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NCT04558918 · ClinicalTrials.gov registry record · Phase 3

Study of Efficacy and Safety of Twice Daily Oral LNP023 in Adult PNH Patients With Residual Anemia Despite Anti-C5 Antibody Treatment

A Phase 3 study, sponsored by Novartis Pharmaceuticals.

Completed
Registry status
Phase 3
Development phase
97
Enrollment target

NCT04558918 is a Phase 3 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 97 participants.

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The verdict

NCT04558918, a Phase 3 study, has completed, sponsored by Novartis Pharmaceuticals.

COMPLETED
Registry status
Phase 3
Development phase
97 participants
Enrollment target

Study Summary

This study was a multi-center, randomized, open-label, active comparator-controlled, parallel group study. The purpose of this Phase 3 study in PNH patients presenting with residual anemia despite treatment with anti-C5 antibody, was to determine whether iptacopan is efficacious and safe for the treatment of PNH through demonstration of superiority of iptacopan compared to anti-C5 antibody treatment.

Interventions

  • DRUG Ravulizumab
  • DRUG LNP023
  • DRUG Eculizumab

Trial Details

FieldValue
Enrollment Target 97 participants
Start Date 2021-01-25
Est. Completion 2023-03-06
Phase Phase 3

Sponsor

Novartis Pharmaceuticals

1,375 total trials

What the Registry Record Tells You About NCT04558918

The ClinicalTrials.gov registry entry for NCT04558918 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 97 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 3 interventions - of which Ravulizumab is the first listed.

NCT04558918 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT04558918 about?

NCT04558918 is a clinical study titled "Study of Efficacy and Safety of Twice Daily Oral LNP023 in Adult PNH Patients With Residual Anemia Despite Anti-C5 Antibody Treatment". This study was a multi-center, randomized, open-label, active comparator-controlled, parallel group study. The purpose of this Phase 3 study in PNH patients presenting with residual anemia despite treatment with anti-C5 antibody, was to determine whether iptacopan is efficacious and safe for the tr...

What is the current status of trial NCT04558918?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 97 participants. The study started on 2021-01-25. Estimated completion is 2023-03-06.

What interventions are being tested in trial NCT04558918?

The interventions under investigation include: Ravulizumab (DRUG), LNP023 (DRUG), Eculizumab (DRUG).

Who is sponsoring clinical trial NCT04558918?

This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.