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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 April 2022
• Main ID: NCT04051944
• Date of registration: 08/08/2019
• Prospective Registration: Yes
• Primary sponsor: UCB Biopharma SRL
• Public title: A Study to Assess Long-term Safety, Tolerability and Efficacy of Rozanolixizumab in Subjects With Chronic Inflammatory Demyelinating Polyradiculoneuropathy
• Scientific title: An Open-Label Extension Study to Investigate the Long-Term Safety, Tolerability, and Efficacy of Rozanolixizumab in Subjects With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
• Date of first enrolment: August 21, 2019
• Target sample size: 21
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT04051944
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

Belgium, Denmark, France, Germany, Netherlands, Spain, United Kingdom, United States

Contacts

• Name: UCB Cares
• Affiliation: 001 844 599 2273 (UCB)

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)

Intervention(s)

Drug: Rozanolixizumab

Primary Outcome(s)

Incidence of treatment-emergent adverse event (TEAEs) [Time Frame: From Baseline until Follow-Up Visit (up to Week 84)]

Secondary ID(s)

2018-004392-12

CIDP04

Source(s) of Monetary Support

Please refer to primary and secondary sponsors