A Four-Arm Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase II Study to Evaluate the Safety, Tolerability and Efficacy as Assessed by Frequent MRI Measures of 3 Doses of Atacicept Monotherapy in Subjects With Relapsing Multiple Sclerosis (RMS) Over a 36 Week Treatment Course
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- EMD Serono
- 入组人数
- 255
- 试验地点
- 1
- 主要终点
- Mean Number of Time Constant 1 (T1) Gadolinium (Gd)-Enhancing Lesions Per Participant Per Scan
研究概览
简要总结
To evaluate the safety and tolerability of atacicept and to explore if atacicept reduces central nervous system inflammation in subjects with relapsing multiple sclerosis (RMS) as assessed by frequent magnetic resonance imaging (MRI). This study is randomised. Study medication is administered via subcutaneous (under the skin) injections.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of RMS (as per McDonald criteria, 2005) Other protocol-defined inclusion criteria could apply.
排除标准
- •Have primary progressive multiple sclerosis (MS)
- •Have secondary progressive MS without superimposed relapses
- •Relevant cardiac, hepatic and renal diseases as specified in the protocol
- •Pretreatment with immunosuppressants and immunomodulating drugs as specified in the protocol
- •Clinical significant abnormalities in blood cell counts and immunoglobulin levels as specified in the protocol
- •Clinical significant acute or chronic infections as specified in the protocol Other protocol-defined exclusion criteria could apply.
研究组 & 干预措施
Atacicept 25 mg
干预措施: Atacicept (Drug)
Atacicept 75 mg
干预措施: Atacicept (Drug)
Atacicept 150 mg
干预措施: Atacicept (Drug)
Placebo
干预措施: Placebo matched to atacicept (Drug)
结局指标
主要结局
Mean Number of Time Constant 1 (T1) Gadolinium (Gd)-Enhancing Lesions Per Participant Per Scan
时间窗: Weeks 12 to 36
Analysis of T1 Gd-enhancing lesions was done using magnetic resonance imaging (MRI) scans. Only post-baseline scans were included in the calculation of this endpoint (excluding the Study Day 1 scan which had been conducted before first dosing).
次要结局
- Number of New T1 Gd-enhancing Lesions Per Participant(Weeks 12, 24, 36)
- Percentage of Participants Free From Relapses(Baseline up to Week 36)
- Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs(From the first dose of study drug administration up to 12 weeks after the last dose of the study drug)