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

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 "Baseline" refers to the Day 1 visit (pre-dose) of CLNP023X2202 or CLNP023B12301, whereas the Day 1 visit for this C3G extension study (CLNP023B12001B) is identified as "Extension Day 1". This umbrella protocol will also allow: continued access to iptacopan to patients enrolled in the ongoing Phase 3 programs (C3G and IC-MPGN) C3G study (CLNP023B12301): adults and adolescents IC-MPGN study (CLNP023B12302): adults and adolescents provision of additional efficacy and safety information following longer-term treatment in C3G and IC-MPGN populations to support health authority submissions.

CT.gov Identifier
NCT03955445
EudraCT Identifier
2018-004253-24
CTIS:
2023-509343-27-00
Sponsor
Novartis
Collaborator
N/A
Study Contact Information
+41 61 324 0000
Recruiting
Contact Us

Study Details

Diseases
Glomerulonephritis and atypical hemolytic uremic syndrome (aHUS)
Atypical Hemolytic Uremic Syndrome; C3 Glomerulopathy; Complement Factor H Deficiency
Study Drug
Iptacopan
Genes
CFI
CFH
Study Dates
Oct 2019 - May 2026
Sex
Female & Male
Age
18 - 100 Years
Inclusion and Exclusion Criteria
Inclusion Criteria:
  • - Patients must have completed the treatment period of the CLNP023X2202, CLNP023B12301 or CLNP023B12302 study on study drug
  • 1 Written informed consent must be obtained prior to any assessment.
  • 2 Male and female patients aged ≥ 18 years at screening.
  • 3 Patients must have completed the treatment period of the study drug CLNP023X2202 or CLNP023B12301 trial.
  • 4 Patients or their legal representatives must be able to communicate well with investigators, understand and comply with research requirements [applies to all countries except Germany]
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

Protocol Summary

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

"Baseline" refers to the Day 1 visit (pre-dose) of CLNP023X2202 or CLNP023B12301, whereas the Day 1 visit for this C3G extension study (CLNP023B12001B) is identified as "Extension Day 1".

This umbrella protocol will also allow:

continued access to iptacopan to patients enrolled in the ongoing Phase 3 programs (C3G and IC-MPGN)

C3G study (CLNP023B12301): adults and adolescents

IC-MPGN study (CLNP023B12302): adults and adolescents

provision of additional efficacy and safety information following longer-term treatment in C3G and IC-MPGN populations to support health authority submissions.

Study Locations

To view all trial locations, click here

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