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NCT06711887RecruitingPhase 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)

An Open-label Extension Study to Assess the Efficacy and Safety of Ianalumab With or Without Study Treatment Withdrawal in Adult Participants With Lupus Nephritis Who Have Completed Study Treatment in the CVAY736K12301 Core Study (SIRIUS-LN Extension)

Source: ClinicalTrials.gov · Last updated 13 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
348 (estimated)
First submitted
11 Nov 2024
Start date
19 May 2025
Primary completion date
1 Aug 2035
Lead sponsor
Novartis Pharmaceuticals
Diseases
Lupus (SLE)
NCT number
NCT06711887
EU CT number
2024-515280-60-00

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 348
  • From 19 May 2025 to the primary completion date, 1 Aug 2035
  • 52 sites in 19 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Use of prohibited therapies

Other

  • Pregnant or nursing (lactating) women.

Who the study is looking for

  • 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.

Age in the registry: 18 years to 100 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (52)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
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Belo HorizonteBrazilRecruiting
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RecifeBrazilRecruiting
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SalvadorBrazilRecruiting
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Santo AndréBrazilRecruiting
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VitóriaBrazilRecruiting
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BeijingChinaRecruiting
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BinzhouChinaRecruiting
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ChangchunChinaRecruiting
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ChongqingChinaRecruiting
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GuangzhouChinaRecruiting
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LiuzhouChinaRecruiting
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NingboChinaRecruiting
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ShanghaiChinaRecruiting
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ShantouChinaActive, not recruiting
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ShenyangChinaRecruiting
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ShenzhenChinaRecruiting
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WuhanChinaRecruiting
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BarranquillaColombiaRecruiting
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MedellínColombiaRecruiting
University Hospital Olomouc
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OlomoucCzechiaRecruiting
Revmatologicky Ustav
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Prague 2CzechiaRecruiting
Hospital Universitari Vall d'Hebron
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BarcelonaSpainRecruiting
Clínica Universidad de navarra
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PamplonaSpainRecruiting
Complexo Hospitalario Universitario De Vigo
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VigoSpainRecruiting
CHU Besancon
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Besancon CedexFranceRecruiting
Centre hospitalier Universitaire de Bordeaux
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BordeauxFranceRecruiting
Centre Hospitalier Universitaire Grenoble Alpes
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Grenoble Cedex 9FranceRecruiting
Centre Hospitalier Regional De Marseille
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MarseilleFranceRecruiting
Centre Hospitalier Universitaire de Poitiers
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PoitiersFranceRecruiting
Centre Hospitalier Universitaire De Toulouse
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Toulouse Cedex 9FranceRecruiting
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Guatemala CityGuatemalaRecruiting
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QuetzaltenangoGuatemalaRecruiting
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TuenmenHong Kong SAR ChinaRecruiting
Del-Pesti Centrumkorhaz Orszagos Hematologiai Es Infektologiai Intezet
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Budapest IXHungaryRecruiting
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SeoulSouth KoreaRecruiting
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SuwonSouth KoreaRecruiting
Lietuvos sveikatos mokslu universiteto ligonine Kauno klinikos
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KaunasLithuaniaNot yet recruiting
Vilniaus universiteto ligonine Santaros klinikos VšĮ
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VilniusLithuaniaNot yet recruiting
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LeónMexicoRecruiting
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Oaxaca CityMexicoRecruiting
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QuerétaroMexicoRecruiting
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Kuala LumpurMalaysiaRecruiting
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SibuMalaysiaRecruiting
Institutul Clinic Fundeni
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BucharestRomaniaRecruiting
Spitalul Clinic Judetean De Urgenta Bihor
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OradeaRomaniaRecruiting
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SingaporeSingaporeRecruiting
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BangkokThailandRecruiting
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Chiang MaiThailandRecruiting
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SongkhlaThailandRecruiting
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TaichungTaiwanRecruiting
Circuit Clinical
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Orchard ParkUnited StatesRecruiting
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Ho Chi Minh CityVietnamRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.