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NCT06711887 · ClinicalTrials.gov record · last posted 2026-08-24

Phase III Extension Study of Efficacy and Safety of Ianalumab With or Without Study Treatment Withdrawal in Participants With Lupus Nephritis (SIRIUS-LN Extension)

Study acronym: SIRIUS-LN ext
StatusRecruiting
PhasePhase 3
Started2025-05-19
View on ClinicalTrials.gov ↗
from the ClinicalTrials.gov record
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.

Protocol amendment history 6 changes detected by DataLookout

2026-08-25
Trial sites expanded: 41 → 47 locations
2026-07-11
Primary endpoint(s) modified
WasCohort 2: Number of participants with Serious Adverse Events (SAE) as assessed by CTCAE v4.0, Cohort 2: Number of participants with Treatment Emergent Adverse Events (TEAE) as assessed by CTAE v4.0, Cohort 2: Number of participants with clinically significant abnormal vital signs, Cohort 2: Number of participants with clinically significant laboratory evaluations., For cohort 1: Incidence of renal flare, escalation of immunosuppressive medication, or death
NowCohort 1: Time to renal flare, increase in immunosuppressive medication, or death, Cohort 2: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
2026-07-11
Enrollment increased: 315 → 348 participants
2026-07-11
Trial sites expanded: 25 → 41 locations
2026-07-11
Primary completion pushed: 2030-07-16 → 2035-08-01
2026-07-11
Completion pushed: 2032-07-16 → 2035-08-01
Trial Details
NCT Number NCT06711887
Lead Sponsor Novartis Pharmaceuticals
Conditions Lupus Nephritis
Enrollment 348 participants
Start Date 2025-05-19
Primary Completion 2035-08-01 (estimated)
Study Completion 2035-08-01 (estimated)
Updated on ClinicalTrials.gov 2026-08-24