Study Description
The trial will evaluate efficacy, safety and tolerability of two regimens of ianalumab compared to placebo, given as monthly or quarterly subcutaneous (s.c.) injection on top of standard-of-care (SoC) treatment in participants with active systemic lupus erythematosus (SLE).
A randomized, double-blind, parallel group, placebo-controlled multicenter phase 3 study to evaluate efficacy, safety and tolerability of two regimens of ianalumab on top of standard-of-care therapy in patients with systemic lupus erythematosus (SIRIUS-SLE 1)
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
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São Paulo,SP,01244-030,Brazil
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Barretos,Sao Paulo,14784 400,Brazil
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São Paulo,SP,04038-002,Brazil
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Niteroi,RJ,24020 096,Brazil
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Salvador,BA,40150 150,Brazil
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Salvador,40301-155,Brazil
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Belo Horizonte,MG,30150-221,Brazil
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Curitiba,PR,80030-110,Brazil
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Rio de Janeiro,RJ,22211 230,Brazil
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Vitoria,ES,29055 450,Brazil
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Brasilia,DF,71635-580,Brazil
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Ruse,7002,Bulgaria
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Plovdiv,4002,Bulgaria
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Rimouski,Quebec,G5L 5T1,Canada
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Haikou,Hainan,570311,China
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Zhejiang,315016,China
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Guangzhou,Guangdong,510000,China
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Nanjing,Jiangsu,210008,China
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Zhuzhou,Hunan,412000,China
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Chang Chun,Jilin,130021,China
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Urumqi,Xinjiang,830001,China
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Beijing,100069,China
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Chengdu,Sichuan,610041,China
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Linyi,Shandong,276000,China
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Beijing,100730,China
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Wuhan,430022,China
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Shanghai,200040,China
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Baotou,Inner Mongolia,014010,China
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Shanghai,200127,China
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Suzhou,Jiangsu,215004,China
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Shantou,Guangdong,515041,China
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Guangzhou,Guangdong,51000,China
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Pingxiang,Jiangxi,337000,China
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Nanchang,Jiangxi,330006,China
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Uherske Hradiste,686 01,Czech Republic
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Praha 2,128 50,Czech Republic
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Brno,63800,Czech Republic
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Guatemala,01010,Guatemala
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Guatemala City,01011,Guatemala
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Gyula,5700,Hungary
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Szekesfehervar,Fejer,8000,Hungary
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Ramat Gan,52621,Israel
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Haifa,3109601,Israel
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Ichikawa,Chiba,272-8516,Japan
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Meguro,Tokyo,153-8515,Japan
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Sapporo city,Hokkaido,060 8648,Japan
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Fuchu,Tokyo,183-8524,Japan
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Ono,Hyogo,675-1327,Japan
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Kawasaki-city,Kanagawa,216-8511,Japan
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Miyazaki-city,Miyazaki,889-1692,Japan
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Fukuoka,815-8555,Japan
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Nagoya,Aichi,457 8510,Japan
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Chuo ku,Tokyo,104-8560,Japan
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Yokohama-city,Kanagawa,236-0004,Japan
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Gifu,500-8717,Japan
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Nagoya,Aichi,457-8511,Japan
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Yokohama,Kanagawa,222-0036,Japan
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Kurashiki,Okayama,710-8522,Japan
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Warszawa,00-874,Poland
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Rzeszow,35 301,Poland
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Warszawa,04141,Poland
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Wroclaw,Dolnoslaskie,52-210,Poland
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Bydgoszcz,85 168,Poland
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Bydgoszcz,85-065,Poland
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Bytom,41 902,Poland
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Lodz,90-338,Poland
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Leiria,2410-187,Portugal
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Lisboa,1349 019,Portugal
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Lisboa,1050-034,Portugal
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Lisboa,1649-035,Portugal
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Braga,4710243,Portugal
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Singapore,119260,Singapore
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Singapore,169608,Singapore
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Singapore,308433,Singapore
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Bratislava,81109,Slovakia
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Bratislava,85101,Slovakia
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Piestany,92101,Slovakia
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Kosice,04011,Slovakia
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Cape Town,7405,South Africa
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Pretoria,0002,South Africa
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Stellenbosch,7600,South Africa
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Barcelona,Catalunya,08035,Spain
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Madrid,28034,Spain
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La Laguna,Santa Cruz De Tenerife,38320,Spain
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Elche,Alicante,03203,Spain
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Badalona,Catalunya,08916,Spain
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Merida,Extremadura,06800,Spain
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Valladolid,Castilla Y Leon,47012,Spain
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Pamplona,Navarra,31008,Spain
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Vigo,Pontevedra,36200,Spain
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San Sebastian de los Reyes,Madrid,28702,Spain
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Vitoria Gasteiz,Pais Vasco,01009,Spain
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Santander,Cantabria,39008,Spain
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Barcelona,Catalunya,08003,Spain
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Santiago De Compostela,Galicia,15706,Spain
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El Palmar,Murcia,30120,Spain
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Bangkok,10400,Thailand
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Songkhla,Hat Yai,90110,Thailand
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Chiang Mai,50200,Thailand
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Bangkok,10700,Thailand
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Aydin,09100,Turkey
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Etlik / Ankara,06018,Turkey
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Izmir,35620,Turkey
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Konya,42080,Turkey
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Ankara,06500,Turkey
Robert A Hozman MD SC
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Skokie,(847-727-2743) -- Robert Hozman,60076 - Illinois,United States
Epic Medical Research
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Red Oak,Shay Hart (469-206-2642) email: [email protected] -- Sunny Patel,75154 - Texas,United States
STAT Research Inc .
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Dayton,Laura Earle (937-223-4229) email: [email protected] -- Sanford Wolfe,45402 - Ohio,United States
Henry Ford Health
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Detroit,Alireza Meysami,48202 - Michigan,United States
Ochsner Clinic Foundation
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Baton Rouge,Magen Parker (225-761-5481) email: [email protected] -- Saravanan Thiagarajan,70836 - Louisiana,United States
University of California San Diego .
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La Jolla,(+1 858 657 7040) -- Chelsey J F Smith,92093 - California,United States
Keck School of Medicine Keck Medicine of USC
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Los Angeles,Sara Madrigal (323-442-1963) email: [email protected] -- William Stohl,90033 - California,United States
University of Colorado University of Colorado Denver
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Aurora,Prakriti Joshee email: [email protected] -- Christopher Striebich,80045 - Colorado,United States
Lake Cumberland Rheumatology and In
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New Albany,Kara Lay email: [email protected] -- Scott Lewis,47150 - Indiana,United States
Parris and Associates Rheumatology
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Lawrenceville,(+17709621616#8334) -- Glenn Parris,30044 - Georgia,United States
Millennium Clinical Trials
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Simi Valley,Elvira Lindwall,93065 - California,United States
Providence Medical Center
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Burbank,Maria Hernandez (818-869-7600) email: [email protected] -- Sue Chung,91505 - California,United States
Accurate Clinical Research Research
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League City,Sabeen Najam,77573 - Texas,United States
Ramesh C Gupta MD Memphis TN
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Memphis,Tanuja Katiki (901-681-9670) email: [email protected] -- Ramesh C Gupta,38119 - Tennessee,United States
Clinical Research of West Florida
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Clearwater,(813-466-0078) -- Robert Levin,33765 - Florida,United States
Worldwide Contacts
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