2024-514133-38-00招募中3 期
A Randomized, Double-Blinded, Placebo-Controlled, Phase 3, Parallel-Group Design Study Evaluating the Efficacy and Safety of Efgartigimod PH20 SC Administered by Prefilled Syringe in Adult Participants With Ocular Myasthenia Gravis
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- Argenx
- 入组人数
- 163
- 试验地点
- 38
- 主要终点
- MGII (PRO) ocular score change from baseline to day 29 in part A
研究概览
简要总结
To determine the efficacy of efgartigimod PH20 SC compared to placebo PH20 SC (placebo) in participants with oMG in part A
研究设计
- 分配方式
- Not Applicable
- 主要目的
- Part B
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Is at least 18 years of age and the local legal age of consent for clinical studies
- •Has been diagnosed with myasthenia gravis and supported by seropositivity for AChR-Ab; or abnormal neuromuscular transmission demonstrated by abnormal neurophysiology testing and history on positive edrophonium chloride testing or demonstrated improvement on MG therapy
- •Is MGFA Class I (any ocular muscle weakness)
- •Has a screening and baseline MGII (PRO) ocular score of at least 6 with at least 2 ocular items with a score of at least 2
排除标准
- •Other diseases that lead to eyelid drooping, peripheral muscle weakness, or diplopia
- •Known autoimmune disease or any medical condition other than indication under study that would interfere with an accurate assessment of clinical symptoms of ocular myasthenia gravis or puts the participant at undue risk
结局指标
主要结局
MGII (PRO) ocular score change from baseline to day 29 in part A
MGII (PRO) ocular score change from baseline to day 29 in part A
次要结局
- • MG-ADL ocular domain score change from baseline to day 29 in part A
- • MGII total score change from baseline to day 29 in part A
- • MGII (PE) ocular score change from baseline to day 29 in part A
- • MG-ADL total score change from baseline to day 29 in part A
- • MGII (PRO+PE) ocular score change from baseline to day 29 in part A
- • MGII ocular scores (PRO, PRO+PE, and PE), generalized score, and total score; actual values and changes from baseline in part A and part A+B
- • Incidence and severity of AEs and SAEs in part A and part A+B
- • Clinically relevant changes in laboratory parameters, vital signs, and ECGs in part A and part A+B
- • MG-QoL15r total score actual values and changes from baseline in part A and part A+B
- • NEI VFQ-25 score actual values and changes from baseline in part A and part A+B
- • Actual values and percent changes from baseline in total IgG levels over time in part A and part A+B
- Actual values and percent change from baseline in AChR-Ab levels in AChR-Ab seropositive participants over time in part A and part A+B
- • Incidence and prevalence of Anti-Drug Antibodies and Neutralizing Antibodies against efgartigimod in part A and part A+B
- • Incidence and prevalence of antibodies and Neutralizing Antibodies against rHuPH20 in part A and part A+B
研究者
Chief Scientific Officer
Scientific
Argenx
研究点 (38)
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