2024-512650-21-00招募中3 期
An Open-label Extension Study for Participants who Completed Study IMVT-1401-3201 or Study IMVT-1401-3202 to Assess the Efficacy and Safety of Batoclimab for the Treatment of Thyroid Eye Disease (TED)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 73
- 试验地点
- 38
- 主要终点
- Duration of proptosis response off treatment in study eye in participants who were batoclimab responders in the feeder studies.
研究概览
简要总结
To describe batoclimab maintenance of efficacy as assessed by proptosis.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •For all participants: have completed the Week 24 visit of the feeder study.
- •For participants assigned to the Open-label Treatment Cohort:
- •Do not require immediate surgical intervention and is not planning corrective surgery/irradiation or medical therapy for TED during the course of the study.
- •Did not permanently discontinue study drug.
排除标准
- •For all participants: in the Investigator's judgement, the benefits of entry in the study do not outweigh the risk.
结局指标
主要结局
Duration of proptosis response off treatment in study eye in participants who were batoclimab responders in the feeder studies.
Duration of proptosis response off treatment in study eye in participants who were batoclimab responders in the feeder studies.
次要结局
- Proportion of proptosis responders at Week 24 in study eye in participants who were placebo non-responders in the feeder studies.
- Proportion of proptosis responders at Week 24 in study eye in participants who were batoclimab non-responders in the feeder studies.
研究者
Immunovant Clinical Trials
Scientific
Immunovant Sciences GmbH
研究点 (38)
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