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NCT05624749

PHASE3

Phase 3 Study to Evaluate Ianalumab on Top of Standard-of-care Therapy in Patients With Systemic Lupus Erythematosus (SIRIUS-SLE 2)

Sponsor: Novartis Pharmaceuticals

View on ClinicalTrials.gov

Summary

The trial will evaluate efficacy, safety and tolerability of ianalumab compared to placebo, given as monthly subcutaneous (s.c.) injection on top of standard-of-care (SoC) treatment in participants with active systemic lupus erythematosus (SLE).

Official title: A Randomized, Double-blind, Placebo-controlled Multicenter Phase 3 Study to Evaluate Efficacy, Safety and Tolerability of Ianalumab on Top of Standard-of-care Therapy in Patients With Systemic Lupus Erythematosus (SIRIUS-SLE 2)

Key Details

Gender

All

Age Range

12 Years - 100 Years

Study Type

INTERVENTIONAL

Enrollment

288

Start Date

2023-04-21

Completion Date

2029-04-09

Last Updated

2026-03-09

Healthy Volunteers

Conditions

Systemic Lupus Erythematosus

Interventions

DRUG

ianalumab

ianalumab s.c. monthly

DRUG

placebo

placebo s.c. monthly

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

Locations (95)

Pinnacle Research Group LLC

Anniston, Alabama, 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

Novartis Investigative Site

La Plata, Buenos Aires, Argentina

Novartis Investigative Site

Quilmes, Buenos Aires, Argentina

Novartis Investigative Site

San Miguel, Buenos Aires, Argentina

Novartis Investigative Site

San Miguel, Tucumán Province, Argentina

Novartis Investigative Site

Caba, Argentina

Novartis Investigative Site

Caba, Argentina

Novartis Investigative Site

San Miguel de Tucumán, Argentina

Novartis Investigative Site

Maroochydore, Queensland, Australia

Novartis Investigative Site

St Leonards, Australia

Novartis Investigative Site

Concepción, Bio Bio, Chile

Novartis Investigative Site

Valdivia, Los Ríos Region, Chile

Novartis Investigative Site

Santiago, RM, Chile

Novartis Investigative Site

Santiago, Santiago Metropolitan, Chile

Novartis Investigative Site

Medellín, Antioquia, Colombia

Novartis Investigative Site

Barranquilla, Atlántico, Colombia

Novartis Investigative Site

Barranquilla, Atlántico, Colombia

Novartis Investigative Site

Chía, Cundinamarca, Colombia

Novartis Investigative Site

Bucaramanga, Santander Department, Colombia

Novartis Investigative Site

Cali, Valle del Cauca Department, Colombia

Novartis Investigative Site

Bogotá, Colombia

Novartis Investigative Site

Grenoble, France

Novartis Investigative Site

Montpellier, France

Novartis Investigative Site

Paris, France

Novartis Investigative Site

Paris, France

Novartis Investigative Site

Paris, France

Novartis Investigative Site

Toulouse, France

Novartis Investigative Site

Toulouse, France

Novartis Investigative Site

Tours, France

Novartis Investigative Site

Freiburg im Breisgau, Baden-Wurttemberg, Germany

Novartis Investigative Site

Cologne, North Rhine-Westphalia, Germany

Novartis Investigative Site

Leipzig, Saxony, Germany

Novartis Investigative Site

Herne, Germany

Novartis Investigative Site

Mainz, Germany

Novartis Investigative Site

Ahmedabad, Gujarat, India

Novartis Investigative Site

Ahmedabad, Gujarat, India

Novartis Investigative Site

Kozhikode, Kerala, India

Novartis Investigative Site

Kolhāpur, Maharashtra, India

Novartis Investigative Site

Nagpur, Maharashtra, India

Novartis Investigative Site

Nashik, Maharashtra, India

Novartis Investigative Site

Pune, Maharashtra, India

Novartis Investigative Site

Pune, Maharashtra, India

Novartis Investigative Site

New Delhi, National Capital Territory of Delhi, India

Novartis Investigative Site

Dehradun, Uttarakhand, India

Novartis Investigative Site

New Delhi, India

Novartis Investigative Site

New Delhi, India

Novartis Investigative Site

Ancona, AN, Italy

Novartis Investigative Site

Cona, FE, Italy

Novartis Investigative Site

Padova, PD, Italy

Novartis Investigative Site

Pisa, PI, Italy

Novartis Investigative Site

Roma, RM, Italy

Novartis Investigative Site

Torino, TO, Italy

Novartis Investigative Site

Naples, Italy

Novartis Investigative Site

Seremban, Negeri Sembilan, Malaysia

Novartis Investigative Site

Ipoh, Perak, Malaysia

Novartis Investigative Site

Kuala Lumpur, Malaysia

Novartis Investigative Site

Selangor Darul Ehsan, Malaysia

Novartis Investigative Site

León, Guanajuato, Mexico

Novartis Investigative Site

Guadalajara, Jalisco, Mexico

Novartis Investigative Site

Mexico City, Mexico City, Mexico

Novartis Investigative Site

Morelia, Michoacán, Mexico

Novartis Investigative Site

Mérida, Yucatán, Mexico

Novartis Investigative Site

Mérida, Yucatán, Mexico

Novartis Investigative Site

México, Mexico

Novartis Investigative Site

Cluj-Napoca, Cluj, Romania

Novartis Investigative Site

Afumaţi, Ilfov, Romania

Novartis Investigative Site

Brasov, Romania

Novartis Investigative Site

Bucharest, Romania

Novartis Investigative Site

Gwangju Gwangyeoksi, Gwangju, South Korea

Novartis Investigative Site

Seoul, South Korea

Novartis Investigative Site

Seoul, South Korea

Novartis Investigative Site

Kaohsiung City, Taiwan

Novartis Investigative Site

Taichung, Taiwan

Novartis Investigative Site

Taichung, Taiwan

Novartis Investigative Site

Taipei, Taiwan

Novartis Investigative Site

Taipei, Taiwan

Novartis Investigative Site

Taoyuan District, Taiwan

Novartis Investigative Site

Leeds, West Yorkshire, United Kingdom

Novartis Investigative Site

Doncaster, United Kingdom

Novartis Investigative Site

Leicester, United Kingdom

Clinical Research Directory

Phase 3 Study to Evaluate Ianalumab on Top of Standard-of-care Therapy in Patients With Systemic Lupus Erythematosus (SIRIUS-SLE 2)

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (95)