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

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: Systemic Lupus Erythematosus

In brief

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).

Key facts

Study ID

NCT05624749

Run by

Novartis Pharmaceuticals

People needed

288

Starts

2023-04-21

Expected to finish

2029-04-09

Last updated by the study team

2026-07-24

Who can join

Age: 12 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Novartis Investigative Site — Paris, France
• Novartis Investigative Site — Toulouse, France
• Novartis Investigative Site — Toulouse, France
• Novartis Investigative Site — Tours, France
• 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
• 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 — Paris, France

Full record on ClinicalTrials.gov

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