The overall purpose of this two-part study is to evaluate the efficacy, safety and tolerability of iptacopan (LNP023) in addition to standard of care treatment.
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Sequential
Iptacopan (part 1)
DrugTaken for 52 Weeks
Iptacopan (part 2)
DrugTaken for 52 Weeks
Placebo + standard of care
DrugTaken for 52 Weeks
Iptacopan + placebo
DrugTaken for 52 Weeks
Part 1 and 2: Proportion of patients achieving Complete Renal Response (CRR) at week 24 in the absence of renal flares
Part 1: To evaluate the proportion of patients achieving complete renal response with iptacopan treatment "A" plus standard of care, compared to treatment alone Part 2: To evaluate the proportion of patients achieving complete renal response with Iptacopan treatment "B" plus standard of care, compared to treatment "D" alone Part 2: To evaluate the proportion of patients achieving complete renal response with Iptacopan treatment "C" plus standard of care, compared to treatment "D" alone Complete Renal Response is defined as meeting the following criteria: estimated glomerular filtration rate (eGFR) ≥ 90 mL/min/1.73 m2 or no less than 85% of baseline value, and 24h urine protein-to-creatinine ratio (UPCR) ≤ 0.5 g/g.
Parts 1 and 2: Proportion of patients achieving CRR or PRR in the absence of renal flares
Proportion of patients achieving complete renal response or partial renal response
Proportion of patients achieving ≥25% UPCR reduction in the absence of renal flares compared to baseline at week 24
Frequency of renal flares between weeks 24 and 52
Log-transformed ratio to baseline of 24h UPCR at week 24
Dose exposure response for reduction in proteinurea. (each 24h urine protein-to-creatinine ratio value will based on two 24 urine collections sampled within 10 days before the respective study visit)
Change from baseline FACIT-Fatigue Score
Measure fatigue in patients
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