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This is a randomized double-blind, placebo-controlled, multicenter phase III clinical study evaluating the efficacy and safety of AK120 in the treatment of moderate-to-severe AD in adolescents.
This is a randomized double-blind, placebo-controlled, multicenter phase III clinical study to evaluate the safety and efficacy of AK120 in the treatment of moderate-to-severe AD in adolescents. The total duration of the study planned is approximately 57 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AK120 600mg every two weeks (Q2W) subcutaneous injection | Experimental | AK120 600mg at day 1, then 300mg subcutaneous injection Q2W thereafter until week 46. |
|
| AK120 600mg every three weeks (Q3W) subcutaneous injection | Experimental | AK120 600mg at day 1, then 300mg subcutaneous injection Q3W thereafter until week 45. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | placebo subcutaneous injection Q2W until week 46. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of subjects who achieved Eczema Area and Severity Index (EASI)-75 | At week 18, the percentage of subjects who achieved EASI-75 compared to baseline. The EASI score ranges from 0 (no eczema) to 72 (maximum severity). | at week 18 (day 127) |
| Percentage of subjects with the Investigator's Global Assessment (IGA) score decrease of ≥ 2 points | At week 18, the percentage of subjects with the IGA score decrease of ≥ 2 points from baseline. The IGA is a five-point scale ranging from 0 to 4 ( 0 indicates clear, 4 indicates severe). | at week 18 (day 127) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage change in affected Body Surface Area (BSA) | Percentage change in BSA from baseline. | week 0 to week 52 |
| percentage change of Peak Pruritus Numerical Rating Scale (P-NRS) scores | percentage change of P-NRS scores from baseline at each visit. The scale ranging from 0 to 10 ( 0=no itch; 10=worst itch imaginable). |
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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 |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital of Wannan Medical College | Wuhu | Anhui | China | |||
| Peking University People's Hospital |
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| placebo | Drug | placebo subcutaneous injection Q3W until week 45. |
|
| week 0 to week 52 |
| Percentage changes in the Children's Dermatology Life Quality Index (CDLQI) score | Percentage changes in the CDLQI score compared to baseline at each visit. The total score range from 0 to 30, with higher scores indicating a greater impact on the patient's quality of life. | week 0 to week 52 |
| 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 52 |
| Beijing |
| Beijing Municipality |
| China |
| Chongqing Traditional Chinese Medicine Hospital | Chongqing | Chongqing Municipality | China |
| The First Affiliated Hospital of Chongqing Medical University | Chongqing | Chongqing Municipality | 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 |
| The First Affiliated Hospital of Jinan University | Guangzhou | Guangdong | China |
| The Second Affiliated Hospital of Guangzhou Medical University | Guangzhou | Guangdong | China |
| Jiangmen Central Hospital | Jiangmen | Guangdong | China |
| The University of Hong Kong - Shenzhen Hospital | Shenzhen | Guangdong | China |
| The Third People's Hospital of Zhuhai | Zhuhai | Guangdong | China |
| Liuzhou Worker's Hospital | Liuzhou | Guangxi | China |
| Jinzhou Central Hospital | Jinzhou | Hubei | China |
| Tongji Hospital | Wuhan | Hubei | China |
| Hunan Children's Hospital | Changsha | Hunan | China |
| XiangYa Hospital CentralSouth University | Changsha | Hunan | China |
| Affiliated Hospital of Jiangsu University | Zhenjiang | Jiangsu | China |
| Dermatology Hospital of Jiangxi Province | Nanchang | Jiangxi | China |
| Shandong Provincial Dermatology Hospital | Jinan | Shandong | China |
| Jining First People's Hospital | Jining | Shandong | China |
| Huashan Hospital, Fudan University | Shanghai | Shanghai Municipality | China |
| Longhua Hospital Shanghai University of Traditional Chinese Medicine | Shanghai | Shanghai Municipality | China |
| Shanghai Skin Disease Hospital | Shanghai | Shanghai Municipality | China |
| The First Affiliated Hospital of Xi'an Jiao Tong University | Xi’an | Shanxi | China |
| Sichuan Provincial People's Hospital | Chengdu | Sichuan | China |
| The First Affiliated Hospital of Kunming Medical University | Kunming | Yunnan | China |
| The First Hospital of Jiaxing | Jiaxing | 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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