2023-508499-12-00招募中3 期
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)
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 67
- 试验地点
- 32
- 主要终点
- Proportion of participants achieving SRI-4 at Week 60
研究概览
简要总结
To demonstrate superiority of xxx ianalumab XXX mg xxx XXX, compared to placebo, in achieving Systemic Lupus Erythematosus Responder Index (SRI-4) at Week 60
入排标准
- 年龄范围
- 0 years 至 65+ years（18-64 Years, 65+ Years, 0-17 Years）
- 接受健康志愿者
- 是
入选标准
- •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 (SLE) meeting the EULAR/ACR SLE classification criteria at least 6 months prior to screening
- •Elevated serum titers at screening of Antinuclear Antibodies (≥1:80) as determined by a central laboratory with a SLE typical fluorescence pattern.
- •Currently receiving corticosteroids 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" British Isles Lupus Assessment Group-2004 disease activity level at screening of at least 1 of the following: British Isles Lupus Assessment Group-2004 level A disease in ≥1 organ system, Or British Isles Lupus Assessment Group-2004 level B disease in ≥2 organ systems
- •Weigh at least 35 kg at screening
排除标准
- •Prior treatment with Ianalumab
- •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.
- •History of receiving following treatment I) high dose corticosteroids, calcineurin inhibitors, JAK or other kinase inhibitors or other DMARD (except as listed in inclusion criteria) 12 weeks prior to screening II) Cyclophosphamide or biologics such as immunoglobulins (i.v. or XXX), plasmapheresis, anti-type I interferon receptor biologic agents, anti- CD40 agents, CTLA4-Fc Ig or B-cell activating factor-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 (HBV) or hepatitis C (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 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 anemia 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 2g/day or equivalent using spot urine protein creatinine ratio
- •Any surgical, medical, psychiatric or additional physical condition that may jeopardize participation in this study
研究组 & 干预措施
-
Auxiliary
Participants receiving -
干预措施: - (Drug)
结局指标
主要结局
Proportion of participants achieving SRI-4 at Week 60
Proportion of participants achieving SRI-4 at Week 60
次要结局
- Proportion of participants with no moderate or severe British Isles Lupus Assessment Group flare up to Week 60
- Proportion of participants maintaining between Week 36 and Week 60 a reduced corticosteroid dose of predniso(lo)ne ≤5 mg/day or ≤baseline dose, whichever is lower
- Proportion of participants achieving British Isles Lupus Assessment Group-based Composite Lupus Assessment at Week 60
- Proportion of participants achieving Lupus Low Disease Activity State at Week 60
- Time to first occurrence of SRI-4 from baseline to Week 60
- Proportion of participants achieving SRI-4 at Week 60 while maintaining between Week 36 and Week 60 a reduced corticosteroid dose of predniso(lo)ne ≤5 mg/day or ≤baseline dose, whichever is lower
- Proportion of participants achieving SRI-6 at Week 60
- Proportion of participants achieving SF-36 Bodily Pain response at Week 60
- Proportion of participants with AEs and SAEs
- Clinical laboratory measurements
- Vital Signs
- Incidence and titer of anti-ianalumab antibodies in serum (ADA assay) over time
- Ianalumab concentration in serum during the treatment and followup (up to the end of study)
研究者
Novartis Pharma Arzneimittel GmbH
Scientific
Novartis Pharma AG
研究点 (32)
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