Phase 3 Study to Evaluate Two Regimens of Ianalumab on Top of Standard-of-care Therapy in Patients With Systemic Lupus Erythematosus (SIRIUS-SLE 1)
NCT ID: NCT05639114
Last Updated: 2026-02-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
436 participants
INTERVENTIONAL
2023-03-02
2029-04-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Ianalumab s.c. monthly
Ianalumab s.c. monthly
Ianalumab
ianalumab s.c. monthly or quarterly
Ianalumab s.c. quarterly
Ianalumab s.c. quarterly
Ianalumab
ianalumab s.c. monthly or quarterly
Placebo s.c. monthly
placebo s.c. monthly
Placebo
placebo s.c. monthly
Interventions
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Ianalumab
ianalumab s.c. monthly or quarterly
Placebo
placebo s.c. monthly
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
Exclusion Criteria
12 Years
100 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Pinnacle Research Group Llc
Anniston, Alabama, United States
Providence Medical Center
Burbank, California, United States
University of California San Diego
La Jolla, California, United States
Keck School of Medicine
Los Angeles, California, United States
Millennium Clinical Trials
Westlake Village, California, United States
University of Colorado
Aurora, Colorado, United States
Yale University School Of Medicine
New Haven, Connecticut, United States
Clinical Res Of W Florida
Clearwater, Florida, United States
GNP Research
Cooper City, Florida, United States
University Of Miami
Miami, Florida, United States
Clinical Research of West Florida Inc
Tampa, Florida, United States
Parris and Associates Rheumatology
Lawrenceville, Georgia, United States
Chicago Clinical Research Inst
Chicago, Illinois, United States
Robert A Hozman MD SC
Skokie, Illinois, United States
Lake Cumberland Rheumatology and In
New Albany, Indiana, United States
Ochsner Clinic Foundation
Baton Rouge, Louisiana, United States
Henry Ford Health
Detroit, Michigan, United States
Univ of Nevada School of Med
Las Vegas, Nevada, United States
Sahni Rheumatology and Therapy
West Long Branch, New Jersey, United States
NYU Langone Health
Brooklyn, New York, United States
Paramount Med Rsrch and Consult LLC
Middleburg Heights, Ohio, United States
University Of Pittsburgh
Pittsburgh, Pennsylvania, United States
Prisma Health
Columbia, South Carolina, United States
Shelby Research LLC
Memphis, Tennessee, United States
Accurate Clinical Research Research
Baytown, Texas, United States
Novel Research LLC
Bellaire, Texas, United States
Texas Arthritis Center
El Paso, Texas, United States
Accurate Clinical Research
League City, Texas, United States
Epic Medical Research
Red Oak, Texas, United States
Novartis Investigative Site
San Miguel, Tucumán Province, Argentina
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San Miguel de Tucumán, , Argentina
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Fortaleza, Ceará, Brazil
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Vitória, Espírito Santo, Brazil
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Salvador, Estado de Bahia, Brazil
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Salvador, Estado de Bahia, Brazil
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Belo Horizonte, Minas Gerais, Brazil
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Curitiba, Paraná, Brazil
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Recife, Pernambuco, Brazil
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Niterói, Rio de Janeiro, Brazil
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Rio de Janeiro, Rio de Janeiro, Brazil
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Barretos, São Paulo, Brazil
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São Paulo, São Paulo, Brazil
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São Paulo, São Paulo, Brazil
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Salvador, , Brazil
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Plovdiv, , Bulgaria
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Rousse, , Bulgaria
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Sofia, , Bulgaria
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Calgary, Alberta, Canada
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Vancouver, British Columbia, Canada
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Hamilton, Ontario, Canada
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Toronto, Ontario, Canada
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Rimouski, Quebec, Canada
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Guangzhou, Guangdong, China
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Guangzhou, Guangdong, China
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Shantou, Guangdong, China
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Haikou, Hainan, China
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Zhuzhou, Hunan, China
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Nanjing, Jiangsu, China
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Suzhou, Jiangsu, China
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Nanchang, Jiangxi, China
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Pingxiang, Jiangxi, China
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Changchun, Jilin, China
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Linyi, Shandong, China
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Chengdu, Sichuan, China
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Ürümqi, Xinjiang, China
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Ningbo, Zhejiang, China
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Wenzhou, Zhejiang, China
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Beijing, , China
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Beijing, , China
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Shanghai, , China
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Xinxiang, , China
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Barranquilla, Atlántico, Colombia
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Bucaramanga, Santander Department, Colombia
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Cali, Valle del Cauca Department, Colombia
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Brno, , Czechia
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Prague, , Czechia
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Uherské Hradiště, , Czechia
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Guatemala City, , Guatemala
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Guatemala City, , Guatemala
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Székesfehérvár, Fejér, Hungary
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Budapest, , Hungary
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Budapest, , Hungary
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Gyula, , Hungary
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Zalaegerszeg, , Hungary
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Haifa, , Israel
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Ramat Gan, , Israel
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Nagoya, Aichi-ken, Japan
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Nagoya, Aichi-ken, Japan
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Sapporo, Hokkaido, Japan
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Yokohama, Kanagawa, Japan
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Yokohama, Kanagawa-ku, Japan
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Sendai, Miyagi, Japan
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Bunkyo Ku, Tokyo, Japan
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Bunkyo Ku, Tokyo, Japan
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Bunkyo-ku, Tokyo, Japan
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Chuo Ku, Tokyo, Japan
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Fuchū, Tokyo, Japan
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Itabashi-ku, Tokyo, Japan
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Meguro City, Tokyo, Japan
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Shinjuku-ku, Tokyo, Japan
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Fukuoka, , Japan
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Miyazaki, , Japan
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Osaka, , Japan
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Wroclaw, Lower Silesian Voivodeship, Poland
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Bydgoszcz, , Poland
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Bydgoszcz, , Poland
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Bytom, , Poland
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Lodz, , Poland
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Warsaw, , Poland
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Warsaw, , Poland
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Braga, , Portugal
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Lisbon, , Portugal
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Lisbon, , Portugal
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Lisbon, , Portugal
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Vila Nova de Gaia, , Portugal
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Bratislava, , Slovakia
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Košice, , Slovakia
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Košice, , Slovakia
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Pretoria, Gauteng, South Africa
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Cape Town, Western Cape, South Africa
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Cape Town, Western Cape, South Africa
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Stellenbosch, Western Cape, South Africa
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Umhlanga, , South Africa
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Santiago Compostela, A Coruna, Spain
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Elche, Alicante, Spain
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Badalona, Barcelona, Spain
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Santander, Cantabria, Spain
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Barcelona, Catalonia, Spain
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San Sebastian Reyes, Madrid, Spain
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Pamplona, Navarre, Spain
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Vigo, Pontevedra, Spain
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San Cristóbal de La Laguna, Santa Cruz De Tenerife, Spain
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Barcelona, , Spain
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Madrid, , Spain
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Valencia, , Spain
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Valladolid, , Spain
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Songkhla, Hat Yai, Thailand
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Muang, Thailand, Thailand
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Bangkok, , Thailand
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Bangkok, , Thailand
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Ankara, Bilkent Cankaya, Turkey (Türkiye)
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Ankara, Etlik, Turkey (Türkiye)
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Istanbul, Fatih, Turkey (Türkiye)
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Istanbul, Umraniye, Turkey (Türkiye)
Countries
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Other Identifiers
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2022-002691-36
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2023-508498-97-00
Identifier Type: OTHER
Identifier Source: secondary_id
CVAY736F12301
Identifier Type: -
Identifier Source: org_study_id
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