NCT00774943已完成1 期
A Randomized, Double-blind, Placebo-controlled, Ascending, Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 557 in Subjects With Systemic Lupus Erythematosus
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Subject incidence of treatment-emergent adverse events and the incidence of antibodies to AMG 557.
研究概览
简要总结
This is a Phase 1, randomized, placebo-controlled, double-blind, dose-escalation study of repeat SC doses of AMG 557 in adults with Systemic Lupus Erythematosus.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Before any study-specific procedure, the appropriate written informed consent must be obtained;
- •Men and women, between the ages of 18 and 70 years old, inclusive, at the time of randomization;
- •Diagnosis of SLE as defined by the most recent ACR criteria, including a positive ANA at screening or documented positive ANA (the titer should be at least 1:80) in the past.
- •SLE duration of at least six months, as diagnosed by a physician;
- •Stable disease, defined as no change in SLE therapy within the previous 30 days; and, in the opinion of the investigator, no anticipated need for a change in SLE therapy will be required while the subject is enrolled in the study;
- •Normal or clinically acceptable ECG (12-lead reporting ventricular rate and PR, QRS, QT, QTc) at screening and Day -1 based on the opinion of the investigator;
- •Body mass index from 18 to 40 kg/m2 at screening;
- •Able and willing to complete entire study according to study schedule.
- •Immunizations up to date, with a minimum of tetanus, diphtheria, pertussis (td/Tdap), pneumococcal (polysaccharide) and influenza (during flu season) vaccinations, as determined by the Principal Investigator.
排除标准
- •Positive serology for HIV antibodies, hepatitis B surface antigen or hepatitis C antibodies (confirmed by PCR or RIBA);
- •Have had signs or symptoms of a viral, bacterial or fungal infection within 30 days of study randomization;
- •Evidence of active or latent tuberculosis as assessed by PPD or Quantiferon testing at screening;
- •Have donated blood or experienced a loss of blood >500mL within 4 weeks of randomization;
- •History of ethanol or drug abuse within the last one year prior to randomization;
- •Evidence of significant renal insufficiency, defined by:
- •The glomerular fitration rate < 50 mL/min using the Cockroft and Gault equation;
- •Evidence of liver disease (eg, serum ALT or AST > 2x upper limit of normal);
- •Total WBC <3000 x 106/L;
- •Neutrophil count < 1500 x106/L
- •Platelet count <75,000 x 106/L
- •Hemoglobin <10g/dL
- •Any disorder (including psychiatric), condition or clinically significant disease (other than a diagnosis of SLE) that would, by it progressive nature and/or severity, interfere with the study evaluation, completion and/or procedures in the medical judgment of the investigator. This includes any age related co-morbidites such as presence of congestive heart failure, angina, chronic obstructive pulmonary disease, asthma, and malignancies (other than resected squamous and basal cell carcinoma of the skin).
- •Presence or history of vasculitis (comprising internal organs or extremities or leading to peripheral neuropathy) within the last 3 years, presence or history of active CNS lupus (defined as seizure disorder, cerebral vascular accident, psychosis ascribed to SLE , encephalitis, meningitis, and myelitis) requiring therapy within the last 3 years;
- •Uncontrolled hypertension (Blood pressure > 150/95);
- •Poorly controlled diabetes (HbA1c > 8%);
- •Any history of granulomatous disease including autoimmune granulomatous vasculitis and sarcoidosis;
- •Underlying condition that predisposes the subject to infections (eg, history of splenectomy);
- •Any disorder or condition that prevents the subject from providing truly informed consent;
- •Prior administration of any other biologic that primarily targets the immune system (eg, Lymphostat-B, TACI-Ig, or CTLA4-Ig) in the past 9 months. This includes prior administration of AMG 557;
- •Presence of AMG 557 anti-bodies;
- •Prior administration of rituximab > 9 months with CD19+ B cells <5/µL;
- •Administration of cyclophosphamide (or any other alkylating agent), cyclosporine, tacrolimus, or sirolimus, or > 100 mg/day prednisone or equivalent in the 6 months prior to randomization;
- •Participated in an investigational drug trial involving a monoclonal antibody (not targeting the immune system) within 3 months or 5 half-lives, whichever time period is longer, prior to randomization;
- •Participated in any another investigational drug or device trial within the previous 30 days or 5 half-lives, whichever time period is longer, prior to randomization;
- •Administration of >10 mg/day prednisone (or equivalent) in the 30 days prior to randomization;
- •Known sensitivity to mammalian derived products;
- •Unwilling to practice an effective method of double-barrier contraception as determined by the investigator for the duration of the study;
- •Positive serum hCG at screening or positive urine hCG on D-1; or females who are currently lactating;
- •Known allergies to shellfish or any excipients found in KLH;
- •Previous immunization with KLH.
研究组 & 干预措施
AMG 557
Active Comparator
干预措施: AMG 557 (Drug)
Placebo
Placebo Comparator
干预措施: AMG 557 (Drug)
结局指标
主要结局
Subject incidence of treatment-emergent adverse events and the incidence of antibodies to AMG 557.
时间窗: Throughout study period
次要结局
- Serum PK profile of AMG 557 after multiple dose administrations. Biomarkers of pharmacodynamic activity for AMG 557.(Throughout study period)
研究者
研究点 (1)
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