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)
Proportion of participants on monthly ianalumab achieving Systemic Lupus Erythematosus Responder Index -4 (SRI-4) — Week 60 SRI-4 response is defined as:
* Systemic Lupus Erythematosus Disease Activity Index - 2000 (SLEDAI-2K) reduction from baseline of ≥ 4 points
* No British Isles Lupus Assessment Group-2004 (BILAG-2004) worsening, defined as ≥ 1 new A or ≥ 2 new B items compared to baseline
* No worsening in Physician Global Assessment of Disease Activity (PhGA), defined as an increase of ≥ 0.3 from baseline on a 0 to 3 visual analog scale
Trial sites (135)
Facility
City
Region
Status
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.
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.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.