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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age12-100
SponsorNovartis Pharmaceuticals

About this trial

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

Eligibility criteria

Qualifiers

None

Disqualifiers

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

Trial design

Treatments tested in this trial

  • LNP023

Treatment groups

225 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Sponsors and collaborators