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RecruitingPhase 3

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

Novartis Pharmaceuticals · NCT03955445

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 12–100 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 3
Target enrollment
225
US sites recruiting
5
Study start
October 3, 2019
Record last updated
August 7, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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

Being studied: LNP023

Conditions: C3 Glomerulopathy; Immune-complex-membranoproliferative Glomerulonephritis

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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

Recruiting US locations

  • Childrens Hospital Colorado

    Aurora, CO 80045

    Site contact: Kati Dugan · +1 720 777 6895 · Kati.Dugan@childrenscolorado.org

  • Georgia Nephrology Research Inst

    Lawrenceville, GA 30046

    Site contact: Lisa Franklin · +1 404 645 7850#3024 · lfranklin@ganephrology.com

  • University of Iowa Health Care

    Iowa City, IA 52242-1091

    Site contact: Nicole Gerot · +1 319 335 7555 · nicole-gerot@uiowa.edu

  • University of Minnesota

    Minneapolis, MN 55455

    Site contact: Brady Wallner · walln080@umn.edu

  • Col Uni Med Center New York Presby

    New York, NY 10032

    Site contact: Brianna Ortiz · +1 212 304 5684 · bo2323@cumc.columbia.edu

Study contacts (from the official record)

  • Novartis Pharmaceuticals · 1-888-669-6682 · novartis.email@novartis.com
  • Novartis Pharmaceuticals · +41613241111
Long-term Efficacy, Safety and Tolerability of Iptacopan in C3G or… (NCT03955445) | Bored Studies