The purpose of this study is to evaluate long-term safety and tolerability of ianalumab in participants with systemic lupus erythematosus who have previously completed the treatment period in one of the two SIRIUS-SLE core studies (CVAY736F12301 or CVAY736F12302).
Signed informed consent prior to participation in the extension study. Parent or legal guardian's signed informed consent and child's assent, if appropriate, are required before any assessment is performed for participants <18 years of age. Of note, if the participant reaches age of consent (age as per local law) during the study, they will also need to sign the corresponding study Informed Consent Form (ICF) at the next study visit.
Participants must have participated in either one of the two SIRIUS-SLE core studies, CVAY736F12301 or CVAY736F12302, and have completed the treatment period through Week 60 without treatment discontinuation.
In the judgement of the investigator, participants must be expected to clinically benefit from continued study treatment.
Use of prohibited therapies.
Active viral, bacterial or other infections requiring intravenous or intramuscular treatment for clinically significant infection which in the opinion of the investigator will place the participant at risk for participation.
Plans for administration of live vaccines during the study period.
Pregnant or nursing (lactating) women.
Parallel
Placebo
DrugPlacebo s.c. monthly
Ianalumab
DrugIanalumab s.c. monthly Ianalumab s.c. quarterly
Number of treatment-emergent Adverse events/Serious Adverse events
Assessment of long-term safety and tolerability of ianalumab
Proportion of participants who achieved Systemic Lupus Erythematosus Responder Index -4 (SRI-4) response
SRI-4 response is defined as: * Systemic Lupus Erythematosus Disease Activity Index - 2000 (SLEDAI-2K) reduction from baseline of ≥ 4 points * No British Isles Lupus Assessment Group-2004 (BILAG-2004) worsening, defined as ≥ 1 new A or ≥ 2 new B items compared to baseline * No worsening in Physician Global Assessment of Disease Activity (PhGA), defined as an increase of ≥ 0.3 from baseline on a 0 to 3 visual analog scale
Change in Systemic Lupus International Collaborating Clinics/American College of Rheumatology (SLICC/ACR) Damage Index
SLICC/ACR Damage Index is a measure of cumulative damage due to SLE
Average daily dose of oral corticosteroids administered
Evaluating the effect of ianalumab on corticosteroids intake
Annualized BILAG moderate or severe flare rate
Annualized BILAG moderate or severe flare rate where moderate BILAG flare is defined as 2 or more new BILAG-2004 B items, and severe BILAG flare is defined as 1 or more new BILAG-2004 A items, compared to the previous visit
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