RecruitingPhase 3

Long-term Efficacy, Safety and Tolerability of Iptacopan in C3G or IC-MPGN

United States225 participantsStarted 2019-10-03

Plain-language summary

This is an open-label extension study to evaluate the long-term efficacy, safety and tolerability of iptacopan in subjects with C3 glomerulopathy or idiopathic immune-complex-membranoproliferative glomerulonephritis

Who can participate

Age range12 Years – 100 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: \- Patients must have completed the treatment period of the CLNP023X2202, CLNP023B12301 or CLNP023B12302 study 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 Other protocol-defined inclusion/exclusion criteria may apply

What they're measuring

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

Timeframe: 9-month visit

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

Timeframe: 6 - to 9- month visit

Number of AEs of special interest for participants from CLNP023X2202, CLNP023B12301 and CLNP023B12302

Timeframe: Participants are expected to continue on study for a minimum of 60 months and a maximum of 84 months

Number of participants with study drug discontinuation due to an AE (or any safety issue) for participants from CLNP023X2202, CLNP023B12301 and CLNP023B12302

Timeframe: Participants are expected to continue on study for a minimum of 60 months and a maximum of 84 months

Number of participants with abnormal clinically significant vital signs,ECGs, and safety laboratory measurements for participants from CLNP023X2202, CLNP023B12301 and CLNP023B12302

Timeframe: Participants are expected to continue on study for a minimum of 60 months and a maximum of 84 months

Trial details

NCT IDNCT03955445

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2036-05-30

Contact for this trial

Novartis Pharmaceuticals

1-888-669-6682 novartis.email@novartis.com

View on ClinicalTrials.gov More C3 Glomerulopathy trials

Who can participate

Age range12 Years – 100 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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

Timeframe: 9-month visit

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

Timeframe: 6 - to 9- month visit

Number of AEs of special interest for participants from CLNP023X2202, CLNP023B12301 and CLNP023B12302

Timeframe: Participants are expected to continue on study for a minimum of 60 months and a maximum of 84 months

Number of participants with study drug discontinuation due to an AE (or any safety issue) for participants from CLNP023X2202, CLNP023B12301 and CLNP023B12302

Timeframe: Participants are expected to continue on study for a minimum of 60 months and a maximum of 84 months

Number of participants with abnormal clinically significant vital signs,ECGs, and safety laboratory measurements for participants from CLNP023X2202, CLNP023B12301 and CLNP023B12302

Timeframe: Participants are expected to continue on study for a minimum of 60 months and a maximum of 84 months