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
Recruiting
Belo Horizonte,MG,30150-221,Brazil
Novartis Investigative Site
Recruiting
Salvador,BA,40150 150,Brazil
Novartis Investigative Site
Recruiting
Curitiba,PR,80030-110,Brazil
Novartis Investigative Site
Recruiting
Salvador,40301-155,Brazil
Novartis Investigative Site
Recruiting
Niteroi,RJ,24020 096,Brazil
Novartis Investigative Site
Recruiting
Sao Paulo,SP,01244-030,Brazil
Novartis Investigative Site
Recruiting
Vitoria,ES,29055 450,Brazil
Novartis Investigative Site
Recruiting
Sao Paulo,SP,04038-002,Brazil
Novartis Investigative Site
Recruiting
Rio de Janeiro,RJ,22211 230,Brazil
Novartis Investigative Site
Recruiting
Barretos,Sao Paulo,14784 400,Brazil
Novartis Investigative Site
Recruiting
Plovdiv,4002,Bulgaria
Novartis Investigative Site
Recruiting
Sofia,1680,Bulgaria
Novartis Investigative Site
Recruiting
Ruse,7002,Bulgaria
Novartis Investigative Site
Recruiting
Toronto,Ontario,M5t 2s8,Canada
Novartis Investigative Site
Recruiting
Vancouver,British Columbia,V5z 1l7,Canada
Novartis Investigative Site
Recruiting
Rimouski,Quebec,G5l 5t1,Canada
Novartis Investigative Site
Recruiting
Hamilton,Ontario,L8n 3z5,Canada
Novartis Investigative Site
Recruiting
Suzhou,Jiangsu,215004,China
Novartis Investigative Site
Recruiting
Nanjing,Jiangsu,210008,China
Novartis Investigative Site
Recruiting
Guangzhou,Guangdong,510000,China
Novartis Investigative Site
Recruiting
Guangzhou,Guangdong,510080,China
Novartis Investigative Site
Recruiting
Zhuzhou,Hunan,412000,China
Novartis Investigative Site
Recruiting
Haikou,Hainan,570311,China
Novartis Investigative Site
Recruiting
Shantou,Guangdong,515041,China
Novartis Investigative Site
Recruiting
Baotou,Inner Mongolia,014010,China
Novartis Investigative Site
Recruiting
Nanchang,Jiangxi,330006,China
Epic Medical Research
Recruiting
Red Oak,Texas,75154,United States
Sunny Patel
Ramesh C Gupta MD Memphis TN
Recruiting
Memphis,Tennessee,38119,United States
Ramesh C Gupta
University of Colorado University of Colorado Denver
Recruiting
Aurora,Colorado,80045,United States
Christopher Striebich
Katherine Deluca
Paramount Med Rsrch and Consult LLC .
Recruiting
Middleburg Heights,Ohio,44130,United States
Isam Diab
Lake Cumberland Rheumatology and In
Recruiting
New Albany,Indiana,47150,United States
Scott Lewis
Kara Lay
STAT Research Inc .
Recruiting
Dayton,Ohio,45402,United States
Sanford Wolfe
GNP Research
Recruiting
Hollywood,Florida,33024,United States
Mark Jaffe
Medical Center Main Campus
Recruiting
Cleveland,Ohio,44109,United States
Stanley Ballou
University Of Miami
Recruiting
Miami,Florida,33136,United States
Maria Fernanda Carpintero
Accurate Clinical Research Research
Recruiting
Baytown,Texas,77521,United States
Sabeen Najam
Parris and Associates Rheumatology
Recruiting
Lawrenceville,Georgia,30044,United States
Glenn Parris
Univ of Nevada School of Med Research
Recruiting
Las Vegas,Nevada,89102,United States
Walter Winn Chatham
Henry Ford Health
Recruiting
Detroit,Michigan,48202,United States
Alireza Meysami
Clinical Res Of W Florida
Recruiting
Clearwater,Florida,33765,United States
Robert Levin
Millennium Clinical Trials
Recruiting
Westlake Village,California,91361,United States
Elvira Lindwall
Keck School of Medicine Keck Medicine of USC
Recruiting
Los Angeles,California,90033,United States
William Stohl
Sahni Rheumatology and Therapy
Recruiting
West Long Branch,New Jersey,07764,United States
Kiren Sahni
Yale University School Of Medicine Research
Recruiting
New Haven,Connecticut,06520,United States
Fotios Koumpouras
Providence Medical Center
Recruiting
Burbank,California,91505,United States
Sue Chung
University of California San Diego .
Recruiting
La Jolla,California,92093,United States
Chelsey J F Smith
Ochsner Clinic Foundation
Recruiting
Baton Rouge,Louisiana,70836,United States
Saravanan Thiagarajan
Worldwide Contacts
If the location of your choosing does not feature any contact detail, please reach out using the information below.