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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
177
Administered as specified in the treatment arm
Placebo to match zanubrutinib
Proportion of participants with complete renal response
Time frame: Week 49 Day 1
Proportion of participants achieving complete renal response
Time frame: Up to Week 73 Day 1
Proportion of participants achieving partial renal response
Time frame: Up to Week 73 Day 1
Proportion of participants achieving overall renal response
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline to Week 49 Day 1
Area under plasma concentration time curve (AUC) of zanubrutinib
Time frame: Week 1 Day 1 and Week 5 Day 1
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Anhui Provincial Hospital
Hefei, Anhui, China
Peking University Peoples Hospital
Beijing, Beijing Municipality, China
Peking University International Hospital
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
Zhongshan Hospital Xiamen University
Xiamen, Fujian, China
Sun Yat Sen Memorial Hospital, Sun Yat Sen University (North)
Guangzhou, Guangdong, China
Guangdong Provincial Peoples Hospital
Guangzhou, Guangdong, China
The First Affiliated Hospital, Sun Yat Sen University
Guangzhou, Guangdong, China
The Third Affiliated Hospital, Sun Yat Sen University
Guangzhou, Guangdong, China
Guangdong Province Traditional Chinese Medical Hospitsal
Guangzhou, Guangdong, China
...and 34 more locations