The Primary Completion Date and Study Completion Date have been updated to reflect completion of the adolescent cohort, which has been added to the protocol. The study is designed as a multicenter, randomized, double-blind, parallel group, placebo-controlled study to evaluate the efficacy and safety of iptacopan (LNP023) in complement 3 glomerulopathy.
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Adult cohort: Log-transformed ratio to baseline in UPCR (sampled from a 24-hour urine collection)
Timeframe: 6 months (double-blind)
Adolescent cohort: Log-transformed ratio to baseline in UPCR (sampled from a 24-hour urine collection)
Timeframe: 6 months (double-blind)
Change from baseline in log-transformed UPCR at the 12-month visit (both study treatment arms).
Timeframe: 12 months (double-blind and open-label)
Change in log-transformed UPCR from the 6-month visit to the 12-month visit in the placebo arm
Timeframe: From month 6 to month 12 (open-label)