For Healthcare Professionals

Long-term Efficacy, Safety and Tolerability of LNP023 in C3G

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About the study

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

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

Inclusion Criteria:


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


EXCLUSION CRITERIA

Exclusion Criteria:


  1. 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
  2. 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.
  3. History or current diagnosis of ECG abnormalities indicating significant risk of safety for subjects
  4. History of HIV or any other immunodeficiency disease

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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.

Study’s details


Contition

C3 Glomerulopathy

Age (in years)

18+

Phase

Phase 3

Participants needed

94

Est. Completion Date

Dec 1, 2028

Treatment type

Interventional


Sponsor

Novartis

ClinicalTrials.gov identifier

NCT03955445

Study number

CLNP023B12001B

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