Date

2024-12-18

Protocol

Protocol changed

Item Changed

Exclusion criteria

Previous Version

• IgAN secondary to another condition (e.g., liver cirrhosis), or other causes of mesangial IgA deposition including IgA vasculitis (i.e., Henoch-Schonlein purpura), systemic lupus erythematosus (SLE), dermatitis herpetiformis, ankylosing spondylitis. • Total urine protein excretion greater than or equal to 5g per 24-hour or urine protein to creatinine ratio (UPCR) greater than or equal to 5 mg/mg based on a 24-hour urine sample during the Screening Period • Evidence of rapidly progressive glomerulonephritis (loss of greater than or equal to 50% of eGFR within 3 months of screening) • Evidence of nephrotic syndrome within 6 months of screening (serum albumin <30g/L in association with UPCR >3.5 mg/mg • Renal or other organ transplantation prior to or expected during the study. • Concomitant chronic renal disease in addition to IgAN • Uncontrolled diabetes, defined as hemoglobin-A1c (HbA1c) >7.5% at screening. • History of tuberculosis (TB), untreated latent TB infection (LTBI), or evidence of active TB determined by a positive Quantiferon test. • Participation in the Phase 2b (Parts A and B) study or any previous treatment with atacicept

Next Version

1. Participation in the Phase 2b (Parts A and B) study or any previous treatment with atacicept. 2. IgAN secondary to another condition (e.g., liver cirrhosis), or other causes of mesangial IgA deposition including IgA vasculitis (i.e., Henoch-Schonlein purpura), systemic lupus erythematosus (SLE), dermatitis herpetiformis, ankylosing spondylitis 3. Evidence of rapidly progressive glomerulonephritis (loss of ? 50% of eGFR within 3 months of screening) 4. Total urine protein excretion ?5g per 24-hour or urine protein to creatinine ratio (UPCR) ?5 mg/mg based on a 24-hour urine sample during the Screening Period 5. Evidence of nephrotic syndrome within 6 months of screening (serum albumin 3.5 mg/mg) 6. Renal or other organ transplantation prior to, or expected during, the study, with the exception of corneal transplants 7. Concomitant chronic renal disease in addition to IgAN (e.g., diabetic nephropathy, primary focal segmental glomerulosclerosis (FSGS), membranous nephropathy, C3 glomerulopathy, lupus nephritis) 8. Uncontrolled diabetes, defined as hemoglobin-A1c (HbA1c) >7.5% at screening 9. History of tuberculosis (TB), untreated latent TB infection (LTBI), or evidence of active TB determined by a positive Quantiferon test at the Screening Visit.