Resumen

The trial will evaluate efficacy, safety and tolerability of ianalumab compared to placebo, given as monthly subcutaneous (s.c.) injection on top of standard-of-care (SoC) treatment in participants with active systemic lupus erythematosus (SLE).

Descripción detallada

A randomized, double-blind, placebo-controlled multicenter phase 3 study to evaluate efficacy, safety and tolerability of ianalumab on top of standard-of-care therapy in patients with systemic lupus erythematosus (SIRIUS-SLE 2)

Elegibilidad

Edad mínima: 12 YearsEdad máxima: 100 YearsSexo: ALL

Criterios de inclusión

Male and female participants aged 12 years or older at the time of screening, or limited to 18 years or older in European Economic Area countries and other countries where inclusion of participants below 18 years is not allowed.
Diagnosis of systemic lupus erythematosus meeting the 2019 European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) SLE classification criteria at least 6 months prior to screening.
Elevated serum titers at screening of anti-nuclear antibodies ≥ 1:80 as determined by a central laboratory with a SLE-typical fluorescence pattern.
Currently receiving CS and/or anti-malarial treatment and/or another disease-modifying antirheumatic drug (DMARD) as specified in the protocol.
SLEDAI-2K criteria at screening: SLEDAI-2K score ≥ 6 points, excluding points attributed to "fever", "lupus headache", "alopecia", and "organic brain syndrome"
BILAG-2004 disease activity level at screening of at least 1 of the following:
BILAG-2004 level 'A' disease in ≥ 1 organ system, Or
BILAG-2004 level 'B' disease in ≥ 2 organ systems
Weigh at least 35 kg at screening
Active viral, bacterial or other infections requiring intravenous or intramuscular treatment for clinically significant infection
Chronic infection with hepatitis B virus (HBV) or hepatitis C virus (HCV)
Evidence of active tuberculosis infection
History of primary or secondary immunodeficiency, including a positive human immunodeficiency virus (HIV) test result at screening
Any one of the following abnormal laboratory values prior to randomization:
Platelets \< 25000/ mm\^3 (\< 25 x 10\^3/ μL)
Hemoglobin (Hgb) \< 8.0 g/dL (\< 5 mmol/L), or \< 7.0 g/dL (\< 4.3 mmol/L) if related to participant's SLE such as in active hemolytic anaemia
Absolute neutrophil count (ANC) (\< 0.8 x 10\^3/ μL)
Severe organ dysfunction or life-threatening disease at screening
Presence of severe lupus kidney disease as defined by proteinuria above 2 g/day or equivalent using spot urine protein creatinine ratio, or serum creatinine greater than 2.0 mg/dL (176.84 µmol/L), or requiring immune-suppressive induction or maintenance treatment at screening
Receipt of live/attenuated vaccine within a 4-week period before first dosing
Any uncontrolled, co-existing serious disease, which in the opinion of the investigator will place the participant at risk for participation or interfere with evaluation for SLE-related symptoms
Non-lupus conditions such as asthma, gout or urticaria, requiring intermittent or chronic treatment with systemic CS
History of malignancy of any organ system other than localized basal cell carcinoma of the skin or in situ cervical cancer
Pregnant or nursing (lactating) women.
Women of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception while on study treatment and for 6 months after stopping of investigational drug.
Any surgical, medical, psychiatric or additional physical condition that may jeopardize participation in this study

Criterios de exclusión

Prior treatment with ianalumab

Ubicaciones

Novartis Investigative Site

La Plata, Buenos Aires, Argentina

Novartis Investigative Site

Quilmes, Buenos Aires, Argentina

Novartis Investigative Site

San Miguel, Buenos Aires, Argentina

Novartis Investigative Site

San Miguel, Tucumán Province, Argentina

Novartis Investigative Site

Caba, Argentina

Novartis Investigative Site

Caba, Argentina

Novartis Investigative Site

San Miguel de Tucumán, Argentina

A Randomized, Double-blind, Placebo-controlled Multicenter Phase 3 Study to Evaluate Efficacy, Safety and Tolerability of Ianalumab on Top of Standard-of-care Therapy in Patients With Systemic Lupus Erythematosus (SIRIUS-SLE 2)

Resumen

Descripción detallada

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

ianalumab

placebo

Ubicaciones

Novartis Investigative Site

Novartis Investigative Site

Novartis Investigative Site

Novartis Investigative Site

Novartis Investigative Site

Novartis Investigative Site

Novartis Investigative Site

Patrocinadores