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
- 终止
- 入组人数
- 109
- 试验地点
- 107
- 主要终点
- Duration of proptosis response off treatment in study eye in batoclimab responder participants in the feeder studies
研究概览
简要总结
This is a 2-cohort (observational and treatment cohort) extension study for participants completing feeder studies (IMVT-1401-3201 or IMVT-1401-3202). The observational cohort will assess the durability of proptosis response of feeder studies off treatment. The treatment cohort will evaluate the efficacy of batoclimab as assessed by proptosis responder rate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •For all participants:
- •1. 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 batoclimab
- •Additional inclusion criteria are defined in the protocol.
排除标准
- •For all participants:
- •1. In the Investigator's judgement, the benefits of entry in the study do not outweigh the risk.
研究组 & 干预措施
Treatment Cohort
Proptosis non-responders in feeder studies will be administered batoclimab of 680 milligram (mg) subcutaneous (SC) for 12 weeks followed by 340 mg SC for 12 weeks
干预措施: Batoclimab (Drug)
Observational cohort
Proptosis responders in feeder studies will enter in a non-treatment observational study
干预措施: Observational cohort study (Other)
结局指标
主要结局
Duration of proptosis response off treatment in study eye in batoclimab responder participants in the feeder studies
时间窗: Up to Week 24
次要结局
- Percentage of proptosis responders in study eye in placebo non-responder participants in the feeder studies(At Week 24)
- Percentage of proptosis responders in study eye in batoclimab non-responder participants in the feeder studies(At Week 24)