Last Update: Jan 16, 2024
An Open-label, Non-randomized Extension Study to Evaluate the Long-term Efficacy, Safety and Tolerability of LNP023 in Subjects With C3 Glomerulopathy
ClinicalTrials.gov Identifier:
Novartis Reference Number:CLNP023B12001B
All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

Study Description

This is an open-label extension study to evaluate the long-term efficacy, safety and tolerability of LNP023 in subjects with C3 glomerulopathy

The 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 C3 glomerulopathy (C3G) Phase II study CLNP023X2202 or the C3G Phase III study CLNP023B12301. 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) afforded the opportunity to evaluate the effects of iptacopan on potential endpoint(s) for the Phase III trial in C3G at 12 months of treatment. In addition, the enrollment of participants from study CLNP023B12301 permits longer-term evaluation of the persistence of effects observed after 6 months (CLNP023B12301 patients randomised to placebo arm) or 12 months (CLNP023B12301 patients randomised to iptacopan arm) of iptacopan treatment. These longer term efficacy assessments may be compared to historical/concurrent control data available from relevant real world databases in C3G patients and used as supportive information for registration purposes. The extension study is expected to continue until the drug product becomes commercially available and accessible (anticipated to be up to approximately 66 months), or the benefit-risk profile is no longer positive, or the program is discontinued for business or strategic reasons.

Study CLNP023X2202 has enrolled C3G patients with native kidney disease (Cohort A) and C3G patients who have undergone kidney transplant and have recurrence of C3G (Cohort B); CLNP023B12301 will only enroll patients with native kidneys.

"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".

C3 Glomerulopathy
Phase 3
Recruiting
94
Oct 03, 2019
Dec 01, 2028
All
18 Years - (Adult, Older Adult)

Interventions

Drug

LNP023

LNP023 capsules

Eligibility Criteria

Inclusion Criteria:

- Patients must have completed the treatment period of the CLNP023X2202 or CLNP023B12301 trial 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

Study Location

Novartis Investigative Site

Recruiting

Buenos Aires,W3400ABH,Argentina

Novartis Investigative Site

Recruiting

São Paulo,SP,04038-002,Brazil

Novartis Investigative Site

Recruiting

Shanghai,200040,China

Novartis Investigative Site

Recruiting

Beijing,100034,China

Novartis Investigative Site

Recruiting

Montpellier,34295,France

Novartis Investigative Site

Recruiting

Paris,75015,France

Novartis Investigative Site

Recruiting

Erlangen,91054,Germany

Novartis Investigative Site

Recruiting

Essen,45147,Germany

Novartis Investigative Site

Recruiting

Heraklion Crete,711 10,Greece

Novartis Investigative Site

Recruiting

Petach Tikva,4941492,Israel

Novartis Investigative Site

Recruiting

Petach-Tikva,49202,Israel

Novartis Investigative Site

Recruiting

Ranica,BG,24020,Italy

Novartis Investigative Site

Recruiting

Roma,RM,00165,Italy

Novartis Investigative Site

Recruiting

Asahikawa-city,Hokkaido,078-8510,Japan

Novartis Investigative Site

Recruiting

Nagoya,Aichi,466 8560,Japan

Novartis Investigative Site

Recruiting

Sapporo,Hokkaido,060-8543,Japan

Novartis Investigative Site

Recruiting

Leiden,Zuid-Holland,2333 ZA,Netherlands

Novartis Investigative Site

Recruiting

Madrid,28041,Spain

Novartis Investigative Site

Recruiting

Bern,3010,Switzerland

Novartis Investigative Site

Recruiting

Ankara,06500,Turkey

Novartis Investigative Site

Recruiting

Newcastle Upon Tyne,NE7 7DN,United Kingdom

Novartis Investigative Site

Recruiting

London,W12 0NN,United Kingdom

Novartis Investigative Site

Recruiting

Iowa City,Iowa,52242,United States

Novartis Investigative Site

Recruiting

New York,New York,10032,United States

Novartis Investigative Site

Recruiting

Lawrenceville,Georgia,30046,United States

Worldwide Contacts

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Novartis Pharmaceuticals

Novartis Pharmaceuticals