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Clinical trials for LNP023

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44335   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
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    15 result(s) found for: LNP023. Displaying page 1 of 1.
    EudraCT Number: 2017-000889-29 Sponsor Protocol Number: CLNP023X2202 Start Date*: 2018-12-13
    Sponsor Name:Novartis Pharma AG
    Full Title: An open-label, non-randomized study on efficacy, pharmacokinetics, pharmacodynamics, safety and tolerability of LNP023 in two patient populations with C3 glomerulopathy
    Medical condition: C3 glomerulopathy
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) ES (Completed) DE (Completed) FR (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2017-000888-33 Sponsor Protocol Number: CLNP023X2201 Start Date*: 2018-02-05
    Sponsor Name:Novartis Pharma AG
    Full Title: An open label, single arm, multiple dose study to assess efficacy, safety, pharmacokinetics and pharmacodynamics of LNP023 when administered in addition to Standard of Care (SoC) in patients with p...
    Medical condition: Paroxysmal Nocturnal Hemoglobinuria (PNH)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10005329 - Blood and lymphatic system disorders 10018911 Haemolyses and related conditions HLGT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) FR (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2019-001734-34 Sponsor Protocol Number: CLNP023D12201 Start Date*: 2019-09-23
    Sponsor Name:Novartis Pharma AG
    Full Title: A randomized, treatment open-label, dose-blinded, parallel group, three arm, proof-of-concept clinical trial to investigate the efficacy and safety of LNP023 compared with rituximab in the treatmen...
    Medical condition: Idiopathic Membranous nephropathy
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004857 10027170 Membranous nephropathy LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) CZ (Completed) NL (Prematurely Ended) ES (Prematurely Ended) DE (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2017-000891-27 Sponsor Protocol Number: CLNP023X2203 Start Date*: 2017-11-21
    Sponsor Name:Novartis Pharma AG
    Full Title: An adaptive seamless randomized, double-blind, placebo-controlled, dose ranging study to investigate the efficacy and safety of LNP023 in primary IgA nephropathy patients
    Medical condition: Primary IgA Nephropathy
    Disease: Version SOC Term Classification Code Term Level
    20.0 10038359 - Renal and urinary disorders 10029149 Nephropathies HLGT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) SE (Completed) FI (Completed) DE (Completed) BE (Completed) NL (Completed) DK (Completed) CZ (Completed) HU (Completed) FR (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2018-004253-24 Sponsor Protocol Number: CLNP023B12001B Start Date*: 2019-08-28
    Sponsor Name:Novartis Pharma AG
    Full Title: An open-label, non-randomized extension study to evaluate the long-term efficacy, safety and tolerability of LNP023 in subjects with C3 glomerulopathy
    Medical condition: C3 Glomerulopathy
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) IT (Trial now transitioned) FR (Trial now transitioned) ES (Ongoing) DE (Trial now transitioned) GR (Trial now transitioned) NL (Trial now transitioned) CZ (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2020-001049-38 Sponsor Protocol Number: CLNP023A2301 Start Date*: 2020-12-17
    Sponsor Name:Novartis Pharma AG
    Full Title: A multi-center, randomized, double-blind, placebo-controlled, parallel group, phase III study to evaluate the efficacy and safety of LNP023 in primary IgA nephropathy patients
    Medical condition: IgA Nephropathy
    Disease: Version SOC Term Classification Code Term Level
    20.0 10038359 - Renal and urinary disorders 10021263 IgA nephropathy PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Trial now transitioned) FR (Trial now transitioned) SE (Trial now transitioned) DE (Trial now transitioned) DK (Trial now transitioned) NL (Trial now transitioned) NO (Completed) FI (Completed) CZ (Trial now transitioned) BE (Trial now transitioned) IT (Trial now transitioned) SK (Trial now transitioned) SI (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2019-004665-40 Sponsor Protocol Number: CLNP023C12302 Start Date*: 2020-11-03
    Sponsor Name:Novartis Pharma AG
    Full Title: A randomized, multicenter, active-comparator controlled, open-label trial to evaluate efficacy and safety of oral, twice daily LNP023 in adult patients with PNH and residual anemia, despite tre...
    Medical condition: Paroxysmal Nocturnal Hemoglobinuria (PNH)
    Disease: Version SOC Term Classification Code Term Level
    21.1 10038359 - Renal and urinary disorders 10034042 Paroxysmal nocturnal haemoglobinuria PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed) DE (Completed) HU (Completed) CZ (Completed) NL (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2020-004385-19 Sponsor Protocol Number: CLNP023C12001B Start Date*: 2021-07-15
    Sponsor Name:Novartis Pharma AG
    Full Title: An open label, multicenter roll-over extension program (REP) to characterize the long-term safety and tolerability of iptacopan (LNP023) in patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) w...
    Medical condition: Paroxysmal Nocturnal Hemoglobinuria (PNH)
    Disease: Version SOC Term Classification Code Term Level
    21.1 10038359 - Renal and urinary disorders 10034042 Paroxysmal nocturnal haemoglobinuria PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: LT (Trial now transitioned) IT (Trial now transitioned) ES (Ongoing) FR (Trial now transitioned) CZ (Trial now transitioned) NL (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2014-005338-74 Sponsor Protocol Number: CLFG316X2201 Start Date*: 2015-06-17
    Sponsor Name:Novartis Pharma Services AG
    Full Title: An open-label proof of concept study to assess the efficacy, safety and pharmacokinetics of LFG316, an anti-C5 monoclonal antibody in patients with paroxysmal nocturnal hemoglobinuria (PNH)
    Medical condition: Paroxysmal nocturnal hemoglobinuria
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004857 10055629 Paroxysmal nocturnal hemoglobinuria LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed) LT (Completed)
    Trial results: View results
    EudraCT Number: 2020-004589-21 Sponsor Protocol Number: CLNP023B12301 Start Date*: 2021-06-17
    Sponsor Name:Novartis Pharma AG
    Full Title: A multicenter, randomized, double-blind, parallel group, placebo-controlled study to evaluate the efficacy and safety of iptacopan (LNP023) in complement 3 glomerulopathy
    Medical condition: complement 3 glomerulopathy
    Disease: Version SOC Term Classification Code Term Level
    20.0 10038359 - Renal and urinary disorders 10077827 C3 glomerulopathy PT
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: DE (Ongoing) FR (Trial now transitioned) GR (Trial now transitioned) BE (Completed) CZ (Completed) ES (Ongoing) IT (Trial now transitioned) NL (Trial now transitioned) SK (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2021-002046-33 Sponsor Protocol Number: CLNP023K12201 Start Date*: 2022-05-30
    Sponsor Name:Novartis Pharma AG
    Full Title: An adaptive, randomized, double-blind, dose exploration, parallel group, placebo-controlled, multicenter phase 2 trial to evaluate the efficacy, safety and tolerability of LNP023 in combination wit...
    Medical condition: Lupus Nephritis Class III-IV, +/- V
    Disease: Version SOC Term Classification Code Term Level
    21.1 10038359 - Renal and urinary disorders 10025140 Lupus nephritis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Trial now transitioned) FR (Trial now transitioned) ES (Ongoing) PT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2020-003172-41 Sponsor Protocol Number: CLNP023C12301 Start Date*: 2021-06-03
    Sponsor Name:Novartis Pharma AG
    Full Title: A multicenter, single-arm, open-label trial to evaluate efficacy and safety of oral, twice daily iptacopan in adult PNH patients who are naive to complement inhibitor therapy
    Medical condition: Paroxysmal Nocturnal Hemoglobinuria (PNH)
    Disease: Version SOC Term Classification Code Term Level
    21.1 10038359 - Renal and urinary disorders 10034042 Paroxysmal nocturnal haemoglobinuria PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed) CZ (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2020-005186-13 Sponsor Protocol Number: CLNP023F12301 Start Date*: 2021-08-26
    Sponsor Name:Novartis Pharma AG
    Full Title: A multicenter, single-arm, open label trial to evaluate efficacy and safety of oral, twice daily LNP023 in adult aHUS patients who are naive to complement inhibitor therapy
    Medical condition: atypical hemolytic uremic syndrome
    Disease: Version SOC Term Classification Code Term Level
    20.1 10005329 - Blood and lymphatic system disorders 10079841 Atypical hemolytic uremic syndrome LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Trial now transitioned) SI (Trial now transitioned) CZ (Trial now transitioned) SK (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2021-002039-40 Sponsor Protocol Number: CLNP023L12201 Start Date*: 2021-10-29
    Sponsor Name:Novartis Pharma AG
    Full Title: An open-label, multi-center, phase 2 basket study to assess efficacy, safety and pharmacokinetics of iptacopan (LNP023) in participants with autoimmune benign hematological disorders
    Medical condition: Immune thrombocytopenia (ITP) Cold agglutinin disease (CAD)
    Disease: Version SOC Term Classification Code Term Level
    23.0 10005329 - Blood and lymphatic system disorders 10083842 Immune thrombocytopenia PT
    20.0 10005329 - Blood and lymphatic system disorders 10068863 Cold agglutinin disease LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended) IT (Prematurely Ended) ES (Ongoing)
    Trial results: View results
    EudraCT Number: 2020-002200-40 Sponsor Protocol Number: CLNP023A2002B Start Date*: 2021-08-05
    Sponsor Name:Novartis Pharma AG
    Full Title: A multicenter rollover extension program (REP) to evaluate the long-term safety and tolerability of open label iptacopan in adult participants with primary IgA nephropathy who have completed a Nova...
    Medical condition: IgA Nephropathy
    Disease: Version SOC Term Classification Code Term Level
    20.0 10038359 - Renal and urinary disorders 10021263 IgA nephropathy PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Trial now transitioned) BE (Trial now transitioned) DK (Trial now transitioned) CZ (Trial now transitioned) NL (Ongoing) NO (Trial now transitioned) IT (Trial now transitioned) FR (Trial now transitioned)
    Trial results: (No results available)
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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