Health Trials

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

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

About this trial

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 criteria

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Ianalumab

    Drug

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

Treatment groups

348 Participants
are divided into 2 treatment groups
Group A: Study Treatment Withdrawal (cohort 1)No intervention 0 interventions
Group B: Open-Label Ianalumab (cohort 2)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Cohort 1: Time to renal flare, increase in immunosuppressive medication, or death

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

Time frame
Between Week 144E1 and EOS (up to Week 456)
2

Cohort 2: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)

Number of participants with AEs and SAEs, including changes in vital signs and clinical laboratory measurements qualifying and reported as AEs.

Time frame
From the start of treatment in the SIRIUS-LN core study to EOS (up to week 560) of the extension study

Secondary outcomes

1

Cohort 2: Incidence and titer of anti-ianalumab antibodies in serum (ADA assay)

To assess immunogenicity to ianalumab in Cohort 2

Time frame
from Week 144E1 up to Week 456
2

Cohort 2: Ianalumab concentration in serum using a validated ELISA

To assess pharmacokinetics of ianalumab in Cohort 2

Time frame
from Week 144E1 up to Week 456
3

Cohort 1: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)

Number of participants with AEs and SAEs, including changes in vital signs and clinical laboratory measurements qualifying and reported as AEs.

Time frame
From the start of treatment in the SIRIUS-LN core study to EOS (up to week 560) of the extension study

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Novartis Pharmaceuticals

Lead sponsor

Source ClinicalTrials.gov
Apply now