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This is a A multicenter, open label, phase II clinical study to evaluate the safety, pharmacokinetics (PK), pharmacodynamics(PD), and preliminary efficacy of AK120 in adolescents with moderate-to-severe atopic dermatitis
This is a A multicenter, open label, phase II clinical study aimed to evaluate the safety, PK, PD, and preliminary efficacy of AK120 in adolescents with moderate-to-severe AD. The entire study include screening period(week -4 to week 0), treatment and follow-up period(16 weeks). The duration of the study is about 20 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AK120 300mg every two weeks (Q2W) subcutaneous injection | Experimental | Subjects with heavy weight |
|
| AK120 300mg every three weeks (Q3W) subcutaneous injection | Experimental | Subjects with light weight |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AK120 | Drug | AK120 subcutaneous injection |
|
| 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 -4 to week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| PK evaluation: maximum plasma concentration (Cmax) | Assessment of Cmax after AK120 administration. | Baseline till last follow-up visit ( up to day 113) |
| PK evaluation: time to maximum plasma concentration (Tmax) |
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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 |
|---|---|---|---|---|---|---|
| Dongguan People's Hospital | Dongguan | Guangdong | China | |||
| The Second Affiliated Hospital of Guangzhou Medical University |
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| 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 |
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Assessment of Tmax after AK120 administration.
| Baseline till last follow-up visit ( up to day 113) |
| PD evaluation: Thymus and activation regulated chemokine (TARC)/CCL17 | Percentage change in TARC/CCL17 compared to baseline. | Baseline till last follow-up visit ( up to day 113) |
| Change in Eczema Area and Severity Index (EASI) scores | Percentage change in EASI scores from baseline. | week 0/2/4/8/12/16 |
| Change in affected Body Surface Area (BSA) scores | Percentage change in BSA score from baseline. | week 0/2/4/8/12/16 |
| Subjects who achieved 0/1 in the Investigator's Global Assessment (IGA) | Percentage of subjects who achieved IGA 0/1. | week 0/2/4/8/12/16 |
| Change in Children's Dermatology Life Quality Index (CDLQI) scores | Percentage change in CDLQI score from baseline. | week 0/2/4/8/12/16 |
| Change in Patient Oriented Eczema Measure (POEM) scores | Percentage change in POEM score from baseline. | week 0/2/4/8/12/16 |
| Guangzhou |
| Guangdong |
| China |
| The University of Hong Kong - Shenzhen Hospital | Shenzhen | Guangdong | China |
| Hunan Pediatric Medical Union | Changsha | Hunan | China |
| Xiangya Hospital Central South University | Changsha | Hunan | China |
| Ning Bo No.2 Hospital | Ningbo | Zhejiang | China |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |