An Open-Label Extension Study to Investigate the Long-Term Safety, Tolerability, and Efficacy of Rozanolixizumab in Subjects With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) - CIDP04

CB Biopharma SPR0 个研究点目标入组 5 人开始时间: 待定最近更新: 2024年4月23日

适应症

试验速览

暂无简介。

•- Subject has completed one of the previous rozanolixizumab study(ies) that
•allow access to the present study (e.g. study CIDP01)
•- Female subjects of childbearing potential must agree to use a highly
•effective method of birth control, during the study and for a period of 2
•months after their final dose of investigational medicinal product (IMP)
•- Male subjects with a partner of childbearing potential must be willing to use
•a condom when sexually active during the study and for 3 months after the final
•administration of IMP

•- Subject has any medical (acute or chronic illness) or psychiatric condition
•that, in the opinion of the investigator, could harm the subject or would
•compromise the subject*s ability to participate in this study
•- Subject has a clinically relevant active infection (eg, sepsis, pneumonia,
•- Subject has a known hypersensitivity to any components of rozanolixizumab
•- Subject intends to have a live vaccination during the course of the study or
•within 7 weeks following the final dose of rozanolixizumab
•- Subject has an ongoing serious adverse event (SAE) or a medical condition in
•the parent study that the investigator considers to put the subject at a
•significantly increased risk of participating in CIDP04
•- Subject has any planned elective surgery due to occur during the study dosing
•period which in the opinion of the investigator could interfere with study

发起方

CB Biopharma SPR