A Study to Assess Long-term Safety, Tolerability and Efficacy of Rozanolixizumab in Subjects With Chronic Inflammatory Demyelinating Polyradiculoneuropathy

UCB

Status and phase

Completed

Phase 2

Conditions

Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)

Treatments

Drug: Rozanolixizumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT04051944

CIDP04

2018-004392-12 (EudraCT Number)

Details and patient eligibility

About

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).

Enrollment

21 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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