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

Last Update: Nov 16, 2022

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

Start date

Oct 03, 2019

Completion date

Dec 01, 2028

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