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
干预措施
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
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Biological)
BYM338
Experimental
干预措施: BYM338 (Biological)
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)
Loading locations...
相似试验
已完成
2 期
BYM338 in Chronic Obstructive Pulmonary Disease (COPD) Patients With CachexiaChronic Obstructive Pulmonary Disease (COPD) With CachexiaNCT01669174Novartis Pharmaceuticals67
已完成
2 期
Clinical Study of BYM338 for the Treatment of Unintentional Weight Loss in Patients With Cancer of the Lung or the PancreasCachexiaNCT01433263Novartis Pharmaceuticals57
已完成
1 期
Evaluation of Safety and Pharmacokinetics of Single Doses of VBY-376 in Healthy AdultsChronic Hepatitis C InfectionNCT00557583Virobay Inc.48
已完成
2 期
A Study of LY3041658 in Adults With Hidradenitis SuppurativaHidradenitis SuppurativaNCT04493502Eli Lilly and Company72
Unknown
3 期
Patients With Type 2 Diabetes Mellitus With Insufficient Glycaemic Control Despite Treatment With Metformin Alone or Metformin in Combination With a SulfonylureaType 2 DiabetesNCT01257334Taipei Medical University WanFang Hospital1,390