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

Last updated: December 19, 2024
Sponsor: Novartis Pharmaceuticals
Overall Status: Active - Recruiting

Phase

3

Condition

Lupus

Musculoskeletal Diseases

Cutaneous Lupus Erythematosus

Treatment

ianalumab

placebo

Clinical Study ID

NCT05624749
CVAY736F12302
2022-002690-29
2023-508499-12-00
  • Ages 12-100
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Male and female participants aged 12 years or older at the time of screening, orlimited to 18 years or older in European Economic Area countries and other countrieswhere inclusion of participants below 18 years is not allowed.

  • Diagnosis of systemic lupus erythematosus meeting the 2019 European League AgainstRheumatism/American College of Rheumatology (EULAR/ACR) SLE classification criteriaat least 6 months prior to screening.

  • Elevated serum titers at screening of anti-nuclear antibodies ≥ 1:80 as determinedby a central laboratory with a SLE-typical fluorescence pattern.

  • Currently receiving CS and/or anti-malarial treatment and/or anotherdisease-modifying antirheumatic drug (DMARD) as specified in the protocol.

  • SLEDAI-2K criteria at screening: SLEDAI-2K score ≥ 6 points, excluding pointsattributed 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

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 inclusioncriteria) administered within 12 weeks prior to screening II) cyclophosphamide orbiologics such as immunoglobulins (intravenous or s.c.), plasmapheresis, anti-type Iinterferon receptor biologic agents, anti-CD40 agents, CTLA4-Fc Ig or B-cellactivating factor (BAFF)-targeting agents administered within 24 weeks prior toscreening; belimumab administered within 12 weeks prior to screening. III) any Bcell-depleting therapies, other than ianalumab administered within 36 weeks prior torandomization or as long as B cell count is less than the lower limit of normal orbaseline 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 intramusculartreatment 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 humanimmunodeficiency 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) ifrelated 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 orequivalent using spot urine protein creatinine ratio, or serum creatinine greaterthan 2.0 mg/dL (176.84 µmol/L), or requiring immune-suppressive induction ormaintenance 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 theinvestigator will place the participant at risk for participation or interfere withevaluation for SLE-related symptoms

  • Non-lupus conditions such as asthma, gout or urticaria, requiring intermittent orchronic treatment with systemic CS

  • History of malignancy of any organ system other than localized basal cell carcinomaof the skin or in situ cervical cancer

  • Pregnant or nursing (lactating) women.

  • Women of child-bearing potential (WOCBP), defined as all women physiologicallycapable of becoming pregnant, unless they are using highly effective methods ofcontraception while on study treatment and for 6 months after stopping ofinvestigational drug.

  • Any surgical, medical, psychiatric or additional physical condition that mayjeopardize participation in this study

Study Design

Total Participants: 280
Treatment Group(s): 2
Primary Treatment: ianalumab
Phase: 3
Study Start date:
April 21, 2023
Estimated Completion Date:
January 23, 2029

Study Description

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)

Connect with a study center

  • Novartis Investigative Site

    Ciudad Autonoma de Bs As, Buenos Aires C1015ABO
    Argentina

    Active - Recruiting

  • Novartis Investigative Site

    La Plata, Buenos Aires B1900AWT
    Argentina

    Active - Recruiting

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    San Miguel, Buenos Aires 1663
    Argentina

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    San Miguel de Tucuman, Tucuman T4000CBC
    Argentina

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    Buenos Aires, C1430EGF
    Argentina

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    Tucuman, 4000
    Argentina

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    Maroochydore, Queensland 4558
    Australia

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    Victoria Park, Western Australia 6100
    Australia

    Site Not Available

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    St Leonards, 2065
    Australia

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    Valdivia, Los Rios 5110683
    Chile

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    Santiago, RM 7500588
    Chile

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    Concepcion, 6740
    Chile

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    Medellin, Antioquia 050001
    Colombia

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    Barranquilla, Atlantico 080002
    Colombia

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    Bucaramanga, Santander 0001
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    Cali, Valle Del Cauca 760046
    Colombia

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    Bogota, 111611
    Colombia

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    Cundinamarca, 111121
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    Angers Cedex 9, 49933
    France

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    Grenoble, 38043
    France

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    Montpellier Cedex 5, 34295
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    Paris, 75014
    France

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    Paris 13, 75651
    France

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    Paris Cedex 13, 75651
    France

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    Toulouse, 31400
    France

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    Toulouse 4, 31054
    France

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    Tours, 37044
    France

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    Aachen, 52074
    Germany

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    Germany

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    Erlangen, 91056
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    Koeln, 50937
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    Ahmedabad, Gujarat 380015
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    Miami, Florida 33032
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  • Integral Rheumatology and Immunology Specialists IRIS

    Plantation, Florida 33324
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  • Emory University

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    Atlanta, Georgia 30307
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    Hinsdale, Illinois 60521
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    Lexington, Kentucky 40504
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    Lake Charles, Louisiana 70601
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    Lake Charles, Louisiana 70601
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    Lake Charles, Louisiana 70601
    United States

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  • UMC New Orleans

    New Orleans, Louisiana 70112
    United States

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  • UMC New Orleans Nephrologist

    New Orleans, Louisiana 70112
    United States

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  • University Of Maryland

    Baltimore, Maryland 21201
    United States

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    Grand Blanc, Michigan 48439
    United States

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    Saint Louis, Missouri 63110
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    Philadelphia, Pennsylvania 19107
    United States

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    Philadelphia, Pennsylvania 19107
    United States

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    Jackson, Tennessee 38305
    United States

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    Jackson, Tennessee 38305
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    Bellaire, Texas 77401
    United States

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  • Novel Research LLC

    Bellaire, Texas 77401
    United States

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