West Santa Monica, California

Combined Dose-Finding and CV Outcomes Study With CSL300 (Clazakizumab) in Adult Subjects With ESKD Undergoing Dialysis

A Rollover Extension Program (REP) to Evaluate the Long-term Safety and Tolerability of Open Label Iptacopan/LNP023 in Participants With Primary IgA Nephropathy

This is an open-label, non-randomized, multicenter roll-over extension program (REP) to: - CLNP023X2203, a Phase II trial investigating the dose ranging effects of LNP023 on efficacy, pharmacokinetics (PK), pharmacodynamics (PD), safety and tolerability in primary IgAN patients, and - CLNP023A2301, a Phase III trial, investigating the efficacy, pharmacokinetics (PK), pharmacodynamics (PD), safety and tolerability of LNP023 in patients with primary IgAN. Subjects completing the CLNP023X2203 and CLNP023A2301 trials on study drug, who want to continue treatment and who meet the inclusion/exclusion requirements of the roll over extension program, will have the opportunity to receive iptacopan until: - 3 years from LPFV of this study CLNP023A2002B, or - the participant no longer derives benefit from iptacopan according to the Investigator, or - the benefit-risk profile of the product in IgAN is no longer positive, or - initiation of maintenance hemodialysis, kidney transplantation or eGFR < 15 mL/min/1.73m2 , or - the product becomes commercially available in a specific country following product launch and subsequent reimbursement for IgAN, where applicable, or - if a marketing application or reimbursement of an investigational product is rejected/not pursued in a region/country for the indication under study or which ever is sooner