NCT07188844终止2 期
An Open-Label Extension Study to Assess Long-term Safety and Tolerability of Batoclimab in Adult Participants With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 26
- 试验地点
- 60
- 主要终点
- Proportion of Participants with Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and TEAEs Leading to Treatment Discontinuation
研究概览
简要总结
This is an open-label extension (OLE) study designed to evaluate the long-term safety and tolerability of batoclimab in participants with CIDP who have completed Study IMVT-1401-2401 (NCT05581199). In this study, participants will receive 340 mg of batoclimab subcutaneously (SC) once weekly (QW) for up to 52 weeks. Upon completion of the Week 52 or early termination (ET) Visit, participants will transition into the 4-week Follow-up Period, which concludes with a Follow-up Visit approximately 28 (± 7) days after the Week 52 or ET Visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Any participant who has completed Study IMVT-1401-2401
- •Female participants of childbearing potential must agree to use a highly effective method of birth control
- •Female participants must agree not to donate eggs throughout the study and for 90 days after the final study treatment administration
- •Male participants must agree to use 1 highly effective contraception method with partners of childbearing potential throughout the study period and for 90 days after the final study treatment administration
- •Male participants must agree not to donate sperm throughout the study period and for 90 days after the final study treatment administration
- •Agree not to participate in another interventional study while on treatment
排除标准
- •Participant has any medical condition (acute or chronic illness) or psychiatric condition, including autoimmune disease or neurologic disease other than CIDP, or known history of drug or alcohol abuse that, in the opinion of the Investigator, could jeopardize the participant's ability to participate in this study, compromise accurate assessment of CIDP symptoms or otherwise interfere with the course and conduct of the study.
- •Participant intends to have a live vaccination during the course of the study or within 7 weeks following the final dose of batoclimab
- •Participant has an ongoing SAE or a medical condition in the IMVT-1401-2401 study that the Investigator considers putting the participant at a significantly increased risk of participating in Study IMVT-1401-2402
- •Participant has received Standard of Care therapy for treatment of a relapse in Study IMVT-1401-2401
- •Note: Other protocol specified criteria may apply.
研究组 & 干预措施
Batoclimab
Experimental
干预措施: Batoclimab (Drug)
结局指标
主要结局
Proportion of Participants with Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and TEAEs Leading to Treatment Discontinuation
时间窗: Up to 52 weeks
次要结局
- Change from Baseline in Adjusted inflammatory Neuropathy Cause and Treatment (aINCAT)(Up to 52 weeks)
- Change from Baseline in Mean Grip Strength(Up to 52 weeks)
研究者
研究点 (60)
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