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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: Completed Phase 3 study, sponsored by Novartis Pharmaceuticals.
NCT04558918 is a Phase 3 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 97 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Sustained increase in hemoglobin levels (responder) is defined as an increase from baseline in hemoglobin levels ≥ 2 g/dL on three out of four measurements taken at the visits occurring in last six weeks (between Day 126 and 168) of the randomized treatment period, without requiring red blood cell (RBC) transfusions between Day 14 and Day 168. Requiring RBC transfusions refers to any patient receiving transfusions or meeting protocol defined criteria (Hemoglobin level ≤ 9 g/dL with signs /and or
Interventions
- DRUG Ravulizumab
- DRUG LNP023
- DRUG Eculizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 97 participants |
| Start Date | 2021-01-25 |
| Est. Completion | 2023-03-06 |
| Phase | Phase 3 |
What the finished NCT04558918 record still lists
NCT04558918 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 97 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 3 interventions - of which Ravulizumab is the first listed.
NCT04558918 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04558918's enrollment target sits among peer trials
97 1718th of 2000 higher than 283 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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