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NCT03955445
Long-term Efficacy, Safety and Tolerability of Iptacopan in C3G or IC-MPGN
Phase 3 trial testing LNP023 in C3 Glomerulopathy in 225 participants. Currently enrolling.
30 May 2036
Quick facts
| Lead sponsor | Novartis Pharmaceuticals |
|---|---|
| Phase | Phase 3 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 225 |
| Start date | 3 October 2019 |
| Primary completion | 30 May 2036 |
| Estimated completion | 30 May 2036 |
| Sites | 50 locations across France, Italy, Japan, Netherlands, Greece, United Kingdom, Germany, Israel |
Drugs / interventions tested
- LNP023 — full drug profile →
Conditions studied
- C3 Glomerulopathy — all drugs for C3 Glomerulopathy →
- Immune-complex-membranoproliferative Glomerulonephritis — all drugs for Immune-complex-membranoproliferative Glomerulonephritis →
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):
-
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 -
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 -
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 -
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 -
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 -
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 -
C3 Glomerulopathy: Novel Treatment Paradigms.
Tarragon Estebanez B, Bomback AS. · · 2024 · cited 17× · PMID 38481517 · DOI 10.1016/j.ekir.2023.12.007 -
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:
- PubMed search for NCT03955445
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of LNP023
Trials testing the same drug.
- NCT06934967 — Study to Assess the Pharmacokinetics, Safety, and Tolerability of Iptacopan in Pediatric PNH Patients · Phase 3 · recruiting
- NCT06931691 — A Multi-center, Ambispective Cohort Study to Evaluate the Impact of Iptacopan for Adult Patients With PNH in China · recruiting
- NCT04557462 — A Rollover Extension Program (REP) to Evaluate the Long-term Safety and Tolerability of Open Label Iptacopan/LNP023 in P · Phase 3 · recruiting
- NCT04578834 — Study of Efficacy and Safety of LNP023 in Primary IgA Nephropathy Patients · Phase 3 · completed
- NCT04558918 — Study of Efficacy and Safety of Twice Daily Oral LNP023 in Adult PNH Patients With Residual Anemia Despite Anti-C5 Antib · Phase 3 · completed
Other recruiting trials for C3 Glomerulopathy
Currently open trials in the same condition.
- NCT07156149 — Fabhalta Capsules Specified Drug-use Survey · recruiting
- NCT07029542 — Home Reported Outcomes in C3G Study · recruiting
- NCT06065852 — National Registry of Rare Kidney Diseases · recruiting
Other Novartis Pharmaceuticals trials
Trials by the same sponsor.
- NCT07498335 — Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary · Phase 3 · not yet recruiting
- NCT07489573 — Study of Efficacy and Safety of Secukinumab in Chinese Adult Patients With Moderate to Severe Hidradenitis Suppurativa · Phase 4 · not yet recruiting
- NCT07484269 — PULSE Registry: for Patients Receiving Lutetium (177Lu) Vipivotide Tetraxetan · not yet recruiting
- NCT07416162 — A Study of Iptacopan in Korean Patients With Paroxysmal Nocturnal Hemoglobinuria or C3 Glomerulopathy · not yet recruiting
- NCT07387926 — Safety and Efficacy of Asciminib in Pediatrics and Young Adults With Relapse/Refractory (r/r) Philadelphia Positive (Ph+ · Phase 1, PHASE2 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03955445 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Novartis Pharmaceuticals
- Last refreshed: 14 April 2026
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