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

Condition(s) studied

Investigational drug(s) / intervention(s)

LNP023: LNP023 capsules

Study summary

This is an open-label extension study to evaluate the long-term efficacy, safety and tolerability of iptacopan in subjects with C3 glomerulopathy or idiopathic immune-complex-membranoproliferative glomerulonephritis

Eligibility

Primary outcome measure(s)

• CLNP023X2202 Cohort A-native C3G: Number of participants who achieve the composite renal endpoint — 9-month visit
  A participant meets the requirements of the composite renal endpoint if they satisfy the following criteria at the 9-month visit in CLNP023B12001B: (1) a stable or improved eGFR compared to the baseline visit in CLNP023X2202 (≤10% reduction in eGFR), and (2) either ≥50% reduction compared to the baseline visit in CLNP023X2202 or a reduction to \<300 mg/g in UPCR and (3) either a ≥50% increase in C3 compared to baseline or an increase to ≥90 mg/dL (i.e., ≥ the lower limit of normal (LLN)). Initiation of treatment with eculizumab or any other complement pathway modifying agent automatically designates the participant as not meeting the endpoint.
• CLNP023X2202 Cohort B - kidney transplant and recurrent C3G: Change from baseline in the C3 Deposit Score — 6 - to 9- month visit
  Change from baseline in the C3 Deposit Score (based on immunofluorescence microscopy) compared to baseline in the CLNP023X2202 study.
• Number of AEs of special interest for participants from CLNP023X2202, CLNP023B12301 and CLNP023B12302 — Participants are expected to continue on study for a minimum of 60 months and a maximum of 84 months
  Number of participants with AEs of special interest will be collected to evaluate the long-term safety and tolerability of iptacopan in participants.
• Number of participants with study drug discontinuation due to an AE (or any safety issue) for participants from CLNP023X2202, CLNP023B12301 and CLNP023B12302 — Participants are expected to continue on study for a minimum of 60 months and a maximum of 84 months
  Number of participants with study drug discontinuation due to an AE to evaluate the long-term safety and tolerability of iptacopan in participants.
• Number of participants with abnormal clinically significant vital signs,ECGs, and safety laboratory measurements for participants from CLNP023X2202, CLNP023B12301 and CLNP023B12302 — Participants are expected to continue on study for a minimum of 60 months and a maximum of 84 months
  Number of participants with abnormal clinically significant vital signs, ECGs, and safety laboratory measurements to evaluate the long-term safety and tolerability of iptacopan in participants.

Trial sites (53)

+ 13 more sites — see the full list on the official registry below.

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