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This is a randomized, double-blind phase II clinical study to evaluate the efficacy and safety of AK139 in the treatment of patients with moderate-to-severe atopic dermatitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: AK139 regimen 1 | Experimental |
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| Part 1: AK139 regimen 2 | Experimental |
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| Part 1: AK139 regimen 3 | Experimental |
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| Part 1: AK139 regimen 4 | Experimental |
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| Part 2: AK139 regimen 5 | Experimental |
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| Part 2: AK139 regimen 6 | Experimental |
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| Part 2: Placebo | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AK139 and placebo | Biological | AK139 plus placebo regimen 1-subcutaneous injection. |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity grading of Adverse Events (AE)(applicable to Part 1) | Up to Week 16 (applicable to the Q4W dosing group); Up to Week 8 (applicable to the Q2W dosing group). | |
| Percentage of patients who achieved Eczema Area and Severity Index (EASI)-75 (applicable to Part 2) | at week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients achieving an IGA score of 0 or 1 at each visit, with a reduction of ≥2 points from baseline | Up to Week 24 | |
| Percentage change in affected Body Surface Area (BSA) | Up to week 24 |
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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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| AK139 | Biological | AK139 regimen 2-subcutaneous injection. |
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| AK139 and placebo | Biological | AK139 plus placebo regimen 3-subcutaneous injection. |
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| AK139 | Biological | AK139 regimen 4-subcutaneous injection. |
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| AK139 and placebo | Biological | AK139 plus placebo regimen 5-subcutaneous injection. |
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| AK139 and placebo | Biological | AK139 plus placebo regimen 6-subcutaneous injection. |
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| Placebo | Biological | Placebo-subcutaneous injection |
|
| Percentage change of Peak Pruritus Numerical Rating Scale (P-NRS) scores | Up to week 24 |
| Percentage changes in the Dermatology Life Quality Index (DLQI) score | Up to week 24 |