A Phase 3 interventional study of LNP023 in C3 Glomerulopathy and Immune-complex-membranoproliferative Glomerulonephritis, sponsored by Novartis Pharmaceuticals. Recruiting at 53 sites in 17 countries. Open to participants aged 12 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-08-07.
Sponsored by Novartis Pharmaceuticals · Phase 3, Interventional, and Treatment
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
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:
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".
- Patients must have completed the treatment period of the CLNP023X2202, CLNP023B12301 or CLNP023B12302 study on study drug
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
C3G participants from study CLNP023X2202 with native kidneys receiving iptacopan capsules 200 mg b.i.d
Drug: LNP023
C3G participants from study CLNP023X2202 who have undergone kidney transplant and have recurrence of C3G receiving iptacopan capsules 200 mg b.i.d
Drug: LNP023
Native C3G Participants (adults and adolescents) from CLNP023B12301 study who were randomized to placebo in the core study receiving iptacopan capsules 200mg b.i.d
Drug: LNP023
Native C3G participants (adults and adolescents) from study CLNP023B12301 who were randomized to iptacopan in the core study. Receiving iptacopan capsules 200mg b.i.d
Drug: LNP023
IC-MPGN participants (adults and adolescents) from study CLNP023B12302 who were randomized to placebo in the core study receiving iptacopan capsules 200mg b.i.d
Drug: LNP023
IC-MPGN participants (adults and adolescents) from study CLNP023B12302 who were randomized to iptacopan in the core study receiving iptacopan capsules 200mg b.i.d
Drug: LNP023
LNP023 capsules
Also known as: iptacopan
CLNP023X2202 Cohort A-native C3G: Number of participants who achieve the composite renal endpoint
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.
Time frame: 9-month visit
CLNP023X2202 Cohort B - kidney transplant and recurrent C3G: Change from baseline in the C3 Deposit Score
Change from baseline in the C3 Deposit Score (based on immunofluorescence microscopy) compared to baseline in the CLNP023X2202 study.
Time frame: 6 - to 9- month visit
Number of AEs of special interest for participants from CLNP023X2202, CLNP023B12301 and CLNP023B12302
Number of participants with AEs of special interest will be collected to evaluate the long-term safety and tolerability of iptacopan in participants.
Time frame: 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 (or any safety issue) for participants from CLNP023X2202, CLNP023B12301 and CLNP023B12302
Number of participants with study drug discontinuation due to an AE to evaluate the long-term safety and tolerability of iptacopan in participants.
Time frame: 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 for participants from CLNP023X2202, CLNP023B12301 and CLNP023B12302
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.
Time frame: 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 2-component composite renal endpoint
A participant is defined as achieving the composite renal endpoint if they meet 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. Initiation of treatment with eculizumab or any other complement pathway modifying agent automatically designates the participant as a not meeting the composite renal endpoint.
Time frame: 9-month visit
CLNP023X2202: Change from baseline in log-transformed urine protein/creatinine ratio (UPCR)
Long-term effect of LNP023 on renal function in C3G subjects by assessing the change from baseline in log-transformed urine protein/creatinine ratio (UPCR)
Time frame: 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)
Long-term effect of LNP023 on renal function in C3G subjects by assessing the change from baseline in log-transformed urine albumin/creatinine ratio (UACR)
Time frame: 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
Long-term effect of LNP023 on renal function in C3G subjects by assessing the change in serum creatinine compared to CLNP023X2202 baseline
Time frame: 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)
Long-term effect of LNP023 on renal function in C3G subjects by assessing the change in eGFR compared to CLNP023X2202 baseline
Time frame: 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
Describe the status of C3G disease progression based on glomerular histopathology in a renal biopsy at 6 to 9 months from entry to the study compared to those obtained prior to treatment in the CLNP023X2202 study
Time frame: 6 to 9 month visit
CLNP023X2202: Log-transformed ratio to baseline in serum C3
Long-term effect of LNP023 on C3 by evaluating the Log-transformed ratio to baseline in serum C3
Time frame: 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
A participant is defined as achieving the composite renal endpoint if they meet the following criteria at times \>9 months 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., LLN). Initiation of treatment with eculizumab or any other complement pathway modifying agent automatically designates the participant as a not meeting the composite renal endpoint.
Time frame: Up to 66 months
CLNP023X2202: Plasma LNP023 concentration up to 12 months at trough
Measurement of LNP023 plasma concentration to evaluate the pharmacokinetics of iptacopan in participants with prolonged treatment
Time frame: 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.
Change from initiation of iptacopan treatment in the core study in log-transformed UPCR will be assessed to evaluate the long-term effect of iptacopan on proteinuria
Time frame: 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.
Change from initiation of iptacopan treatment in the core study in eGFR over time will be assessed to evaluate the long-term effect of iptacopan on eGFR
Time frame: 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
A participant is defined as meeting the requirements of the composite renal endpoint if they satisfy the eGFR (a stable or improved eGFR, i.e., ≤15% reduction in eGFR compared to the initiation of iptacopan treatment in the core study) and UPCR (≥50% reduction in UPCR compared to the initiation of iptacopan treatment in the core study) criteria assessed at a visit. Initiation of any complement pathway modifying agent or initiation/intensification of corticosteroid or immunosuppressant therapy, or renal replacement therapy automatically designates the participant as not having met the endpoint. The rate will be evaluated over time.
Time frame: Participants are expected to continue on study for a minimum of 60 months and a maximum of 84 months
Plan to share: Yes — Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.
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Glomerulonephritis, Membranoproliferative→
Novartis Pharmaceuticals