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)
Condition(s) studied
Systemic Lupus Erythematosus
Investigational drug(s) / intervention(s)
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
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.
More Novartis Pharmaceuticals trials in Spain
Other trials for the same condition