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This trial was designed to evaluate the efficacy and safety of SHR-1905 in patients with moderate-to-severe atopic dermatitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR-1905 Injection Group - Dose 1 | Experimental | Dose 1. |
|
| SHR-1905 Injection Placebo Group | Placebo Comparator |
| |
| SHR-1905 Injection Group - Dose 2 | Experimental | Dose 2. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-1905 Injection | Drug | SHR-1905 injection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of subjects whose Eczema Area and Severity Index (EASI) score decreased ≥ 75% compared to the baseline. | Eczema Area and Severity Index (EASI) score using the Eczema Area and Severity Index scale. | Week 16. |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of subjects with Investigator's Global Assessment (IGA) score of 0 or 1 (on a 0-4 scale) and a decrease of ≥2 points from the baseline. | Investigator's Global Assessment (IGA) score using the Investigator Global Assessment (IGA) scale. | At Day14、Day28、Day56、Day84、Day112、Day140、Day168、Day210、Day252. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ran Li | Contact | +86-0518-82342973 | ran.li@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dermatology Hospital of Southern Medical University | Recruiting | Guangzhou | Guangdong | 510091 | China |
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| SHR-1905 Injection Blank Preparation | Drug | SHR-1905 injection blank preparation. |
|
| The proportion of subjects whose Investigator's Global Assessment (IGA) score decreased ≥ 2 points compared to the baseline. |
Investigator's Global Assessment (IGA) score using the Investigator Global Assessment (IGA) scale. |
| At Day14、Day28、Day56、Day84、Day112、Day140、Day168、Day210、Day252. |
| The change value of change in the Itch Numeric Rating Scale (Itch-NRS) score from the baseline. | The Itch Numeric Rating Scale (Itch-NRS) score using the the Worst Itch Numeric Rating Scale. | At Day14、Day28、Day56、Day84、Day112、Day140、Day168、Day210、Day252. |
| The percentage of change in the Itch Numeric Rating Scale (Itch-NRS) score from the baseline. | The Itch Numeric Rating Scale (Itch-NRS) score using the the Worst Itch Numeric Rating Scale. | At Day14、Day28、Day56、Day84、Day112、Day140、Day168、Day210、Day252. |
| The proportion of subjects whose EASI score decreased ≥ 75% compared to the baseline. | EASI score using the EASI scale. | At Day14、Day28、Day56、Day84、Day112、Day140、Day168、Day210、Day252. |
| The proportion of subjects whose EASI score decreased ≥ 90% compared to the baseline. | EASI score using the EASI scale. | At Day14、Day28、Day56、Day84、Day112、Day140、Day168、Day210、Day252. |
| The proportion of subjects whose EASI score decreased ≥ 50% compared to the baseline. | EASI score using the EASI scale. | At Day14、Day28、Day56、Day84、Day112、Day140、Day168、Day210、Day252. |
| The change value in EASI score from the baseline. | EASI score using the EASI scale. | At Day14、Day28、Day56、Day84、Day112、Day140、Day168、Day210、Day252. |
| The percentage of change in EASI score from the baseline. | EASI score using the EASI scale. | At Day14、Day28、Day56、Day84、Day112、Day140、Day168、Day210、Day252. |
| The change in Body Surface Area Involvement of Atopic Dermatitis (BSA) from the baseline. | BSA score using the BSA scale. | At Day14、Day28、Day56、Day84、Day112、Day140、Day168、Day210、Day252. |
| The percentage of change in Body Surface Area Involvement of Atopic Dermatitis (BSA) from the baseline. | BSA score using the BSA scale. | At Day14、Day28、Day56、Day84、Day112、Day140、Day168、Day210、Day252. |
| Adverse events (AEs). | At Day14、Day28、Day56、Day84、Day112、Day140、Day168、Day210、Day252. |