Long-term Efficacy, Safety and Tolerability of Iptacopan in C3G or IC-MPGN
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age12-100
SponsorNovartis Pharmaceuticals
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
Severe concurrent co-morbidities, e.g. advanced cardiac disease (NYHA class IV), severe pulmonary arterial hypertension (WHO class IV), or any illness or medical condition that in the opinion of the investigator and sponsor is likely to prevent the patient from safely tolerating LNP023 or complying with the requirements of the study
Participants with an active systemic bacterial, viral or fungal infection within 14 days prior to screening, or the presence of fever ≥ 38oC (100.4oF) within 7 days prior to screening.
History or current diagnosis of ECG abnormalities indicating significant risk of safety for subjects
History of HIV or any other immunodeficiency disease
Trial design
Design model
Single group
Treatments tested in this trial
LNP023
DrugLNP023 capsules
Treatment groups
225 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Group A: Cohort A: participants with native kidneys from CLNP023X2202Experimental treatment 1 intervention
Group B: Cohort B: participants with transplanted kidneys and recurrent C3G from CLNP023X2202Experimental treatment 1 intervention
Group C: Cohort C: Participants with native C3G randomized to placebo in CLNP023B12301Experimental treatment 1 intervention
Group D: Cohort D: particpants with native C3G randomised to iptacopan in CLNP023B12301Experimental treatment 1 intervention
Group E: Cohort E: participants with IC-MPGN randomized to placebo in CLNP023B12302Experimental treatment 1 intervention
Group F: Cohort F: participants with IC-MPGN randomized to ipatocan in CLNP023B12302Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 visit2
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 visit3
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 months4
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 monthsSecondary outcomes
1
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 visit2
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 months3
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 months4
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 monthsSponsors and contacts
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Source ClinicalTrials.gov