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This is a multicenter, randomized, double-blind, placebo-controlled Phase III clinical study to evaluate the efficacy, safety, PK characteristics of ICP-488 in Chinese adults with moderate to severe plaque psoriasis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ICP-488 Tablets | Experimental |
| |
| ICP-488 Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ICP-488 Tablets | Drug | Eligible patients will receive ICP-488 orally as per the protocol |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of subjects who achieve a score of clear (0) or almost clear (1) with an improvement of at least 2 points from baseline on the static Physician's Global Assessment (sPGA) at week 16 | week 16 | |
| Percentage of subjects who achieved a PASI 75 response (a reduction of minimum 75% from baseline in PASI score) at Week 16 | Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | Week 52 | |
| Percentage of subjects with PASI 50/75/90/100 in each planned visit | Week 52 | |
| Percentage of subjects with sPGA score of 0 (clear) or 1 (almost clear) and an improvement of at least 2 points from baseline in planned visits. |
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Inclusion Criteria:
Eligible subjects must meet all of the following criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alexia Lu | Contact | 010-66609745 | CO_HGRAC@innocarepharma.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Anhui Medical University | Completed | Hefei | Anhui | 230022 | China | |
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| ICP-488 Placebo |
| Drug |
Eligible patients will receive ICP-488 Placebo orally as per the protocol |
|
| Week 52 |
| The proportion of subjects with sPGA score of 0 in each planned visit. | Week 52 |
| PK parameter: ICP-488 and its metabolite. | Week 52 |
| The Second Affiliated Hospital of Wannan Medical College |
| Completed |
| Wuhu |
| Anhui |
| 241000 |
| China |
| Beijing Chao-Yang Hospital,Capital Medical University | Completed | Beijing | Beijing Municipality | 100020 | China |
| Beijing Friendship Hospital, Capital Medical University | Completed | Beijing | Beijing Municipality | 100050 | China |
| Peking University Third Hospital | Completed | Beijing | Beijing Municipality | 100191 | China |
| Beijing Tongren Hospital,CMU | Completed | Beijing | Beijing Municipality | 100730 | China |
| The First Affiliated Hospital of Chongqing Medical University | Completed | Chongqing | Chongqing Municipality | 400016 | China |
| Chongqing Traditional Chinese Medicine Hospital | Completed | Chongqing | Chongqing Municipality | 400021 | China |
| Fujian Medical University Union Hospital | Completed | Fuzhou | Fujian | 350001 | China |
| The First Affiliated Hospital of Fujian Medical University | Completed | Fuzhou | Fujian | 350005 | China |
| Dermatology Hospital of Southern Medical University | Completed | Guangzhou | Guangdong | 510091 | China |
| Sun Yat-sen Memorial Hospital, Sun Yat-sen University | Completed | Guangzhou | Guangdong | 510120 | China |
| Liuzhou People's Hospital | Completed | Liuzhou | Guangxi | 545006 | China |
| The Affiliated Hospital of Guizhou Medical University | Completed | Guiyang | Guizhou | 550001 | China |
| Affiliated Hospital of Chengde Medical University | Completed | Chengde | Hebei | 067000 | China |
| The Second Hospital of Hebei Medical University | Completed | Shijiazhuang | Hebei | 050000 | China |
| The 2nd Affiliated Hospital of Harbin Medical University | Completed | Harbin | Heilongjiang | 150001 | China |
| The Second Affiliated Hospital of Henan University of Science and technology | Completed | Luoyang | Henan | 471000 | China |
| Nanyang Central Hospital | Completed | Nanyang | Henan | 473000 | China |
| Sanmenxia Central Hospital | Completed | Sanmenxia | Henan | 472000 | China |
| Henan Provincial People's Hospital | Completed | Zhengzhou | Henan | 450003 | China |
| Jingzhou Central Hospital | Completed | Jingzhou | Hubei | 434020 | China |
| Wuhan Hospital Of Traditional Chinese and Western Medicine (Wuhan No.1 Hospital) | Completed | Wuhan | Hubei | 430022 | China |
| Xiangya Hospital of Central South University | Completed | Changsha | Hunan | 410008 | China |
| The Second Xiangya Hospital of Central South | Completed | Changsha | Hunan | 410011 | China |
| The First People's Hospital of Changzhou | Completed | Changzhou | Jiangsu | 213003 | China |
| The First People's Hospital of Lianyungang | Completed | Lianyungang | Jiangsu | 222002 | China |
| Hospital for skin diseases,Institute of dermatology chinese academy of medical sciences,peking union medical college | Completed | Nanjing | Jiangsu | 210042 | China |
| First Affiliated Hospital of Gannan Medical University | Completed | Ganzhou | Jiangxi | 341000 | China |
| Dermatology Hospital of Jiangxi Province | Completed | Nanchang | Jiangxi | 330000 | China |
| The First Hospital of Jilin University | Completed | Changchun | Jilin | 130021 | China |
| Northeast International Hospital | Completed | Shenyang | Liaoning | 110000 | China |
| Qilu Hospital of Shandong University | Completed | Jinan | Shandong | 250012 | China |
| Huashan Hospital, Fudan University | Completed | Shanghai | Shanghai Municipality | 200040 | China |
| Shanghai Skin Disease Hospital skin Disease of tongji University | Completed | Shanghai | Shanghai Municipality | 200443 | China |
| Taiyuan Central Hospital | Completed | Taiyuan | Shanxi | 030009 | China |
| The First Affiliated Hospital of Xi'an Jiaotong University | Recruiting | Xi’an | Shanxi | 710061 | China |
|
| The Second Affiliated Hospital of Xi'an Jiaotong University | Completed | Xi’an | Shanxi | 710114 | China |
| Chengdu Second People's Hospital | Completed | Chengdu | Sichuan | 610017 | China |
| Sichuan Provincial People's Hospital | Completed | Chengdu | Sichuan | 610072 | China |
| Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital | Completed | Tianjin | Tianjin Municipality | 300120 | China |
| The First Affiliated Hospital of Kunming Medical University | Completed | Kunming | Yunnan | 650032 | China |
| The Second Affiliated Hospital Zhejiang University School of Medicine | Completed | Hangzhou | Zhejiang | 310009 | China |
| The Fourth Affiliated Hospital, Zhejiang University School of Medicine | Completed | Jinhua | Zhejiang | 322000 | China |
| The First Affiliated Hospital Of Ningbo University | Recruiting | Ningbo | Zhejiang | 315000 | China |
|
| The first Affiliated hospital of Wenzhou Medical University | Completed | Wenzhou | Zhejiang | 325000 | China |