A randomized, double-blind, placebo-controlled extension study to assess the long-term safety and tolerability of ianalumab in patients with systemic lupus erythematosus (SIRIUS-SLE extension)

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-505929-14-00

Acronym

VAY736F12301E1

Enrollment

161

Registered

2024-05-07

Start date

2024-05-21

Completion date

Unknown

Last updated

2026-01-16

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

Conditions

Systemic Lupus Erythematosus

Brief summary

Incidence of treatment-emergent AEs (TEAEs)/SAEs

Detailed description

Proportion of participants who achieved SRI-4 response up to Week 216, Change from baseline in SLICC/ACR Damage Index up to Week 216, Average daily dose of oral corticosteroids administered up to Week 216, Annualized BILAG moderate or severe flare rate up to Week 216, Ianalumab serum concentrations during treatment and follow-up after last dose, Incidence and titer of anti-ianalumab antibodies in serum (ADA assay) over time

Interventions

DRUGVAY736

DRUGTENOFOVIR DISOPROXIL

DRUGTENOFOVIR ALAFENAMIDE

DRUG-

DRUGPlacebo to VAY736 300 mg/2 mL Solution for injection in pre-filled pen

DRUGPlacebo to VAY736 300 mg/2 mL Solution for injection in pre-filled syringe

DRUGENTECAVIR

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Incidence of treatment-emergent AEs (TEAEs)/SAEs	—

Secondary

Measure	Time frame
Proportion of participants who achieved SRI-4 response up to Week 216, Change from baseline in SLICC/ACR Damage Index up to Week 216, Average daily dose of oral corticosteroids administered up to Week 216, Annualized BILAG moderate or severe flare rate up to Week 216, Ianalumab serum concentrations during treatment and follow-up after last dose, Incidence and titer of anti-ianalumab antibodies in serum (ADA assay) over time	—

Measure

Time frame

—

Countries

Bulgaria, Czechia, France, Germany, Hungary, Italy, Poland, Portugal, Romania, Slovakia, Spain

Outcome results

None listed

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