Zanubrutinib in Participants With Active Proliferative Lupus Nephritis
- Registration Number
- NCT04643470
- Lead Sponsor
- BeiGene
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 177
- Clinical diagnosis of SLE according to the Systemic Lupus International Collaborating Clinics 2012 criteria.
- ISN/RPS 2003 Class III/IV lupus nephritis [Type III(A), III (A+C), IV (A), and IV (A+C)], with or without Class V, as confirmed by a renal biopsy.
- Positive antinuclear antibodies, positive anti-dsDNA autoantibody, and/or positive anti Smith autoantibody at screening
- Has 24-hour urine protein excretion > 1.0 g at screening.
Key
Exclusion criteria related to systemic lupus erythematous and other diseases:
- Glomerulonephritis caused by reasons other than systemic lupus erythematous.
- Sclerosis in >50% of glomeruli on renal biopsy.
- Any other inflammatory diseases that might confound the assessments of efficacy, including but not limited to rheumatoid arthritis, myositis, vasculitis, or overlapping syndrome.
- Severe extrarenal SLE, including but not limited to severe pulmonary arterial hypertension, severe myocarditis, severe central nervous system lupus (such as neuropsychiatric SLE, seizures, psychosis, transverse myelitis, central nervous system vasculitis and optic neuritis), etc.
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Participants will receive placebo to match zanubrutinib for 72 weeks Zanubrutinib Low Dose Zanubrutinib Participants will receive zanubrutinib 40 mg twice daily (BID) for 72 weeks Zanubrutinib Medium Dose Zanubrutinib Participants will receive zanubrutinib 160 mg once daily (QD) for 72 weeks Zanubrutinib High Dose Zanubrutinib Participants will receive zanubrutinib 160 mg twice daily (BID) for 72 weeks
- Primary Outcome Measures
Name Time Method Proportion of participants with complete renal response Week 49 Day 1
- Secondary Outcome Measures
Name Time Method Proportion of participants achieving complete renal response Up to Week 73 Day 1 Proportion of participants achieving overall renal response Up to Week 73 Day 1 Time to first overall renal response Up to Week 73 Day 1 The time from the date of randomization to the date of the first overall renal response
Proportion of participants achieving partial renal response Up to Week 73 Day 1 Time to first complete renal response Up to Week 73 Day 1 The time from the date of randomization to the date of the first complete renal response
Change in total Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score Baseline to Week 49 Day 1 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
Area under plasma concentration time curve (AUC) of zanubrutinib Week 1 Day 1 and Week 5 Day 1
Trial Locations
- Locations (44)
Sun Yat Sen Memorial Hospital, Sun Yat Sen University (North)
π¨π³Guangzhou, Guangdong, China
Jiangsu Province Hospital
π¨π³Nanjing, Jiangsu, China
Shengjing Hospital of China Medical University
π¨π³Shenyang, Liaoning, China
The Third Affiliated Hospital, Sun Yat Sen University
π¨π³Guangzhou, Guangdong, China
Guangdong Province Traditional Chinese Medical Hospitsal
π¨π³Guangzhou, Guangdong, China
Shanghai General Hospital
π¨π³Shanghai, Shanghai, China
The First Affiliated Hospital of Xinjiang Medical University
π¨π³Urumqi, Xinjiang, China
Anhui Provincial Hospital
π¨π³Hefei, Anhui, China
Peking University Peoples Hospital
π¨π³Beijing, Beijing, China
Guizhou Provincial Peoples Hospital
π¨π³Guiyang, Guizhou, China
Peking University International Hospital
π¨π³Beijing, Beijing, China
The First Affiliated Hospital of Xiamen University
π¨π³Xiamen, Fujian, China
Zhongshan Hospital Xiamen University
π¨π³Xiamen, Fujian, China
Guangdong Provincial Peoples Hospital
π¨π³Guangzhou, Guangdong, China
The First Affiliated Hospital, Sun Yat Sen University
π¨π³Guangzhou, Guangdong, China
Jiangmen Central Hospital
π¨π³Jiangmen, Guangdong, China
Peking University Shenzhen Hospital
π¨π³Shenzhen, Guangdong, China
The Second Peoples Hospital of Shenzhen
π¨π³Shenzhen, Guangdong, China
Liuzhou Workers Hospital
π¨π³Liuzhou, Guangxi, China
The Peoples Hospital of Guangxi Zhuang Autonomous Region
π¨π³Nanning, Guangxi, China
The First Affiliated Hospital of Zhengzhou University
π¨π³Zhengzhou, Henan, China
Hainan General Hospital
π¨π³Haikou, Hainan, China
Renmin Hospital of Wuhan University
π¨π³Wuhan, Hubei, China
The Second Xiangya Hospital of Central South University
π¨π³Changsha, Hunan, China
General Hospital of Eastern Theater Command
π¨π³Nanjing, Jiangsu, China
Wuxi Peoples Hospital
π¨π³Wuxi, Jiangsu, China
The First Affiliated Hospital of Nanchang University Branch Donghu
π¨π³Nanchang, Jiangxi, China
The Affiliated Hospital of Xuzhou Medical University
π¨π³Xuzhou, Jiangsu, China
The Second Affiliated Hospital of Nanchang University
π¨π³Nanchang, Jiangxi, China
The Second Hospital of Jilin University
π¨π³Changchun, Jilin, China
First Affiliated Hospital of Dalian Medical University
π¨π³Dalian, Liaoning, China
General Hospital of Ningxia Medical University
π¨π³Yinchuan, Ningxia, China
Second Hospital of Shanxi Medical University
π¨π³Taiyuan, Shanxi, China
The Second Affiliated Hospital of Xian Jiaotong University
π¨π³Xian, Shaanxi, China
The First Affiliated Hospital of Xian Jiaotong University
π¨π³Xian, Shaanxi, China
Shandong Provincial Hospital
π¨π³Jinan, Shandong, China
The Affiliated Hospital of Qingdao University Branch South
π¨π³Qingdao, Shandong, China
Huashan Hospital Affiliated to Fudan University
π¨π³Shanghai, Shanghai, China
West China Hospital, Sichuan University
π¨π³Chengdu, Sichuan, China
Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital
π¨π³Chengdu, Sichuan, China
The Second Affiliated Hospital of Tianjin Medical University
π¨π³Tianjin, Tianjin, China
First Affiliated Hospital of Kunming Medical University
π¨π³Kunming, Yunnan, China
The First Affiliated Hospital, Zhejiang University School of Medicine
π¨π³Hangzhou, Zhejiang, China
Ningbo First Hospital
π¨π³Ningbo, Zhejiang, China