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
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Barretos,Sao Paulo,14784 400,Brazil
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Salvador,BA,40150 150,Brazil
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Sao Paulo,SP,01244-030,Brazil
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Vitoria,ES,29055 450,Brazil
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Sao Paulo,SP,04038-002,Brazil
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Belo Horizonte,MG,30150-221,Brazil
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Salvador,40301-155,Brazil
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Curitiba,PR,80030-110,Brazil
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Niteroi,RJ,24020 096,Brazil
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Rio de Janeiro,RJ,22211 230,Brazil
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Sofia,1680,Bulgaria
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Plovdiv,4002,Bulgaria
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Ruse,7002,Bulgaria
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Vancouver,British Columbia,V5z 1l7,Canada
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Hamilton,Ontario,L8n 3z5,Canada
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Rimouski,Quebec,G5l 5t1,Canada
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Urumqi,Xinjiang,830001,China
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Nanchang,Jiangxi,330006,China
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Shantou,Guangdong,515041,China
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Beijing,100069,China
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Pingxiang,Jiangxi,337000,China
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Haikou,Hainan,570311,China
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Beijing,100730,China
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Chang Chun,Jilin,130021,China
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Zhuzhou,Hunan,412000,China
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Shanghai,200040,China
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Linyi,Shandong,276000,China
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Baotou,Inner Mongolia,014010,China
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Shanghai,200127,China
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Chengdu,Sichuan,610041,China
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Nanjing,Jiangsu,210008,China
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Zhejiang,315016,China
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Guangzhou,Guangdong,510000,China
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Suzhou,Jiangsu,215004,China
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Guangzhou,Guangdong,510080,China
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Praha 2,128 50,Czechia
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Uherske Hradiste,686 01,Czechia
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Brno,63800,Czechia
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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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Haifa,3109601,Israel
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Ramat Gan,52621,Israel
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Fuchu-city,Tokyo,183-8561,Japan
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Suita,Osaka,565 0871,Japan
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Osaka,545-8586,Japan
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Sapporo city,Hokkaido,060 8648,Japan
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Fuchu,Tokyo,183-8524,Japan
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Iruma-gun,Saitama,350-0495,Japan
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Ono,Hyogo,675-1327,Japan
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Meguro,Tokyo,153-8515,Japan
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Bunkyo ku,Tokyo,113 8655,Japan
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Kawasaki,Kanagawa,216-8511,Japan
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Chiba,2608677,Japan
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Nagoya,Aichi,457 8510,Japan
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Bunkyo ku,Tokyo,113-8431,Japan
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Yokohama-city,Kanagawa,236-0004,Japan
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Fukuoka,815-8555,Japan
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Nagoya,Aichi,457-8511,Japan
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Bunkyo-ku,Tokyo,113-8519,Japan
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Yokohama,Kanagawa,222-0036,Japan
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Gifu,500-8717,Japan
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Ichikawa,Chiba,272 8516,Japan
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Chuo ku,Tokyo,104 8560,Japan
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Kurashiki,Okayama,710-8522,Japan
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Miyazaki,889-1692,Japan
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Fukuoka city,Fukuoka,812-8582,Japan
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Rzeszow,35 301,Poland
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Warszawa,00-874,Poland
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Wroclaw,Dolnoslaskie,52-210,Poland
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Warszawa,04141,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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Lisboa,1649 035,Portugal
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Braga,4710243,Portugal
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Leiria,2410-104,Portugal
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Lisboa,1349-019,Portugal
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Singapore,119074,Singapore
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Singapore,169608,Singapore
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Singapore,S308433,Singapore
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Bratislava,85101,Slovakia
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Kosice,04011,Slovakia
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Piestany,92101,Slovakia
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Cape Town,7405,South Africa
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Panorama,7500,South Africa
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Pretoria,0002,South Africa
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Stellenbosch,7600,South Africa
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Umhlanga,4320,South Africa
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Madrid,28034,Spain
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Santiago De Compostela,Galicia,15706,Spain
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Valladolid,Castilla Y Leon,47012,Spain
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San Sebastian de los Reyes,Madrid,28702,Spain
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Badalona,Catalunya,08916,Spain
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Pamplona,Navarra,31008,Spain
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Barcelona,Catalunya,08003,Spain
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Vitoria Gasteiz,Pais Vasco,01009,Spain
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Barcelona,Catalunya,08035,Spain
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Vigo,Pontevedra,36200,Spain
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Valencia,Comunidad Valenciana,46014,Spain
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Elche,Alicante,03203,Spain
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Etlik Ankara,06018,Turkey
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Aydin,09100,Turkey
Epic Medical Research
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Red Oak,Texas,75154,United States
Sunny Patel
Keck School of Medicine
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Los Angeles,California,90033,United States
William Stohl
University Of Miami
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Miami,Florida,33136,United States
Maria Fernanda Carpintero
NYU Langone Health
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Brooklyn,New York,11201,United States
David Goddard
Noemi Peralta
Providence Medical Center
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Burbank,California,91505,United States
Sue Chung
STAT Research Inc
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Dayton,Ohio,45402,United States
Sanford Wolfe
Lake Cumberland Rheumatology and In
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New Albany,Indiana,47150,United States
Scott Lewis
Kara Lay
University of Colorado
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Aurora,Colorado,80045,United States
Christopher Striebich
Prakriti Joshee
Millennium Clinical Trials
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Westlake Village,California,91361,United States
Elvira Lindwall
Paramount Med Rsrch and Consult LLC
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Middleburg Heights,Ohio,44130,United States
Isam Diab
Ochsner Clinic Foundation
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Baton Rouge,Louisiana,70836,United States
Saravanan Thiagarajan
Parris and Associates Rheumatology
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Lawrenceville,Georgia,30044,United States
Glenn Parris
Medical Center Main Campus
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Cleveland,Ohio,44109,United States
Stanley Ballou
Clinical Res Of W Florida
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Clearwater,Florida,33765,United States
Robert Levin
Yale University School Of Medicine
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New Haven,Connecticut,06520,United States
Fotios Koumpouras
University of California San Diego
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La Jolla,California,92093,United States
Chelsey J F Smith
Prisma Health
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Columbia,South Carolina,29203,United States
Laketa Hillman-Daughety
Sunita Paudyal
Henry Ford Health
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Detroit,Michigan,48202,United States
Alireza Meysami
Robert A Hozman MD SC
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Skokie,Illinois,60076,United States
Robert Hozman
Univ of Nevada School of Med
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Las Vegas,Nevada,89102,United States
Walter Winn Chatham
Accurate Clinical Research Research
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Baytown,Texas,77521,United States
Sabeen Najam
GNP Research
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Hollywood,Florida,33024,United States
Mark Jaffe
Sahni Rheumatology and Therapy
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West Long Branch,New Jersey,07764,United States
Kiren Sahni
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