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

Condition(s) studied

Investigational drug(s) / intervention(s)

Ianalumab: Ianalumab (VAY736) is a human monoclonal antibody (mAb) of the IgG1/κ-class, directed against B cells and binding to BAFF receptor (BAFF-R).

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.

Eligibility

Primary outcome measure(s)

• Cohort 1: Time to renal flare, increase in immunosuppressive medication, or death — Between Week 144E1 and EOS (up to Week 456)
  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
• Cohort 2: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) — From the start of treatment in the SIRIUS-LN core study to EOS (up to week 560) of the extension study
  Number of participants with AEs and SAEs, including changes in vital signs and clinical laboratory measurements qualifying and reported as AEs.

Trial sites (49)

+ 9 more sites — see the full list on the official registry below.