A Phase II, Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled, Adaptive Dose-ranging Study to Evaluate the Efficacy and Safety of AIN457 (Secukinumab) in Patients With Relapsing Multiple Sclerosis
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Cumulative Number of New Gadolinium [Gd]-Enhancing T1-weighted Lesions
研究概览
简要总结
To evaluate the efficacy and safety of AIN457 versus placebo in patients with relapsing multiple sclerosis.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Multiple Sclerosis according to 2010 revised McDonald criteria
- •Disease duration of 10 years or less
- •At least one relapse in the last year
- •EDSS score 0 to 5.0 at entry
排除标准
- •Active chronic disease of the immune system other than multiple sclerosis
- •History of malignancy within the past 5 years
- •Active systemic bacterial, viral or fungal infections
- •Previous treatment with more than one class of multiple sclerosis therapies except for previous treatment with glatiramer acetate and interferon-beta(s)
- •Any medically unstable condition
- •Unable to undergo MRI scans or repeated blood tests
- •Pregnant or nursing females
- •Women of child-bearing potential must use reliable forms of contraception
- •Other protocol-defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
AIN457 low dose
AIN457 will be administered intravenously. Approximately 65 patients will be randomized to AIN457 low dose in Stage 1. An additional 40 patients may be randomized to this group if it is one of the two selected dose groups to be expanded for Stage 2 following an Interim Analysis.
干预措施: AIN457 (Drug)
Placebo
Matching placebo will be administered intravenously. Approximately 105 patients will be randomized to placebo (65 in Stage 1 and 40 in Stage 2).
干预措施: Placebo (Drug)
AIN457 middle dose
AIN457 will be administered intravenously. Approximately 65 patients will be randomized to AIN457 middle dose in Stage 1. An additional 40 patients may be randomized to this group if it is one of the two selected dose groups to be expanded for Stage 2 following an Interim Analysis
干预措施: AIN457 (Drug)
AIN457 high dose
AIN457 will be administered intravenously. Approximately 65 patients will be randomized to AIN457 high dose in Stage 1. An additional 40 patients may be randomized to this group if it is one of the two selected dose groups to be expanded for Stage 2 following an Interim Analysis.
干预措施: AIN457 (Drug)
结局指标
主要结局
Cumulative Number of New Gadolinium [Gd]-Enhancing T1-weighted Lesions
时间窗: Months 3, 4, 5, 6
Due to early termination this trial was not powered for efficacy no statistical analysis was performed
次要结局
- Annualized Relapse Rate(6 Months)
- Combined Unique Active Lesions (CUAL)(Months 3, 4, 5, 6)
- Change in Total Volume of T2-weighted Lesions(Baseline, Month 6)
- Number of Particpants With Adverse Events as a Measure of Safety and Tolerability(6 months)