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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-100
SponsorNovartis Pharmaceuticals

About this trial

The purpose of this 2-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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

Use of prohibited therapies

Pregnant or nursing (lactating) women.

Trial design

Treatments tested in this trial

  • Ianalumab

Treatment groups

315 Participants
are divided into 2 treatment groups

Locations

25
Brazil
Novartis Investigative Site40150 150, SalvadorEstado de Bahia, Brazil
China
Novartis Investigative Site515000, ShantouGuangdong, China
Novartis Investigative Site545005, LiuzhouGuangxi, China
Novartis Investigative Site430060, WuhanHubei, China

Sponsors and collaborators

Novartis Pharmaceuticals

Lead sponsor