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SIRIUS-SLE Extension Study of Ianalumab in Systemic Lupus Erythematosus
NCT06133972Phase 3
Key facts
- Status
- Recruiting
- Start
- May 2024
- Primary completion
- Apr 2034
- Countries
- 29
- Sponsor
- Novartis
- Modality
- Monoclonal Antibodies
- Drugs
- ianalumab
- Conditions
- systemic lupus erythematosus (SLE)
01
Overview
Phase 3, randomised, double-blind trial of ianalumab in systemic lupus erythematosus (SLE) (3 arms), sponsored by Novartis. Primary endpoint: Number of treatment-emergent Adverse events/Serious Adverse events at 324 weeks. Started May 2024; status: recruiting.
02
Design
3 arms- Study design
- RandomizedDouble-blind
Ianalumab monthly
Ianalumab s.c. monthly
Ianalumab quarterly
Ianalumab s.c. quarterly
Placebo monthly
Placebo s.c. monthly
03
Who it enrols
Participants must be adolescents or adults with ANA-positive systemic lupus erythematosus who completed the treatment period through Week 60 of the SIRIUS-SLE 1 or 2 core studies without discontinuation. Pregnant or nursing women, and those with active infections requiring IV/IM treatment or planning to receive live vaccines are excluded.
04
Endpoints
Primary
Number of treatment-emergent Adverse events/Serious Adverse events
Secondary
Systemic Lupus Erythematosus Responder Index -4 response
Definition of Remission in SLE response
Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index
Average daily dose of corticosteroids administered
Annualized BILAG moderate or severe flare rate
Ianalumab serum concentrations
Incidence and titer of anti-ianalumab antibodies
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