EUCTR2018-001508-12-ES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)
ovartis Farmacéutica, S.A.0 个研究点目标入组 120 人开始时间: 2018年10月9日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 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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