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)

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-515280-60-00

Acronym

CVAY736K12301E1

Enrollment

Registered

2025-03-24

Start date

2025-05-29

Completion date

Unknown

Last updated

2025-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lupus nephritis

Brief summary

Incidence of renal flare, escalation of immunosuppressive medication, or death from Week 144E1 to Week 248, Incidence of TEAEs, SAEs, vital signs and clinical laboratory measurements from the start of treatment in the SIRIUS-LN core study up to EOS of the extension study

Detailed description

Incidence of TEAEs, SAEs, vital signs and clinical laboratory measurements from the start of treatment in the SIRIUS-LN core study up to EOS of the extension study, Incidence and titer of anti-ianalumab antibodies in serum (ADA assay) from Week 144E1 up to Week 248, Ianalumab concentration in serum and calculated PK parameters from Week 144E1 up to Week 248

Interventions

DRUGENTECAVIR

DRUGTENOFOVIR DISOPROXIL

DRUGMYCOPHENOLIC ACID

DRUGVAY736

DRUGMYCOPHENOLATE MOFETIL

DRUG-

DRUGTENOFOVIR ALAFENAMIDE

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Incidence of renal flare, escalation of immunosuppressive medication, or death from Week 144E1 to Week 248, Incidence of TEAEs, SAEs, vital signs and clinical laboratory measurements from the start of treatment in the SIRIUS-LN core study up to EOS of the extension study	—

Secondary

Measure	Time frame
Incidence of TEAEs, SAEs, vital signs and clinical laboratory measurements from the start of treatment in the SIRIUS-LN core study up to EOS of the extension study, Incidence and titer of anti-ianalumab antibodies in serum (ADA assay) from Week 144E1 up to Week 248, Ianalumab concentration in serum and calculated PK parameters from Week 144E1 up to Week 248	—

Countries

Czechia, France, Hungary, Romania, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026