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This is a randomized double-blind, placebo-controlled, multicenter phase III clinical study evaluating the efficacy and safety of AK120 injection in the treatment of patients with moderate to severe atopic dermatitis.
This is a randomized double-blind, placebo-controlled, multicenter phase III clinical study evaluating the efficacy and safety of AK120 injection in the treatment of patients with moderate to severe atopic dermatitis. The entire study included a screening period, a double-blind controlled treatment period, a conversion and maintenance treatment period, and a safe follow-up period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AK120 600mg/300mg | Experimental | AK120 600mg(first day) then 300mg Q2W subcutaneous injection thereafter until week 50. |
|
| Placebo/AK120 600mg to 300mg | Placebo Comparator | placebo Q2W SC, then AK120 600mg at week 16, thereafter change to AK120 300mg Q2W subcutaneous injection until week 50. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AK120 | Drug | 300mg Q2W subcutaneous injection thereafter until week 50. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of subjects who achieved (Eczema Area and Severity Index) EASI-75 | Percentage of patients in both treatment group and placebo group who achieved EASI 75 at week 16. | at week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of subjects who achieved 0/1 in the (Investigator's Global Assessment) IGA | The percentage of patients in both treatment group and placebo group who achieved IGA 0/1 score at week 16. | at week 16 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Guoqin Wang | Contact | +86 (0760) 8987 3999 | global.trials@akesobio.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Friendship Hospital Capital Medical University | Recruiting | Beijing | Beijing Municipality | China | ||
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| Beijing Luhe Hospital Affiliated to Capital Medical University |
| Recruiting |
| Beijing |
| Beijing Municipality |
| China |
| Beijing Tongren Hospital | Recruiting | Beijing | Beijing Municipality | China |
| Peking University People's Hospital | Recruiting | Beijing | Beijing Municipality | China |
| Peking University Third Hospital | Recruiting | Beijing | Beijing Municipality | China |
| Chongqing Three Gorges Medical College Affiliated People's Hospital | Recruiting | Chongqing | Chongqing Municipality | China |
| Chongqing Traditional Chinese Medicine Hospital | Recruiting | Chongqing | Chongqing Municipality | China |
| The First Affiliated Hospital of Fujian Medical University | Recruiting | Fuzhou | Fujian | China |
| The Second Affiliated Hospital of Xiamen Medical College | Recruiting | Xiamen | Fujian | China |
| Guangdong Provincial People's Hospital | Recruiting | Guangzhou | Guangdong | China |
| Southern Medical University Dermatology Hospital/Guangdong Provincial Dermatology Hospital | Recruiting | Guangzhou | Guangdong | China |
| Southern Medical University Southern Hospital | Recruiting | Guangzhou | Guangdong | China |
| Sun Yat-sen Memorial Hospital, Sun Yat-sen University | Recruiting | Guangzhou | Guangdong | China |
| The First Affiliated Hospital of Guangzhou Medical University | Recruiting | Guangzhou | Guangdong | China |
| Zhujiang Hospital of Southern Medical University | Recruiting | Guangzhou | Guangdong | China |
| Yuebei People's hospital, Guangdong, China | Recruiting | Shaoguan | Guangdong | China |
| Shunde Hospital of Southern Medical University | Recruiting | Shunde | Guangdong | China |
| Guangdong Medical University Affiliated Hospital | Recruiting | Zhanjiang | Guangdong | China |
| The Affiliated Hospital of Guizhou Medical University | Recruiting | Guiyang | Guizhou | China |
| Hainan General Hospital | Recruiting | Haikou | Hainan | China |
| Hainan Provincial Fifth People's Hospital | Recruiting | Haikou | Hainan | China |
| The First Affiliated Hospital of Hainan Medical College | Recruiting | Haikou | Hainan | China |
| Chengde Medical College Affiliated Hospital | Recruiting | Chengde | Hebei | China |
| The Second Affiliated Hospital of Xingtai Medical College | Recruiting | Xingtai | Hebei | China |
| Harbin Medical University Affiliated Second Hospital | Recruiting | Harbin | Heilongjiang | China |
| Heilongjiang Provincial Hospital | Recruiting | Harbin | Heilongjiang | China |
| The Second Affiliated Hospital of Henan University of Science and Technology | Recruiting | Luoyang | Henan | China |
| Renmin Hospital of Wuhan University Hubei General Hospital | Recruiting | Wuhan | Hubei | China |
| Tongji Hospital | Recruiting | Wuhan | Hubei | China |
| Changde First People's Hospital | Recruiting | Changde | Hunan | China |
| Xiangya Hospital of Central South University | Recruiting | Changsha | Hunan | China |
| The First Affiliated Hospital of South China University | Recruiting | Hengyang | Hunan | China |
| Inner Mongolia Medical University Affiliated Hospital | Recruiting | Hohhot | Inner Mongolia | China |
| The First Affiliated Hospital of Bengbu Medical College | Recruiting | Bengbu | Jiangsu | China |
| Changzhou First People's Hospital | Recruiting | Changzhou | Jiangsu | China |
| Yancheng First People's Hospital | Recruiting | Yancheng | Jiangsu | China |
| Jiangsu University Affiliated Hospital | Recruiting | Zhenjiang | Jiangsu | China |
| The First Affiliated Hospital of Gannan Medical College | Recruiting | Ganzhou | Jiangxi | China |
| The First Bethune Hospital of Jilin University | Recruiting | Changchun | Jilin | China |
| Panjin Liaoyou Gemstone Flower Hospital | Recruiting | Panjin | Liaoning | China |
| Shenyang Integrated Traditional Chinese and Western Medicine Hospital | Recruiting | Shenyang | Liaoning | China |
| Zhongyi Northeast International Hospital | Recruiting | Shenyang | Liaoning | China |
| General Hospital of Ningxia Medical University | Recruiting | Yinchuan | Ningxia | China |
| Shandong Provincial Dermatology Hospital | Recruiting | Jinan | Shandong | China |
| Shandong University Qilu Hospital | Recruiting | Jinan | Shandong | China |
| Qingdao Municipal Hospital | Recruiting | Qingdao | Shandong | China |
| Shanghai Dermatology Hospital | Recruiting | Shanghai | Shanghai Municipality | China |
| Baoji Central Hospital | Recruiting | Baoji | Shanxi | China |
| Sichuan Provincial People's Hospital | Recruiting | Chengdu | Sichuan | China |
| Tianjin Institute of Traditional Chinese Medicine Affiliated Hospital | Recruiting | Tianjin | Tianjin Municipality | China |
| Xinjiang Uygur Autonomous Region People's Hospital | Recruiting | Ürümqi | Xinjiang | China |
| The First Affiliated Hospital of Kunming Medical University | Recruiting | Kunming | Yunnan | China |
| Hangzhou First People's Hospital | Recruiting | Hangzhou | Zhejiang | China |
| Hangzhou Third People's Hospital | Recruiting | Hangzhou | Zhejiang | China |
| The Second Affiliated Hospital of Zhejiang University School of Medicine | Recruiting | Hangzhou | Zhejiang | China |
| Jiaxing First People's Hospital | Recruiting | Jiaxing | Zhejiang | China |
| Ningbo First Hospital | Recruiting | Ningbo | Zhejiang | China |
| Ningbo Huamei Hospital, University of Chinese Academy of Sciences | Recruiting | Ningbo | Zhejiang | China |
| Wenzhou Medical University First Affiliated Hospital | Recruiting | Wenzhou | 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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