Skip to main content
UK clinical trials - updated daily from ClinicalTrials.gov
TrialConnect
← Back to Search
Looking for participantsPhase3

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

Sponsor: Novartis Pharmaceuticals

NCT ID: NCT03955445

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
LNP023 (drug)
How long the study runs
Study runs about 199 months (dates as stated)
About the drug or intervention
LNP023 — drug: LNP023 capsules
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
12 Years to 100 Years
Who
All
Number of participants
225
Started
2019-10-03
Last checked
2026-08

Plain English Summary

What is this study?

  • • Testing a new treatment for c3 glomerulopathy
  • • Phase3 - 225 participants
  • • 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

Who can take part?

  • • Ages 12 Years to 100 Years
  • • Diagnosed with c3 glomerulopathy

Where?

  • • Newcastle upon Tyne - Novartis Investigative Site
  • • Cardiff - Novartis Investigative Site
  • • London - Novartis Investigative Site

This is a simplified summary. Always discuss with your doctor before making any decisions.

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

More detail

The primary purpose of this extension study is to collect long-term efficacy, safety and tolerability data in eligible participants receiving open-label iptacopan after completing treatment in the C3G Phase 2 proof of concept study CLNP023X2202. The primary (at 9 months) and longer-term (\>9 months) efficacy and safety data of iptacopan collected from CLNP023X2202 participants will be used to support health authority submissions. 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. Efficacy and safety assessments at the 9 month visit of this extension study in combination with data from CLNP023X2202 (baseline plus 3 months of treatment) allowed evaluation of the effects of iptacopan on potential endpoint(s) at 12 months of iptacopan treatment in C3G participants. The enrollment of C3G and IC-MPGN participants (adults and adolescents) from Phase 3 studies, CLNP023B12301 and CLNP023B12302, permits longer-term evaluation of the persistence of effects observed after iptacopan treatment. These longer term efficacy and safety assessments may be compared to historical/concurrent control data available from relevant real world databases in C3G or IC-MPGN patients and used as supportive information for registration purposes. This extension study is expected to continue until the drug product becomes commercially available and accessible (anticipated to be up to approximately 168 months from the first patient first visit date), or the benefit-risk profile is no longer positive, or the program is discontinued for business or strategic reasons. "Baseline" refers to the Day 1 visit (pre-dose) of CLNP023X2202, CLNP023B12301 or CLNP023B12302, whereas the Day 1 visit for this C3G/IC-MPGN extension study (CLNP023B12001B) is identified as "Extension Day 1".

C3 GlomerulopathyImmune-complex-membranoproliferative Glomerulonephritis

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 12 Years - 100 Years
  • Who can join: All genders

What the study is looking for

  • ✓\- Patients must have completed the treatment period of the CLNP023X2202, CLNP023B12301 or CLNP023B12302 study on...

Who cannot take part

  • ✗Participants with an active systemic bacterial, viral or fungal infection within 14 days prior to screening, or the...
  • ✗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
See the full criteria
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

Where Is This Study? (3 UK sites)

Novartis Investigative Site

Newcastle upon Tyne NE7 7DN, United Kingdom

ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Cardiff CF14 4XW, United Kingdom

Recruiting

Novartis Investigative Site

London W12 0HS, United Kingdom

Recruiting

How to Get in Touch

Novartis Pharmaceuticals

Sponsor contact

CONTACT

1-888-669-6682 novartis.email@novartis.com

Novartis Pharmaceuticals

Sponsor contact

CONTACT

+41613241111
Data sourced from ClinicalTrials.gov · Last verified: 2026-08