The BRIGHT-SC study is designed to evaluate the efficacy and safety of subcutaneous blisibimod compared with placebo in patients with biopsy-proven IgA Nephropathy. Patients aged 18-65 years with biopsy proven IgAN and persistent proteinuria >1g/24hrs but <6g/24hrs during a 2-6 week period prior to enrollment are randomized to receive either blisibimod (300mg /wk for 8 weeks and 200mg/wk thereafter) or matching placebo over background angiotensin converting enzyme inhibitor (ACEi) or angiotensin receptor blocker (ARB). All patients are treated with an optimal dose of ACEi or ARB for a minimum of 90 days prior to randomization. Patients exposed to corticosteroids within 3 months of randomization are excluded. Efficacy will be assessed for treatment response as well as changes in proteinuria and eGFR. A partial response is defined as patients achieving proteinuria ≤1g/24hrs at Week 24. A complete response response is defined as follows: for subjects with baseline proteinuria ≥1g/24hrs but ≤2g/24hrs, achievement of proteinuria ≤1.0g/24hr AND a 50% reduction from baseline at 2 consecutive visits; for subjects with baseline proteinuria >2g/24hrs, achievement of proteinuria ≤1.0g/24hr OR a 50% reduction from baseline at 2 consecutive visits. The study is being conducted in Asia and Europe.
STATUS: 6 Month data available, 12 month data in Q4 16
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