Lupus Nephritis
Conditions
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
Interventions
DRUGZanubrutinib
Administered as specified in the treatment arm
DRUGPlacebo
Placebo to match zanubrutinib
Sponsors
BeiGene
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: 1. Clinical diagnosis of SLE according to the Systemic Lupus International Collaborating Clinics 2012 criteria. 2. 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. 3. Positive antinuclear antibodies, positive anti-dsDNA autoantibody, and/or positive anti Smith autoantibody at screening 4. Has 24-hour urine protein excretion \> 1.0 g at screening. Key
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of participants with complete renal response | Week 49 Day 1 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of participants achieving partial renal response | Up to Week 73 Day 1 | — |
| Proportion of participants achieving overall 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 |
| Proportion of participants achieving complete renal response | Up to Week 73 Day 1 | — |
| 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 | — |
| 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 |
Countries
China
Outcome results
None listed