An open-label Extension study to evaluate rozanolixizumab in pediatric study participants with generalized myasthenia gravis
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 7
- 试验地点
- 5
- 主要终点
- - Occurrence of serious Treatment-Emergent Adverse Events (TEAEs) up to the End of Study (EOS) Visit - Occurrence of TEAEs leading to permanent withdrawal of IMP up to the EOS Visit - Occurrence of Adverse Event(s) of Special Monitoring (AESM) up to the EOS Visit
研究概览
简要总结
Assess the long term safety and tolerability of additional 6-week treatment cycles with rozanolixizumab in pediatric participants with generalized Myasthenia Gravis (gMG) aged ≥2 at the time of the Screening Visit of MG0006
入排标准
- 年龄范围
- 0 years 至 64 years（0-17 Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Study participant must meet one of the following: - −Study participant completed MG0006 according to the protocol - −Study participant completed the MG0006 Treatment Period and has a worsening of gMG symptoms in the Observation Period of MG0006
排除标准
- •Study participant met any mandatory withdrawal or mandatory permanent IMP discontinuation criteria in MG0006 or permanently discontinued IMP - Study participant has a known hypersensitivity to any components of the IMP or other FcRn drugs - Study participant has any laboratory abnormality that, in the opinion of the Investigator, is clinically significant, has not resolved at Baseline, and could jeopardize or compromise the study participant’s ability to participate in this study
研究组 & 干预措施
-
Participants receiving -
干预措施: - (Drug)
结局指标
主要结局
- Occurrence of serious Treatment-Emergent Adverse Events (TEAEs) up to the End of Study (EOS) Visit - Occurrence of TEAEs leading to permanent withdrawal of IMP up to the EOS Visit - Occurrence of Adverse Event(s) of Special Monitoring (AESM) up to the EOS Visit
- Occurrence of serious Treatment-Emergent Adverse Events (TEAEs) up to the End of Study (EOS) Visit - Occurrence of TEAEs leading to permanent withdrawal of IMP up to the EOS Visit - Occurrence of Adverse Event(s) of Special Monitoring (AESM) up to the EOS Visit
次要结局
- - Percent change in total Immunoglobulin G (IgG) from Baseline to the end of Week 6 of each Treatment Period (TP) - Absolute change in total IgG from Baseline to the end of Week 6 of each TP - Change from Baseline in Myasthenia Gravis-Activities of Daily Living (MG ADL) total score at the end of Week 6 of each TP - Change from Baseline in Quantitative Myasthenia Gravis (QMG) total score at the end of Week 6 of each TP
研究者
UCB Cares
Scientific
UCB Biopharma