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

CB Biopharma SR0 个研究点目标入组 34 人开始时间: 2019年5月23日最近更新: 2021年12月6日

适应症

试验速览

暂无简介。

•- Subject who 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 3 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
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 26
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 8

•- 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, abscess)
•- 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 procedures

发起方

CB Biopharma SR