Study Description
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). 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)
Interventions
ianalumab
placebo
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- Prior treatment with ianalumab
- History 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).
IV) Traditional Chinese medicines administered within 30 days prior to randomization
- 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
Study Location
Novartis Investigative Site
Recruiting
San Miguel de Tucuman,Tucuman,T4000cbc,Argentina
Novartis Investigative Site
Recruiting
San Miguel,Buenos Aires,1663,Argentina
Novartis Investigative Site
Recruiting
Tucuman,4000,Argentina
Novartis Investigative Site
Recruiting
Buenos Aires,C1430egf,Argentina
Novartis Investigative Site
Recruiting
Ciudad Autonoma de Bs As,Buenos Aires,C1015abo,Argentina
Novartis Investigative Site
Recruiting
La Plata,Buenos Aires,B1900awt,Argentina
Novartis Investigative Site
Recruiting
Maroochydore,Queensland,4558,Australia
Novartis Investigative Site
Recruiting
St Leonards,New South Wales,2065,Australia
Novartis Investigative Site
Recruiting
Concepcion,6740,Chile
Novartis Investigative Site
Recruiting
Santiago,7500710,Chile
Novartis Investigative Site
Recruiting
Valdivia,Los Rios,5110683,Chile
Novartis Investigative Site
Recruiting
Santiago,RM,7500588,Chile
Novartis Investigative Site
Recruiting
Cundinamarca,111121,Colombia
Novartis Investigative Site
Recruiting
Bogota,111611,Colombia
Novartis Investigative Site
Recruiting
Medellin,Antioquia,050001,Colombia
Novartis Investigative Site
Recruiting
Bucaramanga,Santander,0001,Colombia
Novartis Investigative Site
Recruiting
Cali,Valle Del Cauca,760046,Colombia
Novartis Investigative Site
Recruiting
Barranquilla,Atlantico,080002,Colombia
Novartis Investigative Site
Recruiting
Barranquilla,080020,Colombia
Novartis Investigative Site
Recruiting
Tours,37044,France
Novartis Investigative Site
Recruiting
Montpellier Cedex 5,34295,France
Novartis Investigative Site
Recruiting
Paris 13,75651,France
Novartis Investigative Site
Recruiting
Angers Cedex 9,49933,France
Novartis Investigative Site
Recruiting
Grenoble,38043,France
Novartis Investigative Site
Recruiting
Paris,75014,France
Novartis Investigative Site
Recruiting
Toulouse 4,31054,France
Novartis Investigative Site
Recruiting
Paris,75018,France
Novartis Investigative Site
Recruiting
Toulouse,31400,France
Novartis Investigative Site
Recruiting
Berlin,13353,Germany
Novartis Investigative Site
Recruiting
Erlangen,91056,Germany
Novartis Investigative Site
Recruiting
Aachen,52074,Germany
Novartis Investigative Site
Recruiting
Freiburg,79106,Germany
Novartis Investigative Site
Recruiting
Herne,44649,Germany
Washington Univ School Of Medicine
Recruiting
Saint Louis,Missouri,63110,United States
Reema Syed
University of Calif Irvine Med Cntr
Recruiting
Irvine,California,92660,United States
Sheetal Desai
Ahmed Arif Medical Research Center
Recruiting
Grand Blanc,Michigan,48439,United States
Ali Karrar
Pinnacle Research Group LLC .
Recruiting
Anniston,Alabama,36207-5710,United States
Vishala L Chindalore
Integral Rheumatology and Immunology Specialists IRIS
Recruiting
Plantation,Florida,33324,United States
Guillermo Valenzuela
Emory University .
Recruiting
Atlanta,Georgia,30307,United States
Anum Jalal
Arezou Khosroshahi
Thomas Jefferson University Einstein Healthcare Network
Recruiting
Philadelphia,Pennsylvania,19107,United States
Arya Patel
Irene Tan
Accurate Clinical Research Research
Recruiting
Lake Charles,Louisiana,70601,United States
Enrique Mendez
Jacob Seep
West Tennessee Research Institute
Recruiting
Jackson,Tennessee,38305,United States
Jacob A. Aelion
Homestead Assoc In Research Inc
Recruiting
Homestead,Florida,33033,United States
Gilberto Seco
UMC New Orleans Nephrologist
Recruiting
New Orleans,Louisiana,70112,United States
Jasmine McGary
Stephen Lindsey
Advanced Medical Research
Recruiting
La Palma,California,90623,United States
Gerald Ho
Novel Research LLC
Recruiting
Bellaire,Texas,77401,United States
Hina Arshad
Wajeeha Yousaf
University Of Maryland Rheumatology
Recruiting
Baltimore,Maryland,21201,United States
Emem Adanga
Violeta Rus
Illinois Bone And Joint Institute
Recruiting
Hinsdale,Illinois,60521,United States
Angela R Crowley
Swarnika Sampat
Worldwide Contacts
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