jRCT2021200038进行中（未招募）不适用
An Open-Label Extension Study to Evaluate Rozanolixizumab in Study Participants With Generalized Myasthenia Gravis (MG0007)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 18
- 主要终点
- Percentage of participants with treatment-emergent adverse events (TEAEs)
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
- Open(masking Not Used)
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •Study participant must meet one of the following:
- •a) completed MG0003 [NCT03971422]
- •b) required rescue therapy during the Observation Period in MG0003
- •c) completed at least 6 visits in MG0004 [NCT04124965]
- •Body weight >=35 kg at Baseline (Day 1)
- •Study participants may be male or female
排除标准
- •Study participant has a known hypersensitivity to any components of the study medication or other anti-neonatal Fc receptor (FcRn) medications
- •Study participant with a known tuberculosis (TB) infection, at high risk of acquiring TB infection, or latent tuberculosis infection (LTBI), or current/history of nontuberculous mycobacterial infection (NTMBI)
- •Study participant met any mandatory withdrawal or mandatory study drug discontinuation criteria in MG0003 or MG0004, or permanently discontinued study drug in either study
- •Study participant intends to have a live vaccination during the course of the study or within 8 weeks following the final dose of rozanolixizumab
- •Study participant with severe (defined as Grade 3 on the Myasthenia Gravis-Activities of Daily Living (MG-ADL) scale) weakness affecting oropharyngeal or respiratory muscles, or who has myasthenic crisis or impending crisis
结局指标
主要结局
Percentage of participants with treatment-emergent adverse events (TEAEs)
Percentage of participants with treatment-emergent adverse events (TEAEs)
Percentage of participants with (TEAEs) leading to permanent withdrawal of investigational medicinal product (IMP)
Percentage of participants with (TEAEs) leading to permanent withdrawal of investigational medicinal product (IMP)
次要结局
未报告次要终点
研究者
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