A Phase 2 interventional study of Zanubrutinib and Placebo in Lupus Nephritis, sponsored by BeiGene. Completed at 44 sites in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-11-29.
Sponsored by BeiGene · Phase 2, Interventional, and Treatment
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
245 studies on the registry are indexed under Nephritis; 56 are open to participants now.
This study's enrollment of 177 is above the median of 49 across 156 interventional studies indexed under Nephritis.
Browse Nephritis studies →BeiGene is the lead sponsor of 122 studies on the registry; 3 are open to participants now.
Of its 52 completed or terminated interventional studies of FDA-regulated products, 31 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
Exclusion criteria related to systemic lupus erythematous and other diseases:
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Participants will receive zanubrutinib 40 mg twice daily (BID) for 72 weeks
Drug: Zanubrutinib
Participants will receive zanubrutinib 160 mg twice daily (BID) for 72 weeks
Drug: Zanubrutinib
Participants will receive zanubrutinib 160 mg once daily (QD) for 72 weeks
Drug: Zanubrutinib
Participants will receive placebo to match zanubrutinib for 72 weeks
Drug: Placebo
Administered as specified in the treatment arm
Also known as: BGB-3111, Brukinsa
Placebo to match zanubrutinib
Proportion of participants with complete renal response
Time frame: Week 49 Day 1
Proportion of participants achieving complete renal response
Time frame: Up to Week 73 Day 1
Proportion of participants achieving partial renal response
Time frame: Up to Week 73 Day 1
Proportion of participants achieving overall renal response
Time frame: Up to Week 73 Day 1
Time to first complete renal response
The time from the date of randomization to the date of the first complete renal response
Time frame: Up to Week 73 Day 1
Time to first overall renal response
The time from the date of randomization to the date of the first overall renal response
Time frame: Up to Week 73 Day 1
Change in total Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score
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
Time frame: Baseline to Week 49 Day 1
Area under plasma concentration time curve (AUC) of zanubrutinib
Time frame: Week 1 Day 1 and Week 5 Day 1
Plan to share: Yes
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This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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