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This is a multicenter, randomized, double-blind, placebo-controlled Phase II clinical study to evaluate the efficacy and safety of ICP-488 in subjects with cutaneous lupus erythematosus (CLE).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ICP-488 Dose A | Experimental |
| |
| ICP-488 Dose B | Experimental |
| |
| ICP-488 Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ICP-488 Tablets | Drug | Patients will receive ICP-488 orally as per the protocol |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The percentage change of Cutaneous lupus erythematosus disease area and severity index-activity(CLASI-A) relative to the baseline at week 16. | All the subjects completed the 16-week assessment. |
| Measure | Description | Time Frame |
|---|---|---|
| At each visit, the proportion of subjects whose CLASI-A score improved by ≥50% compared to the baseline value (CLASI-50). | From baseline to week 28 | |
| The proportion of subjects with disease improvement as defined by a reduction of ≥4 points relative to the baseline value of CLASI-A (CLASI ≥ 4)at each visit. |
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Inclusion Criteria:
Exclusion Criteria:
5. Other autoimmune diseases except for secondary Sjögren's syndrome. 6. Concurrent herpes zoster infection at screening or before dosing on Day 1, or a history of severe herpes zoster or severe herpes simplex infection.
7. Positive Hepatitis B surface Antigen (HBsAg) at screening; or abnormal Hepatitis B Virus (HBV)Deoxyribonucleic Acid (DNA) Polymerase Chain Reaction (PCR) test result in subjects positive for Hepatitis B core Antibody (HBcAb).
8 Evidence of active, latent, or inadequately treated mycobacterium tuberculosis (TB) infection.
9.Previous or current use of other immunomodulatory or immunosuppressive treatments except for permitted background medications specified in the protocol.
10. Inadequate organ function levels, including abnormalities in hematology, liver function, renal function, coagulation function, cardiac function, etc.
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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 | Not yet recruiting | Hefei | Anhui | 230022 | China |
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| ICP-488 Tablets |
| Drug |
Patients will receive ICP-488 orally as per the protocol |
|
| ICP-488 Placebo | Other | Patients will receive ICP-488 Placebo orally as per the protocol. |
|
| From baseline to week 28 |
| The average change of the CLASI-A score from the baseline value at each visit. | From baseline to week 28 |
| The percentage change of CLASI-A relative to the baseline at each visit. | From baseline to week 28 |
| Adverse events that occurred during treatment. | From baseline to week 28 |
| The incidence of clinical abnormalities such as laboratory test results, electrocardiogram (ECG), and vital signs, and the changes relative to the baseline. | From baseline to week 28 |
| Maximum Concentration at Steady State(Cmax,ss) | From baseline to week 12 |
| Steady-State Time to Maximum | From baseline to week 12 |
| Area under the curve (AUC) | From baseline to week 12 |
| Peking University First Hospital | Recruiting | Beijing | Beijing Municipality | 100034 | China |
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| Xuanwu Hospital Capital Medical University | Not yet recruiting | Beijing | Beijing Municipality | 100053 | China |
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| The First Affiliated Hospital of Chongqing Medical University | Not yet recruiting | Chongqing | Chongqing Municipality | 400010 | China |
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| Chongqing Hospital of Traditional Chinese Medicine | Not yet recruiting | Chongqing | Chongqing Municipality | 400021 | China |
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| The First Affiliated Hospital of Fujian Medical University | Not yet recruiting | Fuzhou | Fujian | 350005 | China |
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| Dongguan people's hospital | Recruiting | Dongguan | Guangdong | 523059 | China |
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| Dermatology Hospital of Southern Medical University | Recruiting | Guangzhou | Guangdong | 510091 | China |
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| Sun Yat-sen Memorial Hospital, Sun Yat-sen University | Recruiting | Guangzhou | Guangdong | 510120 | China |
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| The Second Hospital of Hebei Medical University | Not yet recruiting | Shijiazhuang | Hebei | China |
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| The First Affiliated Hospital of Zhengzhou University | Not yet recruiting | Zhengzhou | Henan | 450052 | China |
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| Jingzhou Central Hospital | Not yet recruiting | Jingzhou | Hubei | 434020 | China |
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| Affiliated Drum Tower Hospital, Medical School of Nanjing University | Not yet recruiting | Nanjing | Jiangsu | 210008 | China |
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| Hospital for Skin Diseases, Institute of Dermatology, Chinese Academy of Medical Sciences and Peking Union Medical College | Not yet recruiting | Nanjing | Jiangsu | Qianjin Lu | China |
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| The Second Affiliated Hospital of Soochow University | Recruiting | Suzhou | Jiangsu | 215004 | China |
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| Dermatology Hospital of Jiangxi Province | Recruiting | Nanchang | Jiangxi | 330000 | China |
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| The First AffiliatedHospital of China Medical University | Not yet recruiting | Shenyang | Liaoning | 110001 | China |
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| Jinan Central Hospital | Recruiting | Jinan | Shandong | 250013 | China |
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| Dermatology Hospital of Shandong First Medical University | Recruiting | Jinan | Shandong | 250022 | China |
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| Huashan Hospital Fudan University | Recruiting | Shanghai | Shanghai Municipality | 200040 | China |
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| Shanghai Skin Disease Hospital | Not yet recruiting | Shanghai | Shanghai Municipality | 200443 | China |
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| First Hospital of Shanxi Medical University | Not yet recruiting | Taiyuan | Shanxi | 030001 | China |
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| West China Hospital, Sichuan University | Not yet recruiting | Chengdu | Sichuan | 610041 | China |
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| Sichuan Provincial People's Hospital | Not yet recruiting | Chengdu | Sichuan | 610072 | China |
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| People's Hospital of Xinjiang Uygur Autonomous Region | Not yet recruiting | Ürümqi | Xinjiang Uygur Autonomous Region | 830001 | China |
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| The First Affiliated Hospital of Kunming Medical University | Recruiting | Kunming | Yunnan | 650032 | China |
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| Hangzhou Third people's Hospital | Not yet recruiting | Hangzhou | Zhejiang | 310009 | China |
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| ID | Term |
|---|---|
| D008178 | Lupus Erythematosus, Cutaneous |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |
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