NCT07286006Enrolling By Invitation2 期
A Long-Term Extension Study to Assess the Efficacy, Safety, and Tolerability of IMVT-1402 in Adult Patients With Graves' Disease
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- Enrolling By Invitation
- 入组人数
- 372
- 试验地点
- 105
- 主要终点
- Percentage of Group A Participants who remain euthyroid, Off ATD, and Off IMVT-1402
研究概览
简要总结
This is a long-term extension study that will rollover participants completing feeder studies IMVT-1402-2502 (NCT06727604) or IMVT-1402-2503 (NCT07018323) to evaluate the efficacy and safety of IMVT-1402 in adult participants with GD. Eligible participants will be assigned to 1 of 3 study groups (Groups A, B and C) based on their GD status at the completion of their respective feeder study.
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
- •Participants who completed Study IMVT-1402-2502 or Study IMVT-1402-
- •Other, more specific inclusion criteria are defined in the protocol.
排除标准
- •Have permanently discontinued IMP during the treatment period in the feeder study or have met study stopping criteria at any point up until the end of participation in the feeder study.
研究组 & 干预措施
Group A
Experimental
干预措施: IMVT-1402 (Drug)
Group C
No Intervention
Group B
No Intervention
结局指标
主要结局
Percentage of Group A Participants who remain euthyroid, Off ATD, and Off IMVT-1402
时间窗: At Week 52
次要结局
- Percentage of Group A Participants who are euthyroid and off ATD(At Week 26)
- Percentage of Group B Participants who remain euthyroid, off ATD, and off IMVT-1402(Up to Week 52)
- Percentage of Group C Participants who remain euthyroid, off ATD, and off IMVT-1402(Up to Week 52)
- Percentage of Group A Participants who are euthyroid, off ATD, and seronegative for TRAb(At Week 26)
- Percentage of Group A Participants who are euthyroid and off ATD(Up to Week 52)
- Percentage of Group A Participants who are euthyroid, off ATD, and off IMVT-1402(Up to Week 52)
- Time to earliest date of euthyroidism, off ATD, and off IMVT-1402 to the earliest date of confirmed relapse in Group A Participants(Up to Week 52)
- Percentage of Group B Participants who remain euthyroid, off ATD, and off IMVT-1402(At Week 52)
- Time from Week 0 to the earliest date of confirmed relapse in Group B Participants(Up to Week 52)
- Percentage of Group C Participants who remain euthyroid, off ATD, and off IMVT-1402(At Week 52)
- Time From Week 0 to the earliest date of confirmed relapse in Group C Participants(Up to Week 52)
- Percentage of Group A Participants who are euthyroid, off ATD, and seronegative for TRAb(Up to Week 52)
研究者
研究点 (105)
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