jRCT2080222316未知3 期
A randomized, double-blind, placebo-controlled, multicenter, parallel group, dose-finding, pivotal, phase IIb/III study to evaluate the efficacy, safety and tolerability of intravenous BYM338 at 52 weeks on physical function, muscle strength, and mobility and additional long-term safety up to 2 years in patients with sporadic inclusion body myositis
适应症
试验速览
- 阶段
- 3 期
- 入组人数
- 240
- 主要终点
- Change from Baseline in 6 Minute Walking Distance Test (6MWD) meters to Week 52
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 干预模型
- A Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel Group
入排标准
- 年龄范围
- 36age old over 至 85age old under（—）
- 性别
- All
入选标准
- •Diagnosed with sporadic inclusion body myositis; Must be able to walk (assistive aids allowed, including intermittent use of wheelchair)
排除标准
- •Must not be using corticosteroids. Must not have used systemic corticosteroid (at daily dose >=10mg prednisone) for the past 3 months; Must not be pregnant or nursing; Must not have a chronic active infection (e.g., HIV, hepatitis B or C, tuberculosis, etc); Other protocol-defined inclusion/exclusion criteria may apply
- •Any non-sIBM conditions or other neurologic, neuromuscular diseases that significantly limit mobility (polymyositis, dermatomyositis, polymyalgia rheumatica, fibromyalgia, significant dementia/Alzheimer's disease, Parkinson's disease, amyotrophic lateral sclerosis, stroke, cerebral palsy, epilepsy, multiple sclerosis, spinal cord injury, muscular dystrophy, myasthenia gravis, ).
- •Significant cardiovascular diseases.
- •Ongoing immunosuppressive therapy (antibody therapy within past 6 months or non-antibody therapy within past 3months prior to randomization).
结局指标
主要结局
Change from Baseline in 6 Minute Walking Distance Test (6MWD) meters to Week 52
时间窗: Baseline, Week 52
Change from baseline to Week 52 in the distance a patient can walk in a set timeframe. 6 Minute Walking Distance Test measures the distance (in meters) that a patient can walk in a 6 minute timeframe.
次要结局
- Change from Baseline in lean body mass (LBM) at Week 52(Baseline, Week 52)
- Change from Baseline in quadriceps Quantitative Muscle Testing (QMT) at Week 52(Baseline, Week 52)
- Change from Baseline in Patient-Reported Physical Function at Week 52(Baseline, Week 52)
- Rate of Fall Events(Baseline, Day 1, Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, 104, 108)
- Change from Baseline in Short Physical Performance Battery score at Week 52(Baseline, Week 52)
- Safety and Tolerability of different i.v. BYM338 doses(Baseline, Day 1, Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, 104, 108)
- Change from Baseline in 6MWD meters to Week 52(Baseline, Week 52)
研究者
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