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This study is a multicenter, randomized, double-blind, placebo-controlled phase III clinical study to evaluate the efficacy and safety of Stapokibart Injection in the treatment of subjects with prurigo nodularis, and observe pharmacokinetic characteristics, pharmacological effects, and immunogenicity.
Chronic prurigo (CPG) is an independent chronic inflammatory skin disease characterized by chronic itching and multiple local or systemic prurigo lesions. Prurigo nodularis (PN) is the main subtype of CPG.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stapokibart | Experimental | Stapokibart Injection, subcutaneous injection (SC) |
|
| Placebo | Placebo Comparator | subcutaneous injection (SC) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stapokibart | Biological | Stapokibart Injection |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects with ≥4-point improvement from baseline in the Worst Itch Numerical Rating Scale (WI-NRS) at week 24 | The Worst Itch Numerical Rating Scale (WI-NR) is a patient-reported outcome (PRO) consisting of individual items with scores ranging from 0 ("no itching") to 10 ("the most severe itching imaginable"). Subjects are required to use this scale to rate the severity of their most severe itching in the past 24 hours. | Up to week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects with Investigator's Global Assessment score of 0 or 1 for PN stage (IGA-CNPG S) at week 24 | IGA-CNPG-S stands for Investigator Global Assessment of Chronic Nodular Prurigo - Severity scale, a clinical tool used to rate the overall severity of chronic nodular prurigo (CNPG) by evaluating lesion number, size, and inflammation. | Up to week 24 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xinghua Gao | First Hospital of China Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Hospital of China Medical University | Shenyang | Liaoning | China |
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| Other |
Placebo |
|
| Change from the baseline in the WI-NRS at each other visit | Up to week 24 |
| Proportion of subjects with Investigator's Global Assessment score of 0 or 1 for PN Activity (IGA-CNPG A) at each visit | A clinician-assessed scale to evaluate the overall appearance of lesions in chronic nodular prurigo | Up to week 24 |
| Change from baseline in Dermatology Life Quality Index (DLQI) score at each visit | A patient-reported questionnaire measuring the impact of skin disorders on daily life and quality of life. | Up to week 24 |
| Change from baseline in Skin Pain NRS at each visit | A numerical rating scale for patients to self-assess the intensity of skin pain. | Up to week 24 |
| Change from baseline in Sleep NRS at each visit | A numeric scale used to quantify sleep disturbance caused by disease symptoms. | Up to week 24 |
| Change from baseline in Hospital Anxiety and Depression Scale (HADS) at each visit | A validated scale for screening anxiety and depression symptoms in clinical populations. | Up to week 24 |
| Change from baseline in the European Health Questionnaire 5 Dimensions (EQ-5D-5L) at each visit | A standard five-dimension tool to evaluate general health status and health-related quality of life. | Up to week 24 |
| Safety parameters | Incidence of treatment-emergent adverse events (TEAEs). | Up to week 32 |
| Pharmacokinetics (PK) | Concentration of CM310 in serum | Up to week 32 |
| Pharmacodynamics (PD) | Change from baseline in serum thymus activation-regulated chemokine (TARC) concentration. | Up to week 32 |
| Anti-drug antibodies (ADA) | Incidence of ADA. | Up to week 32 |
| Pharmacodynamics (PD) | Change from baseline in serum total immunoglobulin E (IgE) concentration. | Up to week 32 |