Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| CTR20202662 | Other Identifier | ChinaDrugTrials |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The primary objective of this study is to evaluate the efficacy of zanubrutinib added to standard of care as measured by complete renal response for participants with active proliferative lupus nephritis
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zanubrutinib Low Dose | Experimental | Participants will receive zanubrutinib 40 mg twice daily (BID) for 72 weeks |
|
| Zanubrutinib High Dose | Experimental | Participants will receive zanubrutinib 160 mg twice daily (BID) for 72 weeks |
|
| Zanubrutinib Medium Dose | Experimental | Participants will receive zanubrutinib 160 mg once daily (QD) for 72 weeks |
|
| Placebo | Experimental | Participants will receive placebo to match zanubrutinib for 72 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zanubrutinib | Drug | Administered as specified in the treatment arm |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants with complete renal response | Week 49 Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants achieving complete renal response | Up to Week 73 Day 1 | |
| Proportion of participants achieving partial renal response | Up to Week 73 Day 1 | |
Not provided
Key Inclusion Criteria:
Key Exclusion Criteria:
Exclusion criteria related to systemic lupus erythematous and other diseases:
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Zhen Yao, MD | BeiGene | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anhui Provincial Hospital | Hefei | Anhui | 230000 | China | ||
| Peking University Peoples Hospital |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Placebo | Drug | Placebo to match zanubrutinib |
|
| Proportion of participants achieving overall renal response |
| Up to Week 73 Day 1 |
| Time to first complete renal response | The time from the date of randomization to the date of the first complete renal response | Up to Week 73 Day 1 |
| Time to first overall renal response | The time from the date of randomization to the date of the first overall renal response | Up to Week 73 Day 1 |
| Change in total Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score | SLEDAI-2K score is a systemic lupus erythematosus (SLE) activity index based on the presence of 24 features in 9 organ systems which ranges from 0 - 105, with higher scores indicating more severe features in participants in the past 30 days | Baseline to Week 49 Day 1 |
| Area under plasma concentration time curve (AUC) of zanubrutinib | Week 1 Day 1 and Week 5 Day 1 |
| Beijing |
| Beijing Municipality |
| 100044 |
| China |
| Peking University International Hospital | Beijing | Beijing Municipality | 102206 | China |
| The First Affiliated Hospital of Xiamen University | Xiamen | Fujian | 361003 | China |
| Zhongshan Hospital Xiamen University | Xiamen | Fujian | 361004 | China |
| Sun Yat Sen Memorial Hospital, Sun Yat Sen University (North) | Guangzhou | Guangdong | 510000 | China |
| Guangdong Provincial Peoples Hospital | Guangzhou | Guangdong | 510080 | China |
| The First Affiliated Hospital, Sun Yat Sen University | Guangzhou | Guangdong | 510080 | China |
| The Third Affiliated Hospital, Sun Yat Sen University | Guangzhou | Guangdong | 510630 | China |
| Guangdong Province Traditional Chinese Medical Hospitsal | Guangzhou | Guangdong | 510655 | China |
| Jiangmen Central Hospital | Jiangmen | Guangdong | 529030 | China |
| Peking University Shenzhen Hospital | Shenzhen | Guangdong | 518036 | China |
| The Second Peoples Hospital of Shenzhen | Shenzhen | Guangdong | 518037 | China |
| Liuzhou Workers Hospital | Liuzhou | Guangxi | 545005 | China |
| The Peoples Hospital of Guangxi Zhuang Autonomous Region | Nanning | Guangxi | 530021 | China |
| Guizhou Provincial Peoples Hospital | Guiyang | Guizhou | 550002 | China |
| Hainan General Hospital | Haikou | Hainan | 570206 | China |
| The First Affiliated Hospital of Zhengzhou University | Zhengzhou | Henan | 450052 | China |
| Renmin Hospital of Wuhan University | Wuhan | Hubei | 430060 | China |
| The Second Xiangya Hospital of Central South University | Changsha | Hunan | 410011 | China |
| General Hospital of Eastern Theater Command | Nanjing | Jiangsu | 210002 | China |
| Jiangsu Province Hospital | Nanjing | Jiangsu | 210029 | China |
| Wuxi Peoples Hospital | Wuxi | Jiangsu | 214023 | China |
| The Affiliated Hospital of Xuzhou Medical University | Xuzhou | Jiangsu | 221000 | China |
| The First Affiliated Hospital of Nanchang University Branch Donghu | Nanchang | Jiangxi | 330006 | China |
| The Second Affiliated Hospital of Nanchang University | Nanchang | Jiangxi | 330006 | China |
| The Second Hospital of Jilin University | Changchun | Jilin | 130022 | China |
| First Affiliated Hospital of Dalian Medical University | Dalian | Liaoning | 116011 | China |
| Shengjing Hospital of China Medical University | Shenyang | Liaoning | 110004 | China |
| General Hospital of Ningxia Medical University | Yinchuan | Ningxia | 750004 | China |
| The Second Affiliated Hospital of Xian Jiaotong University | Xi'an | Shaanxi | 710004 | China |
| The First Affiliated Hospital of Xian Jiaotong University | Xi'an | Shaanxi | 710061 | China |
| Shandong Provincial Hospital | Jinan | Shandong | 250021 | China |
| The Affiliated Hospital of Qingdao University Branch South | Qingdao | Shandong | 266000 | China |
| Huashan Hospital Affiliated to Fudan University | Shanghai | Shanghai Municipality | 200040 | China |
| Shanghai General Hospital | Shanghai | Shanghai Municipality | 200080 | China |
| Second Hospital of Shanxi Medical University | Taiyuan | Shanxi | 030001 | China |
| West China Hospital, Sichuan University | Chengdu | Sichuan | 610041 | China |
| Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital | Chengdu | Sichuan | 610071 | China |
| The Second Affiliated Hospital of Tianjin Medical University | Tianjin | Tianjin Municipality | 300000 | China |
| The First Affiliated Hospital of Xinjiang Medical University | Ürümqi | Xinjiang | 830054 | China |
| First Affiliated Hospital of Kunming Medical University | Kunming | Yunnan | 650032 | China |
| The First Affiliated Hospital, Zhejiang University School of Medicine | Hangzhou | Zhejiang | 310003 | China |
| Ningbo First Hospital | Ningbo | Zhejiang | 315010 | China |
| ID | Term |
|---|---|
| D008181 | Lupus Nephritis |
| ID | Term |
|---|---|
| D005921 | Glomerulonephritis |
| D009393 | Nephritis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| C000629551 | zanubrutinib |
Not provided
Not provided
Not provided