To demonstrate the efficacy of SHR-1314 at Week 12 in subjects with proliferation lupus nephritis in terms of improvement of 24h UPCR, compared to placebo. The study will also assess the safety and tolerability of SHR-1314 in the patient population over the study period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
60
percentage change of 24 hours UPCR from baseline to Week 12.
Time frame: at 12 weeks
Percentage change of 24 hours UPCR from baseline to Week 24
Time frame: from baseline to Week 24
Percentage change of 24 hours UPCR from Week 12 to Week24
Time frame: from Week 12 to Week24
Percentage of participants achieving 24h UPCR <0.5 g/g at Week 12 and Week 24
Time frame: at Week 12 and Week 24
Percentage of participants achieving renal Complete Response at Week 12 and Week 24
Time frame: at Week 12 and Week 24
Percentage of pts achieving renal Partial Response at Week 12 and Week 24
Time frame: at Week 12 and Week 24
Change in PGA from baseline to Week 12 and Week 24
Time frame: from baseline to Week 12 and Week 24
Change in SLEDAI-2K from baseline to Week 12 and Week 24
Time frame: from baseline to Week 12 and Week 24
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