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

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: C3 Glomerulopathy, Immune-complex-membranoproliferative Glomerulonephritis

In brief

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

Key facts

Study ID

NCT03955445

Run by

Novartis Pharmaceuticals

People needed

225

Starts

2019-10-03

Expected to finish

2036-05-30

Last updated by the study team

2026-08-07

Who can join

Age: 12 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients must have completed the treatment period of the CLNP023X2202, CLNP023B12301 or CLNP023B12302 study on study drug

You may not qualify if…

• 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

Where it is running

• Novartis Investigative Site — Bari, BA, Italy (enrolling)
• Novartis Investigative Site — Ranica, BG, Italy (enrolling)
• Novartis Investigative Site — Mainz, Germany (enrolling)
• Novartis Investigative Site — Petah Tikva, Israel (enrolling)
• Childrens Hospital Colorado — Aurora, Colorado, United States (enrolling)
• University of Iowa Health Care — Iowa City, Iowa, United States (enrolling)
• University of Minnesota — Minneapolis, Minnesota, United States (enrolling)
• Georgia Nephrology Research Inst — Lawrenceville, Georgia, United States (enrolling)
• Novartis Investigative Site — Porto Alegre, Rio Grande do Sul, Brazil (enrolling)
• Col Uni Med Center New York Presby — New York, New York, United States (enrolling)
• Novartis Investigative Site — CABA, Buenos Aires, Argentina (enrolling)
• Novartis Investigative Site — Salvador, Brazil (enrolling)
• Novartis Investigative Site — Buenos Aires, Argentina (enrolling)
• Novartis Investigative Site — Beijing, China (enrolling)
• Novartis Investigative Site — Shanghai, China (enrolling)
• Novartis Investigative Site — Belo Horizonte, Minas Gerais, Brazil (enrolling)
• Novartis Investigative Site — Montpellier, France (enrolling)
• Novartis Investigative Site — Recife, Pernambuco, Brazil (enrolling)
• Novartis Investigative Site — Paris, France (enrolling)
• Novartis Investigative Site — Toulouse, France (enrolling)
• Novartis Investigative Site — Botucatu, São Paulo, Brazil (enrolling)
• Novartis Investigative Site — Essen, Germany (enrolling)
• Novartis Investigative Site — São Paulo, São Paulo, Brazil (enrolling)
• Novartis Investigative Site — Heidelberg, Germany (enrolling)
• Novartis Investigative Site — Roma, RM, Italy (enrolling)

Full record on ClinicalTrials.gov

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