🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in the USA / NCT05639114
Active, not recruiting Phase 3

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)

NCT05639114 · tracked via the Priya Life Science USA tracker
Sponsor
Novartis Pharmaceuticals
Phase
Phase 3
Started
2023-03-02
Last updated
2026-08-21

Condition(s) studied

Systemic Lupus Erythematosus

Investigational drug(s) / intervention(s)

Ianalumab →Placebo

Ianalumab: ianalumab s.c. monthly or quarterly

Placebo: placebo s.c. monthly

Study summary

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).

Eligibility

Sex
ALL
Min age
12 Years
Max age
100 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (135)

FacilityCityRegionStatus
Pinnacle Research Group Llc Anniston Alabama
Providence Medical Center Burbank California
University of California San Diego La Jolla California
Millennium Clinical Trials Westlake Village California
University of Colorado Aurora Colorado
Yale University School Of Medicine New Haven Connecticut
Clinical Res Of W Florida Clearwater Florida
GNP Research Cooper City Florida
Clinical Research of West Florida Inc Tampa Florida
Parris and Associates Rheumatology Lawrenceville Georgia
Chicago Clinical Research Inst Chicago Illinois
Robert A Hozman MD SC Skokie Illinois
Lake Cumberland Rheumatology and In New Albany Indiana
Henry Ford Health Detroit Michigan
Sahni Rheumatology and Therapy West Long Branch New Jersey
Paramount Med Rsrch and Consult LLC Middleburg Heights Ohio
University Of Pittsburgh Pittsburgh Pennsylvania
Shelby Research LLC Memphis Tennessee
Accurate Clinical Research Research Baytown Texas
Novel Research LLC Bellaire Texas
Accurate Clinical Research League City Texas
Epic Medical Research Red Oak Texas
Novartis Investigative Site San Miguel Tucumán Province
Novartis Investigative Site San Miguel de Tucumán Argentina
Novartis Investigative Site Fortaleza Ceará
Novartis Investigative Site Vitória Espírito Santo
Novartis Investigative Site Salvador Estado de Bahia
Novartis Investigative Site Salvador Estado de Bahia
Novartis Investigative Site Belo Horizonte Minas Gerais
Novartis Investigative Site Curitiba Paraná
Novartis Investigative Site Recife Pernambuco
Novartis Investigative Site Niterói Rio de Janeiro
Novartis Investigative Site Rio de Janeiro Rio de Janeiro
Novartis Investigative Site Barretos São Paulo
Novartis Investigative Site São Paulo São Paulo
Novartis Investigative Site São Paulo São Paulo
Novartis Investigative Site Salvador Brazil
Novartis Investigative Site Plovdiv Bulgaria
Novartis Investigative Site Rousse Bulgaria
Novartis Investigative Site Sofia Bulgaria

+ 95 more sites — see the full list on the official registry below.

More Novartis Pharmaceuticals trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05639114 on ClinicalTrials.gov ↗ ← All trials in the USA