Last updated 32 days ago
Phase 3 Study to Evaluate Ianalumab on Top of Standard-of-care Therapy in Patients With Systemic Lupus Erythematosus (SIRIUS-SLE 2)
280 patients around the world
Available in United States, 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)
Novartis Pharmaceuticals
6Research sites
280Patients around the world
This study is for people with
Lupus
Systemic lupus erythematosus
Requirements for the patient
From 12 Years
All Gender
Medical requirements
- 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 according to 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, OrBILAG-2004 level 'B' disease in ≥ 2 organ systemsWeigh at least 35 kg at screening
- Prior treatment with ianalumabHistory of receiving following treatment I) high dose CS, calcineurin inhibitors, JAK or other kinase inhibitors or other DMARD (except as listed in inclusion criteria) administered within 12 weeks prior to screening II) cyclophosphamide or biologics such as immunoglobulins (intravenous or s.c.), plasmapheresis, anti-type I interferon receptor biologic agents, anti-CD40 agents, CTLA4-Fc Ig or B-cell activating factor (BAFF)-targeting agents administered within 24 weeks prior to screening; belimumab administered within 12 weeks prior to screening. III) any B cell-depleting therapies, other than ianalumab administered within 36 weeks prior to randomization or as long as B cell count is less than the lower limit of normal or baseline value prior to receipt of B cell-depleting therapy (whichever is lower).Active viral, bacterial or other infections requiring systemic treatment at the time of screening or randomization or history of recurrent clinically significant infectionChronic infection with hepatitis B virus (HBV) or hepatitis C virus (HCV)Evidence of active tuberculosis infectionHistory of primary or secondary immunodeficiency, including a positive human immunodeficiency virus (HIV) test result at screeningAny 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 anaemiaAbsolute neutrophil count (ANC) (< 0.8 x 10^3/ μL)Severe organ dysfunction or life-threatening disease at screeningPresence 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 exceeding protocol-defined limits prior to randomizationReceipt of live/attenuated vaccine within a 4-week period before first dosingAny 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 symptomsNon-lupus conditions such as asthma, gout or urticaria, requiring intermittent or chronic treatment with systemic CSHistory of malignancy of any organ system other than localized basal cell carcinoma of the skin or in situ cervical cancerPregnant 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
Sites
Clínica Adventista Belgrano - CABA - Buenos Aires
Recruiting
Organización Médica de Investigación (OMI)
Recruiting
Centro Integral de Medicina Respiratoria (CIMER) - Tucumán
Recruiting
Hospital Italiano de La Plata
Recruiting
Centro Dermatológico Schejtman
Recruiting
Centro de Investigaciones Médicas Tucumán
Recruiting
StudySIRIUS-SLE 2
SponsorNovartis Pharmaceuticals
Conditions
Systemic lupus erythematosus
Requirements
From 12 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT05624749
