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NCT06711887 · ClinicalTrials.gov registry record · Phase 3
Phase III Extension Study of Efficacy and Safety of Ianalumab With or Without Study Treatment Withdrawal in Participants With Lupus Nephritis (SIRIUS-LN Extension)
A Phase 3 study, sponsored by Novartis Pharmaceuticals.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 348
- Enrollment target
NCT06711887: Recruiting Phase 3 study, sponsored by Novartis Pharmaceuticals.
NCT06711887 is a Phase 3 study that is actively recruiting participants, run by Novartis Pharmaceuticals. The registered enrollment target is 348 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (55% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06711887, a Phase 3 study, is actively recruiting participants, sponsored by Novartis Pharmaceuticals.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 348 participants
- Enrollment target
Study Summary
The purpose of this up to 6-year extension study is the evaluation of the efficacy and safety 1. after study treatment withdrawal in patients with lupus nephritis (LN) who achieved response (complete renal response \[CRR\] or partial renal response \[PRR\]) on double-blind treatment at the end of the SIRIUS-LN core study, and 2. of open-label ianalumab 300 mg treatment in patients who, at the end of the SIRIUS-LN core study, were either already receiving ianalumab open-label treatment or did not meet CRR/PRR criteria on double-blind treatment at the end of the SIRIUS-LN core study.
Primary Outcome
Cohort 1: To estimate the time to renal flare, increase in immunosuppressive medication, or death following study treatment withdrawal in participants who completed the SIRIUS-LN core study on double-blind treatment and achieved CRR or PRR at Week 140 of the core study
Interventions
- DRUG Ianalumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 348 participants |
| Start Date | 2025-05-19 |
| Est. Completion | 2035-08-01 |
| Phase | Phase 3 |
What NCT06711887 shows while recruiting
NCT06711887 is an interventional study that assigns participants to a tested intervention. The registered 348 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (55% lower).
The record links to 0 conditions, and to 1 intervention - of which Ianalumab is the first listed.
NCT06711887 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06711887 about?
NCT06711887 is a clinical study titled "Phase III Extension Study of Efficacy and Safety of Ianalumab With or Without Study Treatment Withdrawal in Participants With Lupus Nephritis (SIRIUS-LN Extension)". The purpose of this up to 6-year extension study is the evaluation of the efficacy and safety 1. after study treatment withdrawal in patients with lupus nephritis (LN) who achieved response (complete renal response \[CRR\] or partial renal response \[PRR\]) on double-blind treatment at the end of t...
What is the current status of trial NCT06711887?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 348 participants. The study started on 2025-05-19. Estimated completion is 2035-08-01.
What interventions are being tested in trial NCT06711887?
The interventions under investigation include: Ianalumab (DRUG).
Who is sponsoring clinical trial NCT06711887?
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 NCT06711887's enrollment target sits among peer trials
348 1045th of 2000 higher than 953 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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