Phase 3 Study to Evaluate Ianalumab on Top of Standard-of-care Therapy in Patients With Systemic Lupus Erythematosus (SIRIUS-SLE 2)
NCT ID: NCT05624749
Last Updated: 2025-12-22
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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RECRUITING
PHASE3
280 participants
INTERVENTIONAL
2023-04-21
2029-04-20
Brief Summary
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Detailed Description
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Conditions
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Keywords
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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
placebo s.c. monthly
placebo s.c. monthly
placebo
placebo s.c. monthly
Interventions
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ianalumab
ianalumab s.c. monthly
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
University of Calif Irvine Med Cntr
Irvine, California, United States
Advanced Medical Research
La Palma, California, United States
University of California LA
Los Angeles, California, United States
Homestead Assoc In Research Inc
Homestead, Florida, United States
IRIS Research and Development
Plantation, Florida, United States
Emory University
Atlanta, Georgia, United States
Willow Rheumatology Wellness
Willowbrook, Illinois, United States
Bluegrass Community Research Inc
Lexington, Kentucky, United States
Accurate Clinical Research
Lake Charles, Louisiana, United States
UMC New Orleans
New Orleans, Louisiana, United States
University Of Maryland
Baltimore, Maryland, United States
Ahmed Arif Medical Research Center
Grand Blanc, Michigan, United States
Washington Univ School Of Medicine
St Louis, Missouri, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
West Tennessee Research Institute
Jackson, Tennessee, United States
Novel Research LLC
Bellaire, Texas, United States
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La Plata, Buenos Aires, Argentina
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Quilmes, Buenos Aires, Argentina
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San Miguel, Buenos Aires, Argentina
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San Miguel, Tucumán Province, Argentina
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Caba, , Argentina
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Caba, , Argentina
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San Miguel de Tucumán, , Argentina
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Maroochydore, Queensland, Australia
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Victoria Park, Western Australia, Australia
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St Leonards, , Australia
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Concepción, Bio Bio, Chile
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Valdivia, Los Ríos Region, Chile
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Santiago, RM, Chile
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Santiago, Santiago Metropolitan, Chile
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Medellín, Antioquia, Colombia
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Barranquilla, Atlántico, Colombia
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Barranquilla, Atlántico, Colombia
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Chía, Cundinamarca, Colombia
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Bucaramanga, Santander Department, Colombia
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Cali, Valle del Cauca Department, Colombia
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Bogotá, , Colombia
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Angers, , France
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Clermont-Ferrand, , France
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Grenoble, , France
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Lyon, , France
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Montpellier, , France
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Paris, , France
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Paris, , France
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Paris, , France
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Toulouse, , France
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Toulouse, , France
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Tours, , France
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Freiburg im Breisgau, Baden-Wurttemberg, Germany
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Cologne, North Rhine-Westphalia, Germany
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Leipzig, Saxony, Germany
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Aachen, , Germany
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Berlin, , Germany
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Erlangen, , Germany
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Herne, , Germany
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Mainz, , Germany
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München, , Germany
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Ahmedabad, Gujarat, India
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Ahmedabad, Gujarat, India
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Kozhikode, Kerala, India
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Kolhāpur, Maharashtra, India
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Nagpur, Maharashtra, India
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Nashik, Maharashtra, India
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Pune, Maharashtra, India
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Pune, Maharashtra, India
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New Delhi, National Capital Territory of Delhi, India
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Secunderabad, Telangana, India
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Dehradun, Uttarakhand, India
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New Delhi, , India
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New Delhi, , India
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Puducherry, , India
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Visakhapatnam, , India
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Ancona, AN, Italy
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Caserta, CE, Italy
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Cona, FE, Italy
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Milan, MI, Italy
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Padua, PD, Italy
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Pisa, PI, Italy
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Roma, RM, Italy
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Torino, TO, Italy
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Napoli, , Italy
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Seremban, Negeri Sembilan, Malaysia
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Ipoh, Perak, Malaysia
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Kuching, Sarawak, Malaysia
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Petaling Jaya, Selangor, Malaysia
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Kuala Lumpur, , Malaysia
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Selangor Darul Ehsan, , Malaysia
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León, Guanajuato, Mexico
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Guadalajara, Jalisco, Mexico
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Mexico City, Mexico City, Mexico
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Morelia, Michoacán, Mexico
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Mérida, Yucatán, Mexico
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Mérida, Yucatán, Mexico
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México, , Mexico
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Cluj-Napoca, Cluj, Romania
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Afumaţi, Ilfov, Romania
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Brasov, , Romania
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Bucharest, , Romania
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Gwangju Gwangyeoksi, Gwangju, South Korea
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Daejeon, Korea, South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Kaohsiung City, , Taiwan
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Taichung, , Taiwan
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Taichung, , Taiwan
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Taipei, , Taiwan
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Taipei, , Taiwan
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Taoyuan District, , Taiwan
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Doncaster, , United Kingdom
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Leicester, , United Kingdom
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London, , United Kingdom
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London, , United Kingdom
Countries
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Central Contacts
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Novartis Pharmaceuticals
Role: CONTACT
Phone: +41613241111
Facility Contacts
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Ruby Fields
Role: primary
Ahmad Walid Roshan
Role: primary
Ray Beshai
Role: primary
Aima Ohiwerei
Role: primary
Mario Hernandez
Role: primary
Jhon Galindo
Role: primary
Toby Amoss
Role: primary
Lubna Ali
Role: primary
Jacob Seep
Role: primary
Cathryn Leggio
Role: primary
Vinh Nguyen
Role: primary
Iman Abdelrahman
Role: primary
Rebecca Sweeney
Role: primary
Stacey Carmody
Role: primary
Rachel Williams
Role: primary
Hassan Khan
Role: primary
Other Identifiers
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CVAY736F12302
Identifier Type: -
Identifier Source: org_study_id
2022-002690-29
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2023-508499-12-00
Identifier Type: OTHER
Identifier Source: secondary_id