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CIDP04

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

Brief summary

The purpose of the study is to assess long-term safety and tolerability of weekly doses of rozanolixizumab in subjects with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP).

Medical Condition

Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP)

Min. Age

18
Years

Max. Age

-

Who Can Join?

All

Status

Enrolling by invitation
Inclusion criteria
- 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
Exclusion criteria
- 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

Study Medication Description

Study Medication:

rozanolixizumab

Other Descriptive Name:

UCB7665

Placebo

No

Comparator:

No

Study Dates

August 2019

Actual Start Date of Enrollment

February 2022

Planned Study Completion Date

General Information

Study ID:
CIDP04
EudraCT Number:
2018-004392-12
CT.gov Number:
NCT04051944
Phase:
Phase 2

Interested in enrolling in our study?

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