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This is a multicenter, randomized, double-bind and placebo-controlled phase IIa dose-finding study to assess the safety and efficacy of HWH486 in adults with chronic spontaneous urticaria (CSU). In addition, the pharmacokinetic characteristics will also be investigated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HWH486 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HWH486 | Drug | HWH486 capsule was administrated orally |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Urticaria Activity Score (UAS) over a 7-day period (UAS7) | Weekly Urticaria Activity Score (UAS7; range 0-42; higher scores reflect greater disease activity) | Baseline, Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Hive Severity Score (HSS) over a 7-day period (HSS7) | Weekly Hives Severity Score (HSS7; range 0-21; higher scores reflect greater wheals) | Baseline to Week 4 |
| Change in Itch Severity Score (ISS) over a 7-day period (ISS7) |
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Inclusion Criteria:
6) Written informed consent signed voluntarily by the patient or their legal representatives.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jie ZHU | Contact | +86 027 87055350 | zhujie@renfu.com.cn | |
| Yaojun XUE | Contact | +86 027 87055350 | xueyaojun@renfu.com.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West China Hospital,Sichuan University | Recruiting | Chengdu | Sichuan | China |
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| ID | Term |
|---|---|
| D000080223 | Chronic Urticaria |
| ID | Term |
|---|---|
| D014581 | Urticaria |
| D017445 | Skin Diseases, Vascular |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| Drug |
Matching placebo was administrated orally |
|
Weekly Itch Severity Score (ISS7; range 0-21; higher scores reflect greater itching)
| Baseline to Week 4 |
| D006969 |
| Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |