Zanubrutinib in Participants With Active Proliferative Lupus Nephritis

  • End date
    Aug 5, 2023
  • participants needed
  • sponsor
Updated on 5 May 2022
24-hour urine protein test


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

Condition Lupus Nephritis
Treatment Placebo, Zanubrutinib
Clinical Study IdentifierNCT04643470
Last Modified on5 May 2022


Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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 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
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