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)

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 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).

Key facts

Study ID

NCT05639114

Run by

Novartis Pharmaceuticals

People needed

436

Starts

2023-03-02

Expected to finish

2029-03-23

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

• Providence Medical Center — Burbank, California, United States
• University of California San Diego — La Jolla, 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
• 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
• Henry Ford Health — Detroit, Michigan, United States
• Sahni Rheumatology and Therapy — West Long Branch, New Jersey, United States
• Paramount Med Rsrch and Consult LLC — Middleburg Heights, Ohio, United States
• University Of Pittsburgh — Pittsburgh, Pennsylvania, United States
• Shelby Research LLC — Memphis, Tennessee, United States
• Accurate Clinical Research Research — Baytown, Texas, United States
• Novel Research LLC — Bellaire, 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
• Novartis Investigative Site — San Miguel de Tucumán, Argentina
• Novartis Investigative Site — Fortaleza, Ceará, Brazil
• Pinnacle Research Group Llc — Anniston, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.