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)
🇨🇳Guangzhou, Guangdong, China
The Third Affiliated Hospital, Sun Yat Sen University
🇨🇳Guangzhou, Guangdong, China
Guangdong Province Traditional Chinese Medical Hospitsal
🇨🇳Guangzhou, Guangdong, China
Guizhou Provincial Peoples Hospital
🇨🇳Guiyang, Guizhou, China
Hainan General Hospital
🇨🇳Haikou, Hainan, China
Jiangsu Province Hospital
🇨🇳Nanjing, Jiangsu, China
Shengjing Hospital of China Medical University
🇨🇳Shenyang, Liaoning, China
Shanghai General Hospital
🇨🇳Shanghai, Shanghai, China
The First Affiliated Hospital of Xinjiang Medical University
🇨🇳Urumqi, Xinjiang, China
Anhui Provincial Hospital
🇨🇳Hefei, Anhui, China
Scroll for more (34 remaining)Sun Yat Sen Memorial Hospital, Sun Yat Sen University (North)🇨🇳Guangzhou, Guangdong, China