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This trial was designed to evaluate the efficacy and safety of SHR-1819 in adolescents with moderate-to-severe atopic dermatitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR-1819 Injection Group with Dose 1 | Experimental | Dose 1. |
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| SHR-1819 Injection Placebo Group with Dose 1 | Placebo Comparator | Dose 1. |
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| SHR-1819 Injection Group with Dose 2 | Experimental | Dose 2. |
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| SHR-1819 Injection Placebo Group with Dose 2 | Placebo Comparator | Dose 2. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-1819 Injection | Drug | SHR-1819 injection. |
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| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with Eczema Area and Severity (EASI)-75. | EASI-75: ≥ 75% improvement from baseline. | At week 16. |
| Proportion of patients with an Investigator's Global Assessment (IGA) score of either 0 or 1. | On a 5-point scale. | At week 16. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with improvement (reduction) of weekly average of daily peak Pruritus Numerical Rating Scale (NRS) ≥ 4 from baseline to week 16. | From baseline up to week 16. | |
| Proportion of patients with Eczema Area and Severity (EASI)-90. | EASI-90: ≥ 90% improvement from baseline. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaoyan Bai | Contact | +86-0518-82342973 | xiaoyan.bai.xb1@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of China Medical University | Recruiting | Shenyang | Liaoning | 110002 | China |
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| SHR-1819 Injection Placebo | Drug | SHR-1819 injection placebo. |
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| At week 16. |
| Proportion of patients with Eczema Area and Severity (EASI)-75. | EASI-75: ≥ 75% improvement from baseline. | At Week 1, 2, 4, 8 and 12. |
| Proportion of patients with an Investigator's Global Assessment (IGA) score of either 0 or 1. | At Week 1, 2, 4, 8 and 12. |
| Proportion of patients with an Investigator's Global Assessment (IGA) score of a ≥ 2-point reduction from baseline. | At Week 1, 2, 4, 8 and 12. |
| The time from baseline to first achievement of EASI-75 by Week 16. | By Week 16. |
| The time from baseline to first achievement of EASI-50 by Week 16. | By Week 16. |
| The time from baseline to first achievement of EASI-90 by Week 16. | By Week 16. |
| Proportion of participants achieving EASI-50. | At Week 1, 2, 4, 8, 12 and 16. |
| Proportion of participants achieving EASI-90. | At Week 1, 2, 4, 8, 12 and 16. |
| Change and percentage change in atopic dermatitis (AD)-affected body surface area (BSA) from baseline. | At Week 1, 2, 4, 8, 12 and 16. |
| Change and percentage change in Children's Dermatology Life Quality Index (CDLQI) score from baseline. | At Week 1, 2, 4, 8, 12 and 16. |
| Change and percentage change in Patient-Oriented Eczema Measure (POEM) score from baseline. | At Week 1, 2, 4, 8, 12 and 16. |
| Proportion of participants with a ≥ 2-point reduction in Investigator's Global Assessment (IGA) score from baseline. | At Week 1, 2, 4, 8, 12 and 16. |
| Xinhua Hospital Affiliated to Shanghai JiaoTong University School of Medicine | Recruiting | Shanghai | Shanghai Municipality | 200092 | China |
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