University | Yinchuan | Ningxia | China |
| Qingdao Municipal Hospital | Qingdao | Shandong | China |
| Baoji Central Hospital | Baoji | Shanxi | China |
| Second Hospital of Shanxi Medical University | Taiyuan | Shanxi | China |
| Taiyuan Central Hospital | Taiyuan | Shanxi | China |
| Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital | Tianjin | Tianjin Municipality | China |
| The First Affiliated Hospital,Zhejiang University School of Medicine | Hangzhou | Zhejiang | China |
| Ningbo No.2 Hospital | Ningbo | Zhejiang | China |
| The first affiliated Hospital of Wenzhou Medical University | Wenzhou | Zhejiang | China |
| The Fourth Affiliated Hospital of Zhejiang University School of Medicine | Yiwu | 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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