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Evaluate the efficacy and safety of ICP-332 in participants with Prurigo Nodularis (PN)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ICP-332 80mg | Experimental |
| |
| ICP-332 120mg | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ICP-322 | Drug | ICP-322 Tablets |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Peak pruritus-numeric rate scale (PP NRS) | Percent change from baseline of weekly average in Peak pruritus-numeric rate scale (PP NRS) at Week 16. Participants will be asked to rate their itch at the worst moment during the previous 24 hours. On a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable'. | Baseline to week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in PP NRS score | Proportion of participants achieving ≥ 4-point improvement in PP NRS score (PP NRS ≥ 4) over time | Baseline through week 40 |
| Investigator's Global Assessment for Chronic Prurigo Stage scores of 0 or 1 (IGA-CPG-S 0/1) |
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Inclusion Criteria :
Willingness to avoid pregnancy or fathering children
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alexia Lu | Contact | +86-010-66609745 | CO_HGRAC@innocarepharma.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Apex Clinical Research Center | Recruiting | Mayfield Heights | Ohio | 44124 | United States |
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| Placebo |
| Drug |
ICP-332 Placebo Tablets |
|
Proportion of participants achieving Investigator's Global Assessment for Chronic Prurigo Stage scores of 0 or 1 (IGA-CPG-S 0/1) over time
| Baseline through week 40 |
| Dermatology Life Quality Index (DLQI) | Change from baseline in Dermatology Life Quality Index (DLQI) score over time. The DLQI comprises 10 items assessing the impact of skin disease on patients' health-related quality of life (HRQoL) over the previous week. Overall scoring ranges from 0 to 30, with a high score indicative of a poor HRQoL | Baseline through week 40 |
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | Baseline through week 40 |
| Maximum concentration (Cmax) | Maximum concentration (Cmax) of ICP-322 | Baseline through week 40 |
| Area Under Concentration Versus Time Curve (AUC) | Area Under Concentration Versus Time Curve (AUC) of ICP-322 | Baseline through week 40 |
| The Second Affiliated Hospital of Wannan Medical College | Recruiting | Wuhu | Anhui | 241000 | China |
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| Peking University People's Hospital | Recruiting | Beijing | Beijing Municipality | 100044 | China |
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| The First Affiliated Hospital of Chongqing Medical University | Recruiting | Chongqing | Chongqing Municipality | 400016 | China |
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| The First Affiliated Hospital of Fujian Medical University | Recruiting | Fuzhou | Fujian | 350005 | China |
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| Dermatology Hospital of Southern Medical University | Recruiting | Guangzhou | Guangdong | 510091 | China |
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| The First Hospital of Hebei Medical University | Recruiting | Shijiazhuang | Hebei | 050000 | China |
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| Jingzhou Central Hospital | Recruiting | Jingzhou | Hubei | 434020 | China |
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| Xiangya Hospital of Central South University | Recruiting | Changsha | Hunan | 410008 | China |
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| The first hospital of Jilin University | Recruiting | Changchun | Jilin | 130021 | China |
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| Shenyang Seventh People's Hospital | Recruiting | Shenyang | Liaoning | 110003 | China |
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| Shandong Provincial Dermatology Hospital | Recruiting | Jinan | Shandong | 250022 | China |
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| Chengdu Second People's Hospital | Recruiting | Chengdu | Sichuan | 610021 | China |
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| Sichuan Provincial People's Hospital | Recruiting | Chengdu | Sichuan | 610072 | China |
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| Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital | Recruiting | Tianjin | Tianjin Municipality | 300131 | China |
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| Affiliated Hangzhou First People's Hospital,School of Medicine ,Westlake University | Recruiting | Hangzhou | Zhejiang | 250022 | China |
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