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| Name | Class |
|---|---|
| Zai Lab (Shanghai) Co., Ltd. | INDUSTRY |
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The purpose of the study is to evaluate the efficacy and safety of efgartigimod IV in Chinese patients with active lupus nephritis (LN). The study comprises an approximate 4-week screening period, a 24-week treatment period, and an 8-week follow- up period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| efgartigimod IV | Experimental | Patients receiving intravenous (IV) infusions of efgartigimod |
|
| Placebo | Placebo Comparator | Patients receiving intravenous (IV) infusions of placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| efgartigimod IV | Biological | Intravenous (IV) infusion of efgartigimod |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline to week 24 in urine protein creatinine ratio (UPCR) | up to 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants achieving complete renal response (CRR) at week 24 | up to 24 weeks | |
| Time to complete renal response (CRR) | up to 32 weeks | |
| Proportion of participants achieving partial renal response at week 24 |
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Inclusion Criteria:
Exclusion Criteria:
The full list of criteria can be found in the protocol.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Third Hospital | Beijing | 100191 | China | |||
| Peking University People's Hospital |
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| Placebo |
| Other |
Intravenous (IV) infusion of placebo |
|
| up to 24 weeks |
| Time to partial renal response (PRR) | up to 24 weeks |
| Change from baseline to week 24 in estimated glomerular filtration rate (eGFR) | up to 24 weeks |
| Change from baseline to week 24 in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI)-2K score | up to 24 weeks |
| Change from baseline to week 24 in the dosage of glucocorticoids | up to 24 weeks |
| Treatment failure rate during treatment period | up to 24 weeks |
| Proportion of participants achieving modified complete renal response (mCRR) at week 24 | up to 24 weeks |
| Efgartigimod serum concentration-time profile | up to 32 weeks |
| Changes from baseline in levels of total IgG | up to 32 weeks |
| Incidence of ADA against efgartigimod | up to 32 weeks |
| Median changes in concentration from baseline over time in biomarkers (Anti-dsDNA, C3, C4 and CH50) | (all have the same measuring units) | up to 32 weeks |
| Change from baseline to week 24 in EuroQoL 5-Dimension 5-Level (EQ-5D-5L) score | Up to 24 weeks |
| Beijing |
| China |
| Hunan Provincial People's Hospital | Changsha | China |
| The Second Affiliated Hospital of Chongqing Medical University | Chongqing | China |
| Fujian Medical University Union Hospital | Fujian | China |
| Guangdong Provincial People's Hospital | Guangzhou | China |
| Sun Yat-sen Memorial Hospital, Sun Yat-sen University | Guangzhou | China |
| The First Affiliated Hospital,Sun Yat-sen University | Guanzhou | China |
| The First Affiliated Hospital, Zhejiang University | Hangzhou | China |
| First Affiliated Hospital of University of South China | Hengyang | China |
| The Affiliated Huaian No.1 People's Hospital of Nanjing Medical University | Huainan | China |
| Jieyang People's Hospital | Jieyang | 522091 | China |
| Shandong Provincial Hospital Affiliated to Shandong First Medical University | Jinan | China |
| Affiliated Hospital of Jining Medical University | Jining | China |
| Liu Zhou Works Hospital | Liuzhou | China |
| Jiangxi Provincial People's Hospital | Nanchang | 330006 | China |
| The First Affiliated Hospital of Nanchang University | Nanchang | China |
| Jiangsu Province Hospital | Nanjing | China |
| Zhongda Hospital Southeast University | Nanjing | China |
| The People's Hospital of Guangxi Zhuang Autonomous Region | Nanning | China |
| Huashan Hospital Fudan University | Shanghai | China |
| ShengJing Hospital of China Medical University | Shenyang | China |
| Shenzhen People's Hospital | Shenzhen | China |
| The First Hospital of Hebei Medical University | Shijia Zhuang | China |
| The Second Hospital of Tianjin Medical University | Tianjin | China |
| Renmin Hospital of Wuhan University | Wuhan | China |
| Wuxi People's Hospital | Wuxi | China |
| Shaanxi Provincial Hospital of Chinese Medicine | Xi'an | China |
| The First Affiliated Hospital of Xiamen University | Xiamen | China |
| The First Affiliated Hospital of Zhengzhou University | Zhengzhou | 310058 | China |
| Henan Provincial People's Hospital | Zhengzhou | China |
| ID | Term |
|---|---|
| D008181 | Lupus Nephritis |
| D009393 | Nephritis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D005921 | Glomerulonephritis |
| ID | Term |
|---|---|
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D008180 | Lupus Erythematosus, Systemic |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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