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

RecruitingPhase 3Ages 18 Years - 100 YearsAllNovartis Pharmaceuticals
NCT06711887 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Signed informed consent prior to participation in the extension study. 2. 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: 1. Use of prohibited therapies 2. Pregnant or nursing (lactating) women.
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What it tests

  • Ianalumab
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Where

51 sites
Circuit Clinical
Orchard Park, United States
Novartis Investigative Site
Vitória, Brazil
Novartis Investigative Site
Salvador, Brazil
Novartis Investigative Site
Belo Horizonte, Brazil
Novartis Investigative Site
Recife, Brazil
Novartis Investigative Site
Santo André, Brazil
Novartis Investigative Site
Guangzhou, China
Novartis Investigative Site
Shantou, China

…and 43 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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