Clinical trial NCT04643470: Zanubrutinib in Participants With Active Proliferative Lupus Nephritis
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lupus Nephritis
Lead sponsor: BeiGene
Sponsor class: INDUSTRY
First posted: 2020-11-25
Enrollment: 177
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: Key Inclusion Criteria:

1. Clinical diagnosis of SLE according to the Systemic Lupus International Collaborating Clinics 2012 criteria.
2. 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.
3. Positive antinuclear antibodies, positive anti-dsDNA autoantibody, and/or positive anti Smith autoantibody at screening
4. Has 24-hour urine protein excretion \> 1.0 g at screening.

Key Exclusion Criteria:

Exclusion criteria related to systemic lupus erythematous and other diseases:

1. Glomerulonephritis caused by reasons other than systemic lupus erythematous.
2. Sclerosis in \>50% of glomeruli on renal biopsy.
3. Any other inflammatory diseases that might confound the assessments of efficacy, including but not limited to rheumatoid arthritis, myositis, vasculitis, or overlapping syndrome.
4. 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.

Primary outcomes:
measure: Proportion of participants with complete renal response
timeFrame: Week 49 Day 1
Secondary outcomes:
measure: Proportion of participants achieving complete renal response
timeFrame: Up to Week 73 Day 1
measure: Proportion of participants achieving partial renal response
timeFrame: Up to Week 73 Day 1
measure: Proportion of participants achieving overall renal response
timeFrame: Up to Week 73 Day 1
measure: Time to first complete renal response
timeFrame: Up to Week 73 Day 1
measure: Time to first overall renal response
timeFrame: Up to Week 73 Day 1
measure: Change in total Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score
timeFrame: Baseline to Week 49 Day 1
measure: Area under plasma concentration time curve (AUC) of zanubrutinib
timeFrame: Week 1 Day 1 and Week 5 Day 1
Other outcomes:
Locations:
city: Hefei
country: China
facility: Anhui Provincial Hospital
state: Anhui
city: Beijing
country: China
facility: Peking University Peoples Hospital
state: Beijing
city: Beijing
country: China
facility: Peking University International Hospital
state: Beijing
city: Xiamen
country: China
facility: The First Affiliated Hospital of Xiamen University
state: Fujian
city: Xiamen
country: China
facility: Zhongshan Hospital Xiamen University
state: Fujian
city: Guangzhou
country: China
facility: Sun Yat Sen Memorial Hospital, Sun Yat Sen University (North)
state: Guangdong
city: Guangzhou
country: China
facility: Guangdong Provincial Peoples Hospital
state: Guangdong
city: Guangzhou
country: China
facility: The First Affiliated Hospital, Sun Yat Sen University
state: Guangdong
city: Guangzhou
country: China
facility: The Third Affiliated Hospital, Sun Yat Sen University
state: Guangdong
city: Guangzhou
country: China
facility: Guangdong Province Traditional Chinese Medical Hospitsal
state: Guangdong
city: Jiangmen
country: China
facility: Jiangmen Central Hospital
state: Guangdong
city: Shenzhen
country: China
facility: Peking University Shenzhen Hospital
state: Guangdong
city: Shenzhen
country: China
facility: The Second Peoples Hospital of Shenzhen
state: Guangdong
city: Liuzhou
country: China
facility: Liuzhou Workers Hospital
state: Guangxi
city: Nanning
country: China
facility: The Peoples Hospital of Guangxi Zhuang Autonomous Region
state: Guangxi
city: Guiyang
country: China
facility: Guizhou Provincial Peoples Hospital
state: Guizhou
city: Haikou
country: China
facility: Hainan General Hospital
state: Hainan
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
state: Henan
city: Wuhan
country: China
facility: Renmin Hospital of Wuhan University
state: Hubei
city: Changsha
country: China
facility: The Second Xiangya Hospital of Central South University
state: Hunan
city: Nanjing
country: China
facility: General Hospital of Eastern Theater Command
state: Jiangsu
city: Nanjing
country: China
facility: Jiangsu Province Hospital
state: Jiangsu
city: Wuxi
country: China
facility: Wuxi Peoples Hospital
state: Jiangsu
city: Xuzhou
country: China
facility: The Affiliated Hospital of Xuzhou Medical University
state: Jiangsu
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University Branch Donghu
state: Jiangxi
city: Nanchang
country: China
facility: The Second Affiliated Hospital of Nanchang University
state: Jiangxi
city: Changchun
country: China
facility: The Second Hospital of Jilin University
state: Jilin
city: Dalian
country: China
facility: First Affiliated Hospital of Dalian Medical University
state: Liaoning
city: Shenyang
country: China
facility: Shengjing Hospital of China Medical University
state: Liaoning
city: Yinchuan
country: China
facility: General Hospital of Ningxia Medical University
state: Ningxia
city: Xian
country: China
facility: The Second Affiliated Hospital of Xian Jiaotong University
state: Shaanxi
city: Xian
country: China
facility: The First Affiliated Hospital of Xian Jiaotong University
state: Shaanxi
city: Jinan
country: China
facility: Shandong Provincial Hospital
state: Shandong
city: Qingdao
country: China
facility: The Affiliated Hospital of Qingdao University Branch South
state: Shandong
city: Shanghai
country: China
facility: Huashan Hospital Affiliated to Fudan University
state: Shanghai
city: Shanghai
country: China
facility: Shanghai General Hospital
state: Shanghai
city: Taiyuan
country: China
facility: Second Hospital of Shanxi Medical University
state: Shanxi
city: Chengdu
country: China
facility: West China Hospital, Sichuan University
state: Sichuan
city: Chengdu
country: China
facility: Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital
state: Sichuan
city: Tianjin
country: China
facility: The Second Affiliated Hospital of Tianjin Medical University
state: Tianjin
city: Urumqi
country: China
facility: The First Affiliated Hospital of Xinjiang Medical University
state: Xinjiang
city: Kunming
country: China
facility: First Affiliated Hospital of Kunming Medical University
state: Yunnan
city: Hangzhou
country: China
facility: The First Affiliated Hospital, Zhejiang University School of Medicine
state: Zhejiang
city: Ningbo
country: China
facility: Ningbo First Hospital
state: Zhejiang
Study officials:
affiliation: BeiGene
name: Zhen Yao, MD
role: STUDY_DIRECTOR
References: