Last Update: Aug 07, 2026 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 Identifier: [NCT03955445](https://clinicaltrials.gov/ct2/show/NCT03955445) Novartis Reference Number:CLNP023B12001B [See if you Pre-qualify](#trial-eligibility "See if you Pre-qualify") All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. ## Study Description 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: \* 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". Condition C3 Glomerulopathy, Immune-complex-membranoproliferative Glomerulonephritis Phase Phase3 Overall Status Recruiting Number of Participants225 Start Date Oct 03, 2019 Completion Date May 30, 2036 Gender All Age(s) 12 Years - 100 Years (Child, Adult, Older Adult) ## Interventions Drug ### LNP023 LNP023 capsules ## Eligibility Criteria 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 Argentina #### Novartis Investigative Site Recruiting Buenos Aires,W3400abh,Argentina #### Novartis Investigative Site Recruiting CABA,Buenos Aires,C1425agc,Argentina Brazil #### Novartis Investigative Site Recruiting Salvador,40323-010,Brazil #### Novartis Investigative Site Recruiting Belo Horizonte,Minas Gerais,30150-221,Brazil #### Novartis Investigative Site Recruiting Porto Alegre,Rio Grande do Sul,90035-074,Brazil #### Novartis Investigative Site Recruiting Botucatu,São Paulo,3880-1001,Brazil #### Novartis Investigative Site Recruiting São Paulo,São Paulo,04038-002,Brazil #### Novartis Investigative Site Recruiting Recife,Pernambuco,50740-900,Brazil China #### Novartis Investigative Site Recruiting Shanghai,200040,China #### Novartis Investigative Site Recruiting Beijing,100034,China France #### Novartis Investigative Site Recruiting Paris,75015,France #### Novartis Investigative Site Recruiting Montpellier,34295,France #### Novartis Investigative Site Recruiting Toulouse,31054,France Germany #### Novartis Investigative Site Recruiting Essen,45147,Germany #### Novartis Investigative Site Recruiting Mainz,55131,Germany #### Novartis Investigative Site Recruiting Heidelberg,69120,Germany Israel #### Novartis Investigative Site Recruiting Petah Tikva,4920235,Israel Italy #### Novartis Investigative Site Recruiting Roma,RM,00165,Italy #### Novartis Investigative Site Recruiting Bari,BA,70124,Italy #### Novartis Investigative Site Recruiting Ranica,BG,24020,Italy Japan #### Novartis Investigative Site Recruiting Ohtsu,Shiga,5202192,Japan #### Novartis Investigative Site Recruiting Hachiōji,Tokyo,193-0998,Japan Spain #### Novartis Investigative Site Recruiting Seville,41009,Spain #### Novartis Investigative Site Recruiting Madrid,28040,Spain #### Novartis Investigative Site Recruiting Pamplona,Navarre,31008,Spain #### Novartis Investigative Site Recruiting Madrid,28041,Spain Switzerland #### Novartis Investigative Site Recruiting Bern,3010,Switzerland Turkey (Türkiye) #### Novartis Investigative Site Recruiting Ankara,Yenimahalle,06500,Turkey (Türkiye) #### Novartis Investigative Site Recruiting Köseköy,Kocaeli,41380,Turkey (Türkiye) United Kingdom #### Novartis Investigative Site Recruiting London,W12 0hs,United Kingdom #### Novartis Investigative Site Recruiting Cardiff,Cf14 4xw,United Kingdom United States #### Georgia Nephrology Research Inst Recruiting Lawrenceville,Georgia,30046,United States ###### James A Tumlin ###### Lisa Franklin Phone: [+1 404 645 7850#3024]() Email: #### Col Uni Med Center New York Presby Recruiting New York,New York,10032,United States ###### Brianna Ortiz Phone: [+1 212 304 5684]() Email: ###### Andrew S Bomback #### University of Iowa Health Care Recruiting Iowa City,Iowa,52242-1091,United States ###### Nicole Gerot Phone: [+1 319 335 7555]() Email: ###### Carla Nester #### University of Minnesota Recruiting Minneapolis,Minnesota,55455,United States ###### Nattawat Klomjit ###### Brady Wallner Email: #### Childrens Hospital Colorado Recruiting Aurora,Colorado,80045,United States ###### Bradley Dixon ###### Kati Dugan Phone: [+1 720 777 6895]() Email: ## Worldwide Contacts If the location of your choosing does not feature any contact detail, please reach out using the information below. #### Novartis Pharmaceuticals Phone: [ +41613241111](tel:+41613241111) Email: [](mailto:) #### Novartis Pharmaceuticals Phone: [ 1-888-669-6682](tel:1-888-669-6682) Email: