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).
The purpose of this extension study is to evaluate long-term safety and tolerability of ianalumab administered s.c. monthly or quarterly, compared to monthly placebo, in adolescent and adult participants with anti-nuclear antibody (ANA)-positive systemic lupus erythematosus of moderate-to-severe disease activity, who have completed either CVAY736F12301 (SIRIUS-SLE 1) or CVAY736F12302 (SIRIUS-SLE 2) core studies.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
550
Number of treatment-emergent Adverse events/Serious Adverse events
Assessment of long-term safety and tolerability of ianalumab
Time frame: through study completion, up to approximately 91 months
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
Time frame: up to Week 216
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
Time frame: up to Week 216
Average daily dose of oral corticosteroids administered
Evaluating the effect of ianalumab on corticosteroids intake
Time frame: up to Week 216
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
Time frame: up to Week 216
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Pinnacle Research Group Llc
Anniston, Alabama, United States
RECRUITINGProvidence Medical Center
Burbank, California, United States
RECRUITINGAdvanced Medical Research
La Palma, California, United States
RECRUITINGMillennium Clinical Trials
Westlake Village, California, United States
ACTIVE_NOT_RECRUITINGUniversity of Colorado Denver
Aurora, Colorado, United States
RECRUITINGClinical Res Of W Florida
Clearwater, Florida, United States
RECRUITINGGNP Research
Cooper City, Florida, United States
RECRUITINGIRIS Research and Development
Plantation, Florida, United States
RECRUITINGClinical Research of West Florida Inc
Tampa, Florida, United States
RECRUITINGParris and Associates Rheumatology
Lawrenceville, Georgia, United States
RECRUITING...and 133 more locations