OL Extension Study of LNP023 in C3G
C3 Glomerulopathy / Posted 1 year ago
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 and evaluate long-term efficacy, safety and tolerability data in eligible participants receiving open label LNP023 after completing the C3G proof of concept (PoC) study CLNP023X2202. Efficacy assessments at the 9 month visit of the extension study in combination with data from CLNP023X2202 (baseline plus 3 months of treatment) will afford the opportunity to evaluate the effects of LNP023 on potential endpoint(s) for the Phase III trial in C3G at 12 months of treatment. Longer-term efficacy assessments may be used as supportive information for registration purposes.
Inclusion Criteria :
- Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
- Sexes Eligible for Study: All
- Accepts Healthy Volunteers: No
- 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 start date : October 3, 2019
- Study end date : December 2, 2024