C3 GlomerulopathyPhase 3NCT03955445
Long-term Efficacy, Safety and Tolerability of Iptacopan in C3G or IC-MPGN
A Phase 3 study testing LNP023 in people with C3 Glomerulopathy and Immune-complex-membranoproliferative Glomerulonephritis, run by Novartis Pharmaceuticals at 53 sites in 17 countries.
Trial 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 Read more about this study
- Who is it for?
- Ages 12 to 100 years
- Conditions the study is for
- C3 Glomerulopathy, Immune-complex-membranoproliferative Glomerulonephritis
- What is being tested?
- LNP023
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 225 participants
- Where
- 53 sitesin 17 countries
- Study dates
- 3 Oct 2019to 30 May 2036
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients must have completed the treatment period of the CLNP023X2202, CLNP023B12301 or CLNP023B12302 study on study drug
Who cannot join
- 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
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
53 sites in 17 countries. Contact the study team or a site near you to ask about taking part.
Novartis Pharmaceuticals contact
53 sites in 17 countries
Japan7 sites, 2 recruiting
- Active, not recruiting
Novartis Investigative Site
Asahikawa, Hokkaido, 0788510
- Recruiting
Novartis Investigative Site
Hachiōji, Tokyo, 193-0998
- Active, not recruiting
Novartis Investigative Site
Nagoya, Aichi-ken, 4668560
- Active, not recruiting
Novartis Investigative Site
Niigata, 9518520
- Recruiting
Novartis Investigative Site
Ohtsu, Shiga, 5202192
- Completed
Novartis Investigative Site
Sapporo, Hokkaido, 0608543
- Active, not recruiting
Novartis Investigative Site
Takatsuki, Osaka, 5691192
Brazil6 sites, 6 recruiting
- Recruiting
Novartis Investigative Site
Belo Horizonte, Minas Gerais, 30150-221
- Recruiting
Novartis Investigative Site
Botucatu, São Paulo, 3880-1001
- Recruiting
Novartis Investigative Site
Porto Alegre, Rio Grande do Sul, 90035-074
- Recruiting
Novartis Investigative Site
Recife, Pernambuco, 50740-900
- Recruiting
Novartis Investigative Site
Salvador, 40323-010
- Recruiting
Novartis Investigative Site
São Paulo, São Paulo, 04038-002
United States5 sites, 5 recruiting
- Recruiting
Childrens Hospital Colorado
Aurora, Colorado, 80045
Kati Dugan, +1 720 777 6895, Kati.Dugan@childrenscolorado.org
Bradley Dixon
- Recruiting
University of Iowa Health Care
Iowa City, Iowa, 52242-1091
Nicole Gerot, +1 319 335 7555, nicole-gerot@uiowa.edu
Carla Nester
- Recruiting
Georgia Nephrology Research Inst
Lawrenceville, Georgia, 30046
Lisa Franklin, +1 404 645 7850#3024, lfranklin@ganephrology.com
James A Tumlin
- Recruiting
University of Minnesota
Minneapolis, Minnesota, 55455
Brady Wallner, walln080@umn.edu
Nattawat Klomjit
- Recruiting
Col Uni Med Center New York Presby
New York, New York, 10032
Brianna Ortiz, +1 212 304 5684, bo2323@cumc.columbia.edu
Andrew S Bomback
Germany5 sites, 3 recruiting
- Active, not recruiting
Novartis Investigative Site
Erlangen, 91054
- Recruiting
Novartis Investigative Site
Essen, 45147
- Active, not recruiting
Novartis Investigative Site
Hamburg, 20246
- Recruiting
Novartis Investigative Site
Heidelberg, 69120
- Recruiting
Novartis Investigative Site
Mainz, 55131
Spain5 sites, 4 recruiting
- Completed
Novartis Investigative Site
Barcelona, 08035
- Recruiting
Novartis Investigative Site
Madrid, 28040
- Recruiting
Novartis Investigative Site
Madrid, 28041
- Recruiting
Novartis Investigative Site
Pamplona, Navarre, 31008
- Recruiting
Novartis Investigative Site
Seville, 41009
France4 sites, 3 recruiting
- Recruiting
Novartis Investigative Site
Montpellier, 34295
- Active, not recruiting
Novartis Investigative Site
Paris, 75015
- Recruiting
Novartis Investigative Site
Paris, 75015
- Recruiting
Novartis Investigative Site
Toulouse, 31054
Italy3 sites, 3 recruiting
- Recruiting
Novartis Investigative Site
Bari, BA, 70124
- Recruiting
Novartis Investigative Site
Ranica, BG, 24020
- Recruiting
Novartis Investigative Site
Roma, RM, 00165
Turkey (Türkiye)3 sites, 2 recruiting
- Recruiting
Novartis Investigative Site
Ankara, Yenimahalle, 06500
- Active, not recruiting
Novartis Investigative Site
Kayseri, Melikgazi, 38039
- Recruiting
Novartis Investigative Site
Köseköy, Kocaeli, 41380
United Kingdom3 sites, 2 recruiting
- Recruiting
Novartis Investigative Site
Cardiff, CF14 4XW
- Recruiting
Novartis Investigative Site
London, W12 0HS
- Active, not recruiting
Novartis Investigative Site
Newcastle upon Tyne, Tyne and Wear, NE7 7DN
Argentina2 sites, 2 recruiting
- Recruiting
Novartis Investigative Site
Buenos Aires, W3400ABH
- Recruiting
Novartis Investigative Site
CABA, Buenos Aires, C1425AGC
China2 sites, 2 recruiting
- Recruiting
Novartis Investigative Site
Beijing, 100034
- Recruiting
Novartis Investigative Site
Shanghai, 200040
Greece2 sites
- Active, not recruiting
Novartis Investigative Site
Heraklion Crete., 715 00
- Active, not recruiting
Novartis Investigative Site
Thessaloniki, 546 42
Israel2 sites, 1 recruiting
- Recruiting
Novartis Investigative Site
Petah Tikva, 4920235
- Active, not recruiting
Novartis Investigative Site
Petah Tikva, 4941492
Canada1 site
- Active, not recruiting
Novartis Investigative Site
Toronto, Ontario, M5G 2C4
Czechia1 site
- Active, not recruiting
Novartis Investigative Site
Prague, 128 08
Netherlands1 site
- Active, not recruiting
Novartis Investigative Site
Leiden, South Holland, 2333 ZA
Switzerland1 site, 1 recruiting
- Recruiting
Novartis Investigative Site
Bern, 3010
About this study
Official title: An Open-label, Non-randomized Extension Study to Evaluate the Long-term Efficacy, Safety and Tolerability of Iptacopan (LNP023) in C3 Glomerulopathy or Idiopathic Immune-complex-membranoproliferative Glomerulonephritis
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
Read the detailed description
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".
- Being tested
- LNP023
- Keywords
- C3G, C3 glomerulopathy, C3GN, C3 glomerulonephritis, DDD, dense deposit disease, iptacopan, LNP023, IC-MPGN, idiopathic immune-complex- membranoproliferative glomerulonephritis
- Medical subject headings
- Glomerulonephritis, Membranoproliferative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LNP023Drug
Also called iptacopan
LNP023 capsules
| Study group | Role | What they receive |
|---|---|---|
| Cohort A: participants with native kidneys from CLNP023X2202 | Experimental | C3G participants from study CLNP023X2202 with native kidneys receiving iptacopan capsules 200 mg b.i.d Receives: Drug: LNP023 |
| Cohort B: participants with transplanted kidneys and recurrent C3G from CLNP023X2202 | Experimental | C3G participants from study CLNP023X2202 who have undergone kidney transplant and have recurrence of C3G receiving iptacopan capsules 200 mg b.i.d Receives: Drug: LNP023 |
| Cohort C: Participants with native C3G randomized to placebo in CLNP023B12301 | Experimental | 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 Receives: Drug: LNP023 |
| Cohort D: particpants with native C3G randomised to iptacopan in CLNP023B12301 | Experimental | 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 Receives: Drug: LNP023 |
| Cohort E: participants with IC-MPGN randomized to placebo in CLNP023B12302 | Experimental | 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 Receives: Drug: LNP023 |
| Cohort F: participants with IC-MPGN randomized to ipatocan in CLNP023B12302 | Experimental | 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 Receives: Drug: LNP023 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Participants are expected to continue on study for a minimum of 60 months and a maximum of 84 months
Secondary outcomes (12)
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.
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: Participants are expected to continue on study for a minimum of 60 months and a maximum of 84 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2019
- Study start3 Oct 2019
- Primary completion30 May 2036 (estimated)
- Study completion30 May 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for C3 GlomerulopathyStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 225 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03955445
- Sponsor's protocol ID
- CLNP023B12001B
- Other IDs
- 2018-004253-24, 2023-509343-27-00, 2023, 2018
- Status last verified
- Aug 2026
- First submitted
- 3 May 2019
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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.
- Expanded access
- Available
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Non-randomized Extension Study to Evaluate the Long-term Efficacy, Safety and Tolerability of Iptacopan (LNP023) in C3 Glomerulopathy or Idiopathic Immune-complex-membranoproliferative Glomerulonephritis
- ClinicalTrials.gov ID
- NCT03955445
- Acronym / sponsor ID
- CLNP023B12001B
- Keywords
- C3G, C3 glomerulopathy, C3GN, C3 glomerulonephritis, DDD, dense deposit disease, iptacopan, LNP023
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 225 participants (estimated)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 3 Oct 2019 (actual)
- Primary completion
- 30 May 2036 (estimated)
- Study completion
- 30 May 2036 (estimated)
- First posted
- 20 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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".
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Cohort A: participants with native kidneys from CLNP023X2202 | Experimental | Drug: LNP023C3G participants from study CLNP023X2202 with native kidneys receiving iptacopan capsules 200 mg b.i.d |
| Cohort B: participants with transplanted kidneys and recurrent C3G from CLNP023X2202 | Experimental | Drug: LNP023C3G participants from study CLNP023X2202 who have undergone kidney transplant and have recurrence of C3G receiving iptacopan capsules 200 mg b.i.d |
| Cohort C: Participants with native C3G randomized to placebo in CLNP023B12301 | Experimental | Drug: LNP023Native C3G Participants (adults and adolescents) from CLNP023B12301 study who were randomized to placebo in the core study receiving iptacopan capsules 200mg b.i.d |
| Cohort D: particpants with native C3G randomised to iptacopan in CLNP023B12301 | Experimental | Drug: LNP023Native C3G participants (adults and adolescents) from study CLNP023B12301 who were randomized to iptacopan in the core study. Receiving iptacopan capsules 200mg b.i.d |
| Cohort E: participants with IC-MPGN randomized to placebo in CLNP023B12302 | Experimental | Drug: LNP023IC-MPGN participants (adults and adolescents) from study CLNP023B12302 who were randomized to placebo in the core study receiving iptacopan capsules 200mg b.i.d |
| Cohort F: participants with IC-MPGN randomized to ipatocan in CLNP023B12302 | Experimental | Drug: LNP023IC-MPGN participants (adults and adolescents) from study CLNP023B12302 who were randomized to iptacopan in the core study receiving iptacopan capsules 200mg b.i.d |
Who may qualify
- Ages
- 12 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients must have completed the treatment period of the CLNP023X2202, CLNP023B12301 or CLNP023B12302 study on study drug
Key exclusion criteria (5 listed)
- 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
- Other protocol-defined inclusion/exclusion criteria may apply
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LNP023Also: iptacopanLNP023 capsules | Drug | Cohort A: participants with native kidneys from CLNP023X2202, Cohort B: participants with transplanted kidneys and recurrent C3G from CLNP023X2202, Cohort C: Participants with native C3G randomized to placebo in CLNP023B12301, Cohort D: particpants with native C3G randomised to iptacopan in CLNP023B12301, Cohort E: participants with IC-MPGN randomized to placebo in CLNP023B12302, Cohort F: participants with IC-MPGN randomized to ipatocan in CLNP023B12302 |
Primary outcome
CLNP023X2202 Cohort A-native C3G: Number of participants who achieve the composite renal endpoint
Time frame: 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
Time frame: 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
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 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
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 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
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 to evaluate the long-term safety and tolerability of iptacopan in participants.
12 secondary outcomes
CLNP023X2202: Number of participants who achieve the 2-component composite renal endpoint
Time frame: 9-month visit
CLNP023X2202: 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)
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
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)
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
Time frame: 6 to 9 month visit
CLNP023X2202: 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
Time frame: Up to 66 months
CLNP023X2202: Plasma LNP023 concentration up to 12 months at trough
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.
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.
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
Time frame: Participants are expected to continue on study for a minimum of 60 months and a maximum of 84 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
- Individual participant dataSharing planned: 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Novartis Pharmaceuticals contact
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
53 sites in 17 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing LNP023 in people with C3 Glomerulopathy and Immune-complex-membranoproliferative Glomerulonephritis, run by Novartis Pharmaceuticals at 53 sites in 17 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 53 sites in Japan, Brazil, United States, Germany, Spain and 12 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Novartis Pharmaceuticals (1-888-669-6682, novartis.email@novartis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CLNP023X2202 Cohort A-native C3G: Number of participants who achieve the composite renal endpoint (time frame: 9-month visit). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2026.