NCT01423110已完成2 期
A Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of BYM338 in Patients With Sporadic Inclusion Body Myositis
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 3
- 主要终点
- Effect of BYM338 on Thigh Muscle Volume by MRI
研究概览
简要总结
This study will assess the efficacy, safety and tolerability of BYM338 in patients with sporadic Inclusion Body Myositis
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
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and Females aged 40-80 with a confirmed diagnosis of sporadic Inclusion Body Myositis
排除标准
- •Unable to walk at least 3 meters without assistance from another person
- •Use of oral beta agonists, oral corticosteroids, androgens or androgen inhibitors, or intravenous gamma globulin in the last 6 months
- •patients with a history or presence of renal impairment and/or liver disease
- •Other protocol-defined inclusion/exclusion criteria may apply
结局指标
主要结局
Effect of BYM338 on Thigh Muscle Volume by MRI
时间窗: 8 weeks
Change in thigh muscle volume
次要结局
- Effect of BYM338 on muscle function by 'Timed Get Up and Go' test(8 weeks)
研究者
研究点 (3)
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