jRCT2021210003进行中（未招募）不适用
A Randomized, Double-Blind, Multicenter, Placebo-Controlled Phase 3 Study with Open-Label Period to Evaluate the Efficacy and Safety of Inebilizumab in Adults with Myasthenia Gravis (VIB0551.P3.S1)
Amgen Inc.0 个研究点目标入组 16 人开始时间: 2021年8月18日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 16
- 主要终点
- Change from baseline in Myasthenia Gravis Activities of Daily Living (MG-ADL) score
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Double Blind
入排标准
- 年龄范围
- 18age 0month 0week old over 至 No limit（—）
- 性别
- All
入选标准
- •Diagnosis of MG with anti-AChR or anti-MuSK antibody.
- •MGFA Clinical Classification Class II, III, or IV.
- •MG-ADL score of 6 or greater at screening and at randomization with > 50% of this score attributed to non-ocular items.
- •QMG score of 11 or greater.
- •Participants must be on:
- •a. Corticosteroids only, with no dose increase within 4 weeks prior to randomization, or
- •b. One allowed non-steroidal immunosuppressive therapy (IST), with continuous use for at least 6 months prior to randomization and no dose increase within 4 months prior to randomization, or
- •c. Combination of (1) corticosteroids with no dose increase within 4 weeks prior to randomization and (2) one allowed non-steroidal IST with continuous use for at least 6 months prior to randomization and no dose increase within 4 months prior to randomization.
- •Allowed ISTs, alone or in combination with corticosteroids, are azathioprine, mycophenolate mofetil, and mycophenolic acid.
- •Tacrolimus is allowed in Japan only, at a dose of <= 3 mg/day, with continued use for at least 6 months prior
- •to randomization and no dose increase within 4 months prior to randomization.
排除标准
- •Receipt of the following medications within the 4 weeks prior to Day 1:
- •a. Cyclosporine (except eye drops)
- •b. Tacrolimus (except topical) (tacrolimus <= 3 mg/day is allowed in Japan only)
- •c. Methotrexate
- •Current use of:
- •a. Corticosteroids (prednisone > 40 mg/day or > 80 mg over a 2-day period [or equivalent dose of other corticosteroids])
- •b. Acetylcholinesterase inhibitors (pyridostigmine) > 480 mg/day or unstable dose in the 2 weeks prior to Day
- •c. Azathioprine > 3 mg/kg/day
- •d. Mycophenolate mofetil > 3 g/day or mycophenolic acid > 1440 mg/day
- •e. Any IST, alone or in combination with corticosteroids, except for azathioprine, mycophenolate mofetil, and mycophenolic acid.
结局指标
主要结局
Change from baseline in Myasthenia Gravis Activities of Daily Living (MG-ADL) score
时间窗: Week 26
Change from baseline in Myasthenia Gravis Activities of Daily Living (MG-ADL) score at Week 26 in the overall study population (ie, the AChR-Ab+ and MuSK-Ab+ populations)
次要结局
- Change from baseline in Quantitative Myasthenia Gravis (QMG) score at Week 26(Week 26)
- Change from baseline in MG-ADL score at Week 26(Week 26)
- Change from baseline in QMG score at Week 26(Week 26)
- Change from baseline in Myasthenia Gravis Composite (MGC) score at Week 26(Week 26, Week 52)
- Proportion of subjects with >= 3-point improvement in MG-ADL score at Week 26 and no use of rescue therapy(Week 26, Week 52)
- Change from baseline in MG-ADL score at Week 52(Week 52)
- Change from baseline in QMG score at Week 52(Week 52)
- Change from baseline in Myasthenia Gravis Quality of Life-15 revised (MGQOL-15r) score at Week 26(Week 26, Week 52)
- Patient Global Impression of Change score at Week 26(Week 26, Week 52)
- Time to first MG exacerbation by Week 26(Week 26, Week 52)
- Safety and tolerability of inebilizumab
- Proportion of subjects with steroid tapered to <= 5 mg/day at Week 26(Week 26, Week 52)
- Proportion of subjects in whom steroid dose was reduced by >= 50% by Week 26(Week 26, Week 52)
- Proportion of subjects achieving minimal symptom expression(Week 26)
- Anti-drug antibody status and titer during the study
研究者
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