Zanubrutinib
DrugAdministered as specified in the treatment arm
Other names: BGB-3111, Brukinsa
NCT Number: NCT04643470
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
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Notify Me18 year–70 year
All sexes
Interventional
Phase 2
Anhui Provincial Hospital, Hefei, Anhui, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Administered as specified in the treatment arm
Other names: BGB-3111, Brukinsa
Placebo to match zanubrutinib
Time frame: Week 49 Day 1
Time frame: Up to Week 73 Day 1
Time frame: Up to Week 73 Day 1
Time frame: Up to Week 73 Day 1
Time frame: Up to Week 73 Day 1
The time from the date of randomization to the date of the first complete renal response
Time frame: Up to Week 73 Day 1
The time from the date of randomization to the date of the first overall renal response
Time frame: 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
Time frame: Week 1 Day 1 and Week 5 Day 1
BeiGene
Industry
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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