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This trial is planned to investigate the efficacy and safety of Stapokibart (an IL-4 receptor antagonist) in patients with PCA.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stapokibart | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stapokibart | Biological | A humanized monoclonal antibody that targets the interleukin (IL)-4 receptor subunit alpha |
|
| Measure | Description | Time Frame |
|---|---|---|
| The percentage of subjects achieving AASI-75 at Week 16 of treatment | AASI: Amyloidosis Area and Severity Index. The minimum and maximum values: 0-72. Higher scores mean more serious situations. AASI-75: A 75% or greater improvement from baseline in the AASI. The minimum and maximum values: 0%-100%. Higher scores mean a better outcome. | At the end of treatment at 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The percentage of subjects with a weekly average reduction of≥4 points in PP-NRS score at Week 16 of treatment compared to baseline | PP-NRS: Peak Pruritus Numerical Rating Scale. The minimum and maximum values: 0-10. Higher scores mean more serious situations. | At the end of treatment at 16 weeks |
| The percentage of subjects with an IGA score of 0 or 1 and a reduction of≥2 points compared to baseline. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety Endpoints:Including the occurrence of AEs(Adverse Events),and abnormalities in laboratory tests,physical examinations,and vital signs. | At the end of treatment at 16 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 4, 2025 | Aug 13, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 31, 2025 | Aug 13, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| C562642 | Amyloidosis, Primary Cutaneous |
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| Placebo drug | Other | Placebo drugs without Stapokibart |
|
IGA: Investigator Global Assessment. The minimum and maximum values: 0-4. Higher scores mean more serious situations. |
| At the end of treatment at 16 weeks |
| The percentage of subjects achieving AASI-50 compared to baseline. | AASI: Amyloidosis Area and Severity Index. The minimum and maximum values: 0-72. Higher scores mean more serious situations. AASI-50: A 50% or greater improvement from baseline in the AASI. The minimum and maximum values: 0%-100%. Higher scores mean a better outcome. | At the end of treatment at 16 weeks |
| The percentage of subjects with a weekly average reduction of≥3 points in PP-NRS score compared to baseline | PP-NRS: Peak Pruritus Numerical Rating Scale. The minimum and maximum values: 0-10. Higher scores mean more serious situations. | At the end of treatment at 16 weeks |
| Change rates in BSA involvement compared to baseline. | BSA: Body Surface Area. The minimum and maximum values: 0-100%. Higher scores mean more serious situations. | At the end of treatment at 16 weeks |
| Changes in DLQI scores compared to baseline. | DLQI: Dermatology Life Quality Index. The minimum and maximum values: 0-30. Higher scores mean more serious situations. | At the end of treatment at 16 weeks |
| Changes in absolute eosinophil counts in complete blood counts compared to baseline. | At the end of treatment at 16 weeks |
| Changes in IgE levels in complete blood counts compared to baseline. | At the end of treatment at 16 weeks |
| Changes in histopathology of skin lesions compared to baseline in some subjects | At the end of follow-up at 28 weeks |