The objective of the study is to evaluate the effect of atacicept compared to placebo on changes to renal response in adult subjects with LN.
The study will assess atacicept vs. placebo on the impact of renal function. Safety and patient reported outcomes will be clinically assessed. The clinical study is comprised of a 104 week double-blind treatment period, followed by a 52 week open-label treatment period and a 26 week safety follow-up period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Renal Response as definedas UPCR ≤0.5 mg/mg, and eGFR ≥60 mL/min/1.73 m^2 or eGFR <60 mL/min/1.73 m^2 with no confirmed decrease from baseline of >20%
Time frame: Week 52
Renal Response with alternative success criteria
Time frame: Weeks 52 and 104
Time to UPCR of≤0.5 mg/mg
Time frame: Week 52
Renal Response at Week 104
Time frame: Week 104
Time to Death or Renal-Related Event
Time frame: Week 104
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Vera Site # 0139
Huntsville, Alabama, United States
Vera Site # 0138
La Jolla, California, United States
Vera Site # 0127
La Palma, California, United States
Vera Site # 0129
Long Beach, California, United States
Vera Site # 0135
Northridge, California, United States
Vera Site # 0136
Northridge, California, United States
Vera Site # 0130
Santa Clarita, California, United States
Vera Site # 0131
Torrance, California, United States
Vera Site # 0143
New Haven, Connecticut, United States
Vera Site # 0140
Gainesville, Florida, United States
...and 23 more locations