NCT01144351终止1 期
A Phase 1b, Dose-Escalating, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Safety and Efficacy of Subcutaneous ELND002 in Patients With Relapsing Forms of Multiple Sclerosis
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- To determine the safety and tolerability of ELND002 including the identification of dose-limiting toxicity(ies) (DLT) and determination of the maximum tolerated dose (MTD) in patients with multiple sclerosis (MS).
研究概览
简要总结
The purpose of this study is to determine the safety and tolerability of ELND002 in patients with relapsing forms of secondary progressive multiple sclerosis (SPMS) or relapsing-remitting multiple sclerosis (RRMS).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has either clinically definite or laboratory-supported definite relapsing forms of MS for at least 2 years
- •Patients with SPMS or RRMS have documented medical history of relapse in the past year or MRI-documented evidence of MS activity in the past year
- •Has had an inadequate response or intolerability to interferon and/or glatiramer acetate
- •Is able and willing to undergo Gd administration and repeat MRI testing
排除标准
- •Has primary progressive MS (PPMS)
- •Any history of treatment with recombinant humanized monoclonal antibodies
- •Has received treatment with immunosuppressant medications or experimental agents within 3 months prior to the Baseline
- •A history of opportunistic infection or the presence of any active infection within 3 months prior to Baseline
- •Any history of congestive heart failure or currently has a pacemaker
- •Has a known or suspected hypersensitivity to sulfonamides or any of the components of the investigational drug
- •Has any medical history or psychiatric condition that would impact outcome or study participation
- •Has other clinically significant abnormality on physical, neurological, laboratory, or ECG examination as listed in the protocol during the Screening Phase
研究组 & 干预措施
ELND002
Experimental
ELND002 sc injection
干预措施: ELND002 (Drug)
Placebo
Placebo Comparator
placebo injection
干预措施: Placebo (Drug)
结局指标
主要结局
To determine the safety and tolerability of ELND002 including the identification of dose-limiting toxicity(ies) (DLT) and determination of the maximum tolerated dose (MTD) in patients with multiple sclerosis (MS).
时间窗: 12 weeks
次要结局
- Assessment of PK and PD measures of ELND002 (including but not limited to Cmax, Tmax, T1/2, AUC)(12 weeks)
- Reduction in rate of clinical relapses.(12 weeks)
- Assessment of the cumulative number and volume of Gd-enhancing T1-weighed MRI brain lesions(12 weeks)
研究者
研究点 (1)
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