RecruitingPhase 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)

Novartis Pharmaceuticals · NCT06711887

Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

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The purpose of this up to 6-year extension study is the evaluation of the efficacy and safety

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
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.

Being studied: Ianalumab

Conditions: Lupus Nephritis

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion Criteria

Signed informed consent prior to participation in the extension study.
Participants must have participated in the SIRIUS-LN core study and must have completed the entire treatment up to Week 144 on double-blind or open label study treatment.

Exclusion Criteria

Circuit Clinical
Orchard Park, NY 14127
Site contact: Gabriella Demelo · gdemelo@circuitclinical.com