OL Extension Study of LNP023 in C3G

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: NCT03955445

Novartis Reference Number: CLNP023B12001B

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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

Condition 
C3 Glomerulopathy
Phase 
Phase 2
Overall status 
Recruiting
Enrollment count 
27 participants
Start date 
Oct 03, 2019
Completion date 
Dec 02, 2024
Gender 
All
Age(s)
18 Years and older (Adult, Older Adult)

Interventions

Drug
LNP023
LNP023 capsules

Eligibility Criteria

Inclusion Criteria:

- Patients must have completed the treatment period of the CLNP023X2202 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 Locations

United States
Novartis Investigative Site
Recruiting
Iowa City, 52242
Iowa
United States
France
Novartis Investigative Site
Recruiting
Montpellier, 34295
-
France
Novartis Investigative Site
Recruiting
Paris, 75015
-
France
Germany
Novartis Investigative Site
Recruiting
Essen, 45147
-
Germany
Italy
Novartis Investigative Site
Recruiting
Ranica, 24020
BG
Italy
Spain
Novartis Investigative Site
Recruiting
Barcelona, 08035
Catalunya
Spain
Novartis Investigative Site
Recruiting
Madrid, 28041
-
Spain
United Kingdom
Novartis Investigative Site
Recruiting
London, W12 0NN
-
United Kingdom
Novartis Investigative Site
Recruiting
Newcastle Upon Tyne, NE7 7DN
-
United Kingdom

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 
1-888-669-6682
Name: 
Novartis Pharmaceuticals
Phone: 
+41613241111
Email: 

Have a question?

Call 1-999-669-6682 or email [email protected]