CompletedPhase 2

Zanubrutinib in Participants With Active Proliferative Lupus Nephritis

China177 participantsStarted 2020-12-22

Plain-language 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

Who can participate

Age range18 Years – 70 Years

SexALL

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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

✕. 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.

What they're measuring

Proportion of participants with complete renal response

Timeframe: Week 49 Day 1

Trial details

NCT IDNCT04643470

SponsorBeiGene

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-02-26

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