Home › NCT03955445

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

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

Who can join

Ages 12 to 100 · All sexes

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

About the study

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

What is being tested

• LNP023 (drug)

Sponsor: Novartis Pharmaceuticals · Participants: 225 · Started: Oct 3, 2019

Contact the study team

• Novartis Pharmaceuticals · Phone: 1-888-669-6682
• Novartis Pharmaceuticals · Phone: +41613241111

Official record on ClinicalTrials.gov — NCT03955445

Locations in the U.S.

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.