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NCT05630001 · ClinicalTrials.gov registry record · Phase 3
Single Arm, Open Label Trial With Iptacopan Treatment for 24 Weeks, in Patients on Stable Regimen of Anti-C5 Who Switch to Iptacopan.
A Phase 3 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 52
- Enrollment target
NCT05630001: Completed Phase 3 study, sponsored by Novartis Pharmaceuticals.
NCT05630001 is a Phase 3 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 52 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05630001, a Phase 3 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 52 participants
- Enrollment target
Study Summary
The purpose of the study was to find out if iptacopan is effective and safe in adult patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) who switched from their current standard of care treatment (eculizumab or ravulizumab) to study treatment, iptacopan/LNP023.
Primary Outcome
Change in hemoglobin (Hb) levels as mean of visits between Day 126 and Day 168 compared to baseline. Baseline is defined as as the mean of three Hb assessments conducted at the central laboratory: two during screening and the third on Day 1. The estimation of change from baseline in Hb levels was handled by the hypothetical strategy where participants were assumed as if they did not receive RBC transfusions while on treatment (RBC transfusions were expected to be rare). Assuming that particip
Interventions
- DRUG Iptacopan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2023-04-24 |
| Est. Completion | 2024-10-17 |
| Phase | Phase 3 |
What the finished NCT05630001 record still lists
NCT05630001 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 52 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 1 intervention - of which Iptacopan is the first listed.
NCT05630001 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05630001 about?
NCT05630001 is a clinical study titled "Single Arm, Open Label Trial With Iptacopan Treatment for 24 Weeks, in Patients on Stable Regimen of Anti-C5 Who Switch to Iptacopan.". The purpose of the study was to find out if iptacopan is effective and safe in adult patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) who switched from their current standard of care treatment (eculizumab or ravulizumab) to study treatment, iptacopan/LNP023.
What is the current status of trial NCT05630001?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 52 participants. The study started on 2023-04-24. Estimated completion is 2024-10-17.
What interventions are being tested in trial NCT05630001?
The interventions under investigation include: Iptacopan (DRUG).
Who is sponsoring clinical trial NCT05630001?
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 NCT05630001's enrollment target sits among peer trials
52 1841st of 2000 higher than 159 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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