A Phase 3 interventional study of Placebo and iptacopan in C3G, sponsored by Novartis Pharmaceuticals. Recruiting at 87 sites in 19 countries. Open to participants aged 12 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-07-13.
Sponsored by Novartis Pharmaceuticals · Phase 3, Interventional, and Treatment
The Primary Completion Date and Study Completion Date have been updated to reflect completion of the adolescent cohort, which has been added to the protocol.
The study is designed as a multicenter, randomized, double-blind, parallel group, placebo-controlled study to evaluate the efficacy and safety of iptacopan (LNP023) in complement 3 glomerulopathy.
The purpose of this study is to evaluate the efficacy and safety of iptacopan compared to placebo and standard of care in patients with native C3G. CLNP023B12301 is a Phase 3 pivotal trial for registration of iptacopan in C3G. The study aims to determine the reduction in UPCR and improvement in eGFR in participants treated with iptacopan compared to placebo, as well as the proportion of participants who achieve a composite renal endpoint consisting of eGFR and UPCR elements. These effects of iptacopan in conjunction with increases in serum C3 levels will provide support for an iptacopan profile that includes stabilization of eGFR, clinically meaningful reductions in proteinuria and inhibition of the complement AP. Kidney biopsies will be performed in adult participants to evaluate histopathological improvements in immunofluorescence and light microscopy that support these functional benefits of iptacopan.
234 studies on the registry are indexed under Proteinuria; 43 are open to participants now.
This study's planned enrollment of 98 is above the median of 60 across 164 interventional studies indexed under Proteinuria.
Browse Proteinuria studies →Novartis Pharmaceuticals is the lead sponsor of 2,673 studies on the registry; 228 are open to participants now.
Of its 576 completed or terminated interventional studies of FDA-regulated products, 431 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
iptacopan 200 mg b.i.d.
Drug: iptacopan
Placebo to iptacopan 200mg b.i.d.
Drug: Placebo
Placebo to iptacopan 200mg b.i.d. (Adults 200mg b.i.d; Adolescents 2x 100mg b.i.d)
iptacopan 200 mg b.i.d. (Adults 200mg b.i.d; Adolescents 2x 100mg b.i.d)
Also known as: LNP023
Adult cohort: Log-transformed ratio to baseline in UPCR (sampled from a 24-hour urine collection)
To demonstrate the superiority of iptacopan compared to placebo in reducing proteinuria at 6 months of treatment.
Time frame: 6 months (double-blind)
Adolescent cohort: Log-transformed ratio to baseline in UPCR (sampled from a 24-hour urine collection)
To evaluate the effect of iptacopan on proteinuria at 6 months.
Time frame: 6 months (double-blind)
Change from baseline in log-transformed UPCR at the 12-month visit (both study treatment arms).
To evaluate the effect of iptacopan on proteinuria at 12 months.
Time frame: 12 months (double-blind and open-label)
Change in log-transformed UPCR from the 6-month visit to the 12-month visit in the placebo arm
To evaluate the effect of iptacopan on proteinuria at 12 months.
Time frame: From month 6 to month 12 (open-label)
Change from baseline in eGFR.
To demonstrate the superiority of iptacopan vs. placebo in improving eGFR.
Time frame: 6 months (double-blind)
Proportion of participants who meet the criteria for achieving a composite renal endpoint
To demonstrate the superiority of iptacopan vs. placebo in the proportion of participants who meet the criteria for achieving a composite renal endpoint. A participant meets the requirements of the composite renal endpoint if he/she satisfies: (1) a stable or improved eGFR compared to the baseline visit (≤15% reduction in eGFR), and (2) a ≥50% reduction in UPCR compared to the baseline visit.
Time frame: 6 months (double-blind)
Adult cohort: Change from baseline in disease total activity score in a renal biopsy.
To demonstrate the effect of iptacopan vs placebo in reducing glomerular inflammation in the kidney.
Time frame: 6 months (double-blind)
Change from baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) score.
To assess the effect of iptacopan compared to placebo in improvement of patient reported fatigue.
Time frame: 6 months (double-blind)
Number of participants with abnormal clinically significant vital signs, ECGs and safety laboratory measurements
To evaluate the safety and tolerability of iptacopan compared to placebo.
Time frame: 6 months (double-blind)
Number of participants with study drug discontinuation due to an AE
To evaluate the safety and tolerability of iptacopan compared to placebo
Time frame: 6 months (double-blind)
Proportion of participants who meet the criteria for achieving a composite renal endpoint
To evaluate the effect at 12 months of iptacopan on a composite renal endpoint. A participant meets the requirements of the composite renal endpoint if he/she satisfies: (1) a stable or improved eGFR compared to the baseline visit (≤15% reduction in eGFR), and (2) a ≥50% reduction in UPCR compared to the baseline visit.
Time frame: 12 months (double-blind and open-label)
Proportion of patients achieving a composite renal endpoint from the 6-month visit to the 12-month visit of the placebo arm
To evaluate the effect at 12 months of iptacopan on a composite renal endpoint. A participant meets the requirements of the composite renal endpoint if he/she satisfies: (1) a stable or improved eGFR compared to the baseline visit (≤15% reduction in eGFR), and (2) a ≥50% reduction in UPCR compared to the 6 months visit.
Time frame: month 6, month 12 (open-label)
Change from baseline in the total activity score in a renal biopsy at 12 months
To evaluate the effect at 12 months of iptacopan in reducing glomerular inflammation in the kidney.
Time frame: Baseline, month 12 (double-blind and open-label)
Change in the total activity score in a renal biopsy from the 6-month visit to the 12-month visit of the placebo arm.
To evaluate the effect at 12 months of iptacopan in reducing glomerular inflammation in the kidney.
Time frame: month 6, month 12 (open-label)
Change from baseline in the FACIT-Fatigue score at 12 months
To evaluate the effect at 12 months of iptacopan in improvement of patient reported fatigue
Time frame: Baseline, month 12 (double-blind and open-label)
Change in the FACIT-Fatigue score from the 6-month visit to the 12-month visit of the placebo arm
To evaluate the effect at 12 months of iptacopan in improvement of patient reported fatigue
Time frame: month 6, month 12 (open-label)
Number of participants with abnormal clinically significant vital signs, ECGs and safety laboratory measurements
To evaluate the safety and tolerability of iptacopan during the 6-month open-label treatment period as well as the entire 12- month treatment period
Time frame: 12 months (double-blind and open-label)
Number of participants with study drug discontinuation due to an AE
To evaluate the safety and tolerability of iptacopan during the 6-month open-label treatment period as well as the entire 12- month treatment period.
Time frame: 12 months (double-blind and open-label)
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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