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This trial was designed to evaluate the efficacy and safety of SHR-1819 injection in patients with Prurigo Nodularis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR-1819 Injection Group | Experimental | SHR-1819 injection with different doses. |
|
| SHR-1819 Injection Placebo Group | Placebo Comparator | SHR-1819 injection placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-1819 Injection | Drug | SHR-1819 injection. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Phase II: Proportion of subjects with a ≥ 4-point reduction from baseline in the weekly mean of the Most Intense Pruritus Numeric Rating Scale (WI-NRS) at Week 16 | Participants were asked daily to rate the intensity of their worst pruritus (itch) over the past 24 hours, using a 11-point scale ranging from 0 (no itch) to 10 (worst imaginable itch). Higher scores indicated more severity. | Up to 16 weeks. |
| Phase III: Proportion of subjects with a ≥ 4-point reduction from baseline in the weekly mean of the Most Intense Pruritus Numeric Rating Scale (WI-NRS) at Week 24 | Participants were asked daily to rate the intensity of their worst pruritus (itch) over the past 24 hours, using a 11-point scale ranging from 0 (no itch) to 10 (worst imaginable itch). Higher scores indicated more severity. | Up to 24 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Phase II: Weekly mean change from baseline and percentage change in weeks 2, 4, 8, 12, and 16 of WI-NRS | Participants were asked daily to rate the intensity of their worst pruritus (itch) over the past 24 hours, using a 11-point scale ranging from 0 (no itch) to 10 (worst imaginable itch). Higher scores indicated more severity. | Up to 16 weeks. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Huiliu Wang | Contact | +86-0518-82342973 | huiliu.wang.hw330@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University People's Hospital | Recruiting | Beijing | Beijing Municipality | 100032 | China |
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SHR-1819 compared with placebo
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| SHR-1819 Injection Placebo |
| Drug |
SHR-1819 injection placebo. |
|
| Phase II: Proportion of subjects with IGA CNPG-S score of 0/1 at weeks 4, 8, 12 and 16 | It consists of a 5-point scale ranging from 0 to 4 where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe. Higher scores indicate severe PN. | Up to 16 weeks. |
| Phase II: Change from baseline in Dermatology Life Quality Index (DLQI) score at weeks 4, 8, 12, 16 | It comprises of set of 10 questions. Responses to each question were assessed on a 4-point Likert scale ranged from 0 (not at all) to 3 (very much). Scores from all 10 questions added up to give total DLQI scores ranged from 0 (not at all) to 30 (very much), higher scores indicated more impact on quality of life. | Up to 16 weeks. |
| Phase III: Proportion of subjects with an IGA CNPG-S score of 0/1 at Week 24 | It consists of a 5-point scale ranging from 0 to 4 where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe. Higher scores indicate severe PN. | Up to 24 weeks. |
| Phase III: Proportion of subjects with IGA CNPG-S score of 0/1 at every study visit | It consists of a 5-point scale ranging from 0 to 4 where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe. Higher scores indicate severe PN. | Up to 52 weeks. |
| Phase III: Change from baseline in Dermatology Life Quality Index (DLQI) score at every study visit | It comprises of set of 10 questions. Responses to each question were assessed on a 4-point Likert scale ranged from 0 (not at all) to 3 (very much). Scores from all 10 questions added up to give total DLQI scores ranged from 0 (not at all) to 30 (very much), higher scores indicated more impact on quality of life. | Up to 52 weeks. |
| Phase II/III: The concentration of SHR-1819 in serum (AUC) | The concentration of SHR-1819 in plasma will be determined. | From the beginning of administration to the 24/60th week. |
| Phase II/III: Changes in the level of IgE in the serum | Changes in the level of biomarkers in serum. | From the beginning of administration to the 24/60th week. |
| Phase II/III: Immunogenic endpoint - evaluate the incidence of ADA positivity for SHR-1819 | Incidence of immunogenicity in the body. | From the beginning of administration to the 24/60th week. |