Zanubrutinib in Participants With Active Proliferative Lupus Nephritis
A Phase 2, Multicenter, Randomized, Double Blind, Placebo Controlled Study to Evaluate the Safety and Efficacy of Zanubrutinib in Patients With Active Proliferative Lupus Nephritis
2 other identifiers
interventional
177
1 country
44
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 2020
Typical duration for phase_2
44 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 18, 2020
CompletedFirst Posted
Study publicly available on registry
November 25, 2020
CompletedStudy Start
First participant enrolled
December 22, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 26, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
August 26, 2024
CompletedNovember 29, 2024
November 1, 2024
3.2 years
November 18, 2020
November 27, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Proportion of participants with complete renal response
Week 49 Day 1
Secondary Outcomes (7)
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
Proportion of participants achieving overall renal response
Up to Week 73 Day 1
Time to first complete renal response
Up to Week 73 Day 1
Time to first overall renal response
Up to Week 73 Day 1
- +2 more secondary outcomes
Study Arms (4)
Zanubrutinib Low Dose
EXPERIMENTALParticipants will receive zanubrutinib 40 mg twice daily (BID) for 72 weeks
Zanubrutinib High Dose
EXPERIMENTALParticipants will receive zanubrutinib 160 mg twice daily (BID) for 72 weeks
Zanubrutinib Medium Dose
EXPERIMENTALParticipants will receive zanubrutinib 160 mg once daily (QD) for 72 weeks
Placebo
EXPERIMENTALParticipants will receive placebo to match zanubrutinib for 72 weeks
Interventions
Administered as specified in the treatment arm
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- BeiGenelead
Study Sites (44)
Anhui Provincial Hospital
Hefei, Anhui, 230000, China
Peking University Peoples Hospital
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
Liuchow, 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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Zhen Yao, MD
BeiGene
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 18, 2020
First Posted
November 25, 2020
Study Start
December 22, 2020
Primary Completion
February 26, 2024
Study Completion
August 26, 2024
Last Updated
November 29, 2024
Record last verified: 2024-11
Data Sharing
- IPD Sharing
- Will share