Last reviewed · How we verify

NCT03955445

Long-term Efficacy, Safety and Tolerability of Iptacopan in C3G or IC-MPGN

Recruiting now Phase 3 Last updated 14 April 2026
What this trial tests

Phase 3 trial testing LNP023 in C3 Glomerulopathy in 225 participants. Currently enrolling.

Timeline
3 October 2019
Primary endpoint
30 May 2036
30 May 2036

Quick facts

Lead sponsorNovartis Pharmaceuticals
PhasePhase 3
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationnon randomized
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment225
Start date3 October 2019
Primary completion30 May 2036
Estimated completion30 May 2036
Sites50 locations across France, Italy, Japan, Netherlands, Greece, United Kingdom, Germany, Israel

Drugs / interventions tested

Conditions studied

Sponsor

Novartis Pharmaceuticals — full company profile →

Who can join

Adults 12 to 100, any sex, with C3 Glomerulopathy or Immune-complex-membranoproliferative Glomerulonephritis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own 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

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Complement Factor D as a Strategic Target for Regulating the Alternative Complement Pathway.
    Barratt J, Weitz I. · · 2021 · cited 88× · PMID 34566967 · DOI 10.3389/fimmu.2021.712572
  2. Efficacy and Safety of Iptacopan in Patients With C3 Glomerulopathy.
    Wong E, Nester C, Cavero T, Karras A, et al · · 2023 · cited 73× · PMID 38106570 · DOI 10.1016/j.ekir.2023.09.017
  3. Alternative Complement Pathway Inhibition With Iptacopan for the Treatment of C3 Glomerulopathy-Study Design of the APPEAR-C3G Trial.
    Bomback AS, Kavanagh D, Vivarelli M, Meier M, et al · · 2022 · cited 51× · PMID 36217526 · DOI 10.1016/j.ekir.2022.07.004
  4. Lipocalin 2-not only a biomarker: a study of current literature and systematic findings of ongoing clinical trials.
    Asaf S, Maqsood F, Jalil J, Sarfraz Z, et al · · 2023 · cited 38× · PMID 36529828 · DOI 10.1007/s12026-022-09352-2
  5. Low-molecular weight inhibitors of the alternative complement pathway.
    Schubart A, Flohr S, Junt T, Eder J. · · 2023 · cited 27× · PMID 36217774 · DOI 10.1111/imr.13143
  6. Protein therapeutics and their lessons: Expect the unexpected when inhibiting the multi-protein cascade of the complement system.
    Schmidt CQ, Smith RJH. · · 2023 · cited 21× · PMID 36398537 · DOI 10.1111/imr.13164
  7. C3 Glomerulopathy: Novel Treatment Paradigms.
    Tarragon Estebanez B, Bomback AS. · · 2024 · cited 17× · PMID 38481517 · DOI 10.1016/j.ekir.2023.12.007
  8. C3G and Ig-MPGN-treatment standard.
    Noris M, Remuzzi G. · · 2024 · cited 17× · PMID 37604793 · DOI 10.1093/ndt/gfad182

Verify or expand the search:

Other trials of LNP023

Trials testing the same drug.

Other recruiting trials for C3 Glomerulopathy

Currently open trials in the same condition.

Other Novartis Pharmaceuticals trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03955445.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing