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NCT05126277 · ClinicalTrials.gov record · last posted 2026-08-21

Safety, Efficacy and Tolerability of Ianalumab Versus Placebo, Combination With SoC Therapy, in Participants With Active Lupus Nephritis

Name: Safety, Efficacy and Tolerability of Ianalumab Versus Placebo, Combination With SoC Therapy, in Participants With Active Lupus Nephritis — clinical trial record (NCT05126277)
Creator: DataLookout
License: https://creativecommons.org/licenses/by/4.0/

Study acronym: SIRIUS-LN

StatusActive, Not Recruiting

PhasePhase 3

SponsorNovartis Pharmaceuticals

Started2022-07-14

View on ClinicalTrials.gov ↗

from the ClinicalTrials.gov record

This trial will evaluate efficacy, safety, and tolerability of subcutaneous (s.c.) ianalumab given every 4 weeks (q4w) or every 12 weeks (q12w) compared to placebo, in combination with SoC, in adult participants with active LN

Protocol amendment history 4 changes detected by DataLookout

2026-08-22

Trial sites reduced: 156 → 147 locations

2026-08-22

Primary completion pushed: 2027-06-22 → 2027-09-21

2026-05-23

Trial status changed: Recruiting → Active, Not Recruiting

2026-05-23

Trial sites reduced: 188 → 156 locations

Trial Details

NCT Number	NCT05126277
Lead Sponsor	Novartis Pharmaceuticals
Conditions	Lupus Nephritis
Enrollment	452 participants
Start Date	2022-07-14
Primary Completion	2027-09-21 (estimated)
Study Completion	2031-02-04 (estimated)
Updated on ClinicalTrials.gov	2026-08-21