2024-518364-12-00招募中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)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 35
- 试验地点
- 21
- 主要终点
- Proportion of participants with TEAEs, SAEs, and TEAEs leading to study treatment discontinuation.
研究概览
简要总结
To evaluate the long-term safety and tolerability of batoclimab in participants with CIDP
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
- 否
入选标准
- •Any participant who has completed Study IMVT-1401-2401; in the event that Study IMVT-1401-2401 is prematurely terminated for reasons that do not affect the benefit:risk profile, any participant that may benefit from continued access to batoclimab in the opinion of the Investigator.
- •Female participants of childbearing potential must agree to use a highly effective method of birth control from the signing of informed consent until 90 days after the last dose of study treatment.
- •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.
- •Are willing and capable of giving written informed consent, which includes being able to comply with all aspects of the study treatment and testing schedule. For participants who wish to avail themselves of the option for at-home study treatment administration, this includes the ability to receive or self-administer study treatment at home or outside of the study site clinic.
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 subject at a significantly increased risk of participating in Study IMVT-1401-
- •Participant has received Standard of Care therapy for treatment of a relapse in Study IMVT-1401-2401.
结局指标
主要结局
Proportion of participants with TEAEs, SAEs, and TEAEs leading to study treatment discontinuation.
Proportion of participants with TEAEs, SAEs, and TEAEs leading to study treatment discontinuation.
次要结局
- Change from baseline over time in the following scores: • Adjusted INCAT • Mean Grip Strength
研究者
Immunovant Clinical Trials
Scientific
Immunovant Sciences GmbH
研究点 (21)
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