EUCTR2022-002691-36-BG进行中（未招募）1 期
A randomized, double-blind, parallel group, placebo-controlled multicenter phase 3 study to evaluate efficacy, safety and tolerability of two regimens of ianalumab on top of standard-of-care therapy in patients with systemic lupus erythematosus (SIRIUS-SLE 1) - SIRIUS-SLE 1
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 406
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
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 meeting the 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,
- •British Isles Lupus Assessment Group-2004 level B disease in =2 organ systems
- •Weigh at least 35 kg at screening
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 40
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 326
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 40
排除标准
- •Prior treatment with Ianalumab
- •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 s.c.), 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/Lg), 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
- •History of major organ, hematopoietic stem cell or bone marrow transplant
- •Presence of severe lupus kidney disease as defined by proteinuria above 2g/day or equivalent using spot urine protein creatinine ratio
- •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
- •History of hypersensitivity to drugs of similar class or oral CS or to any of the constituents of the study drugs (sucrose, L-histidine hydrochloride, L-histidine, polysorbate 20)
- •History of non-compliance with medical regiments or considered potentially unreliable
- •Use of other investigational drugs within 5 half lives of enrollment or within 30 days or until the expected pharmacodynamic effect has returned to baseline, whichever is longer, or longer if required by local regulations
- •Non-lupus conditions such as asthma, gout or urticaria, requiring intermittent or chronic treatment with systemic corticosteroids
- •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, 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.
- •US (and other countries, if locally required): sexually active males unless using barrier protection during intercourse while taking study treatment
- •Any surgical, medical, psychiatric or additional physical condition that may jeopardize participation in this study
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