EUCTR2018-001508-12-FR进行中（未招募）1 期
A placebo-controlled, patient and investigator blinded, randomized parallel cohort study to assess pharmacodynamics, pharmacokinetics, safety, tolerability and preliminary clinical efficacy of VAY736 and CFZ533 in patients with systemic lupus erythematosus (SLE)
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •- Written informed consent must be obtained before any assessment is performed
- •- Male and female patients 18 to 75 years of age
- •- Fulfill =4 of the 11 American College of Rheumatology 1997 classification criteria for SLE
- •- Patient diagnosed with SLE for at least 6 months prior to screening
- •- Elevated serum titers at screening of ANA (=1:80) of a pattern consistent with an SLE diagnosis, including either anti-double stranded DNA (anti-ds DNA), anti-Ro (SSA), anti-La (SSB), anti-nuclear ribonucleoprotein (anti-RNP) or anti-Smith (anti-Sm)
- •- Currently receiving corticosteroids and/or antimalarials and/or another DMARD on a stable dose according to protocol requirements
- •- SLEDAI-2K score of =6 at screening
- •- BILAG 2004 score of =1A or =2B in mucocutaneous domain at screening
- •- Weigh at least 40 kg at screening
- •- Other protocol-defined inclusion criteria may apply
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 100
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •Cohort 2 (CFZ533/Placebo) only:
- •- Patients who are at significant risk for thromboembolic events based on the following:
- •-- History of either thrombosis or 3 or more spontaneous abortions
- •-- Presence of lupus anticoagulant or significantly prolonged partial thromboplastin time (PTT) consistent with co-existent anti-phospholipid syndrome and without concurrent prophylactic treatment with aspirin or anticoagulants as per local standard of care
- •All Cohorts:
- •- History of receiving prior to screening:
- •-- Within 12 weeks: i.v. corticosteroids, calcineurin inhibitors or mycophenolate mofetil
- •-- Within 24 weeks: cyclophosphamide, intravenous Ig, plasmapheresis, anti-TNF-a mAb, CTLA4-Fc Ig (abatacept) or BAFF targeting agents (e.g., belimumab)
- •-- Any B-cell depleting therapies (administered >1 year ago) and with a Bcell count <50 cells/µL at time of screening; or, any B-cell depleting therapies within 52 weeks prior to screening
- •- Evidence of active tuberculosis as assessed by Quantiferon testing at screening
- •- Presence of human immunodeficiency virus (HIV) infection at screening
- •- Severe organ dysfunction or life threatening disease; ECOG performance status > 1 at screening
- •- History of WHO Class III-IV renal involvement with proliferative disease or nephrotic range proteinuria (above 2 g/day) requiring immune suppressive induction or maintenance treatment exceeding
- •protocol-defined limits
- •- Active viral, bacterial or other infections at the time of screening or enrollment
- •- Receipt of live/attenuated vaccine within a 2month period before first dosing
- •- Uncontrolled, co-existing serious disease, e.g., uncontrolled hypertension, heart failure, type I diabetes, thyroid disease within 3 months prior to first dosing, or significant, unresolved illness within 2
- •weeks prior to first dosing
- •- History of hypersensitivity to drugs of similar chemical class
- •- Other protocol-defined exclusion criteria may apply
研究者
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