Clinical trial

An Open-label, Non-randomized Extension Study to Evaluate the Long-term Efficacy, Safety and Tolerability of LNP023 in Subjects With C3 Glomerulopathy

Name

CLNP023B12001B

Description

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

Trial arms

Trial start

2019-10-03

Estimated PCD

2024-10-31

Trial end

2028-12-01

Status

Recruiting

Phase

Early phase I

Treatment

LNP023

LNP023 capsules

Arms:

Cohort A: participants with native kidneys from CLNP023X2202, Cohort B: participants with transplanted kidneys from CLNP023X2202, Cohort C: Participants with native C3G from CLNP023B12301

Other names:

iptacopan

Size

Primary endpoint

CLNP023X2202 Cohort A-native C3G: Number of participants who achieve the composite renal endpoint

9-month visit

CLNP023X2202 Cohort B - kidney transplant and recurrent C3G: Change from baseline in the C3 Deposit Score

6 - to 9- month visit

Number of AEs of special interest

Up to 66 months for participants from CLNP023X2202 and up to 36 months for participants from CLNP023B12301

Number of participants with study drug discontinuation due to an AE (or any safety issue)

Up to 66 months for participants from CLNP023X2202 and up to 36 months for participants from CLNP023B12301

Number of participants with abnormal clinically significant vital signs,ECGs, and safety laboratory measurements

Up to 66 months for participants from CLNP023X2202 and up to 36 months for participants from CLNP023B12301

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 94, 'type': 'ESTIMATED'}}

Updated at

2024-01-16

1 organization

1 product

1 indication

Organization

Novartis Pharmaceuticals

Product

LNP023

Indication

C3 Glomerulopathy