Long-term Efficacy, Safety and Tolerability of Iptacopan in C3G or IC-MPGN

The primary purpose of this extension study is to collect long-term efficacy, safety and tolerability data in eligible participants receiving open-label iptacopan after completing treatment in the C3G Phase 2 proof of concept study CLNP023X2202.

The primary (at 9 months) and longer-term (\>9 months) efficacy and safety data of iptacopan collected from CLNP023X2202 participants will be used to support health authority submissions.

This umbrella protocol will also allow:

* continued access to iptacopan to patients enrolled in the ongoing Phase 3 programs (C3G and IC-MPGN) * C3G study (CLNP023B12301): adults and adolescents * IC-MPGN study (CLNP023B12302): adults and adolescents * provision of additional efficacy and safety information following longer-term treatment in C3G and IC-MPGN populations to support health authority submissions.

Efficacy and safety assessments at the 9 month visit of this extension study in combination with data from CLNP023X2202 (baseline plus 3 months of treatment) allowed evaluation of the effects of iptacopan on potential endpoint(s) at 12 months of iptacopan treatment in C3G participants. The enrollment of C3G and IC-MPGN participants (adults and adolescents) from Phase 3 studies, CLNP023B12301 and CLNP023B12302, permits longer-term evaluation of the persistence of effects observed after iptacopan treatment. These longer term efficacy and safety assessments may be compared to historical/concurrent control data available from relevant real world databases in C3G or IC-MPGN patients and used as supportive information for registration purposes.

This extension study is expected to continue until the drug product becomes commercially available and accessible (anticipated to be up to approximately 168 months from the first patient first visit date), or the benefit-risk profile is no longer positive, or the program is discontinued for business or strategic reasons.

"Baseline" refers to the Day 1 visit (pre-dose) of CLNP023X2202, CLNP023B12301 or CLNP023B12302, whereas the Day 1 visit for this C3G/IC-MPGN extension study (CLNP023B12001B) is identified as "Extension Day 1".

• CLNP023X2202: Number of participants who achieve the 2-component composite renal endpoint [Срок оценки: 9-month visit]
• CLNP023X2202: Change from baseline in log-transformed urine protein/creatinine ratio (UPCR) [Срок оценки: Participants are expected to continue on study for a minimum of 60 months and a maximum of 84 months]
• CLNP023X2202: Change from baseline in log-transformed urine albumin/creatinine ratio (UACR) [Срок оценки: Participants are expected to continue on study for a minimum of 60 months and a maximum of 84 months]
• CLNP023X2202: Change from baseline in serum creatinine concentration [Срок оценки: Participants are expected to continue on study for a minimum of 60 months and a maximum of 84 months]
• CLNP023X2202: Change from baseline in estimated glomerular filtration rate (eGFR) [Срок оценки: Participants are expected to continue on study for a minimum of 60 months and a maximum of 84 months]
• CLNP023X2202: Status of C3G disease progression [Срок оценки: 6 to 9 month visit]
• CLNP023X2202: Log-transformed ratio to baseline in serum C3 [Срок оценки: Participants are expected to continue on study for a minimum of 60 months and a maximum of 84 months]
• CLNP023X2202: Number of participants who achieve the composite renal endpoint [Срок оценки: Up to 66 months]
• CLNP023X2202: Plasma LNP023 concentration up to 12 months at trough [Срок оценки: 3-months, 6-months, 9-months and 12-months visits]
• CLNP023B12301 and CLNP023B12302: Change from initiation of iptacopan treatment in the core study in log-transformed UPCR over time. [Срок оценки: Participants are expected to continue on study for a minimum of 60 months and a maximum of 84 months]
• CLNP023B12301 and CLNP023B12302: Change from initiation of iptacopan treatment in the core study in eGFR over time. [Срок оценки: Participants are expected to continue on study for a minimum of 60 months and a maximum of 84 months]
• CLNP023B12301 and CLNP023B12302: Number of participants who achieve a 2-component composite renal endpoint [Срок оценки: Participants are expected to continue on study for a minimum of 60 months and a maximum of 84 months]