Recruiting
Phase 3

Iptacopan

Sponsor:

Novartis Pharmaceuticals

Code:

NCT03955445

Conditions

C3 Glomerulopathy

Immune-complex-membranoproliferative Glomerulonephritis

Eligibility Criteria

Sex: All

Age: 12 - 70+

Healthy Volunteers: Not accepted

Interventions

LNP023

Study Details

Brief 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

Conditions

C3 Glomerulopathy

Immune-complex-membranoproliferative Glomerulonephritis

Study ID

NCT03955445

Start date

Oct 3, 2019

Status verified date

Aug, 2026

Completion date

May 30, 2036

Anticipated

Primary completion date

May 30, 2036

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

\- Patients must have completed the treatment period of the CLNP023X2202, CLNP023B12301 or CLNP023B12302 study on study drug

Exclusion Criteria:

  • 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

Study Design

Enrollment

225 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Cohort A: participants with native kidneys from CLNP023X2202

C3G participants from study CLNP023X2202 with native kidneys receiving iptacopan capsules 200 mg b.i.d

experimental: Cohort B: participants with transplanted kidneys and recurrent C3G from CLNP023X2202

C3G participants from study CLNP023X2202 who have undergone kidney transplant and have recurrence of C3G receiving iptacopan capsules 200 mg b.i.d

experimental: Cohort C: Participants with native C3G randomized to placebo in CLNP023B12301

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

experimental: Cohort D: particpants with native C3G randomised to iptacopan in CLNP023B12301

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

experimental: Cohort E: participants with IC-MPGN randomized to placebo in CLNP023B12302

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

experimental: Cohort F: participants with IC-MPGN randomized to ipatocan in CLNP023B12302

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

Interventions

LNP023

LNP023 capsules

Primary outcome measure

  • CLNP023X2202 Cohort A-native C3G: Number of participants who achieve the composite renal endpoint [ Time Frame: 9-month visit ]
  • CLNP023X2202 Cohort B - kidney transplant and recurrent C3G: Change from baseline in the C3 Deposit Score [ Time Frame: 6 - to 9- month visit ]
  • 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 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 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 ]

Central Contacts and Locations

Central contacts

Novartis Pharmaceuticals

1-888-669-6682novartis.email@novartis.com

Novartis Pharmaceuticals

+41613241111

Locations

Childrens Hospital Colorado

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Kati Dugan

+1 720 777 6895Kati.Dugan@childrenscolorado.org

Principal Investigator:

Bradley Dixon

Georgia Nephrology Research Inst

Recruiting

Lawrenceville, Georgia, United States, 30046

Contacts

Lisa Franklin

+1 404 645 7850#3024lfranklin@ganephrology.com

Principal Investigator:

James A Tumlin

University of Iowa Health Care

Recruiting

Iowa City, Iowa, United States, 52242-1091

Contacts

Nicole Gerot

+1 319 335 7555nicole-gerot@uiowa.edu

Principal Investigator:

Carla Nester

University of Minnesota

Recruiting

Minneapolis, Minnesota, United States, 55455

Contacts

Brady Wallner

walln080@umn.edu

Principal Investigator:

Nattawat Klomjit

Col Uni Med Center New York Presby

Recruiting

New York, New York, United States, 10032

Contacts

Brianna Ortiz

+1 212 304 5684bo2323@cumc.columbia.edu

Principal Investigator:

Andrew S Bomback

More Information

Sponsor

Novartis Pharmaceuticals

Last update posted

Aug 7, 2026

Last verified

Aug, 2026

Keywords

  • C3G
  • C3 glomerulopathy
  • C3GN
  • C3 glomerulonephritis
  • DDD
  • dense deposit disease
  • iptacopan
  • LNP023
  • IC-MPGN
  • idiopathic immune-complex- membranoproliferative glomerulonephritis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Novartis Pharmaceuticals on 2026-08-07.