A study to assess long-term safety, tolerability and efficacy of rozanolixizumab in subjects with chronic inflammatory demyelinating polyradiculoneuropathy

• Register: EUCTR
• Last refreshed on: 13 December 2021
• Main ID: EUCTR2018-004392-12-FR
• Date of registration: 13/05/2019
• Prospective Registration: Yes
• Primary sponsor: UCB Biopharma SPRL
• 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: 10/09/2019
• Target sample size: 34
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2018-004392-12
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no; Randomised: no; Open: yes; Single blind: no; Double blind: no; Parallel group: no; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: Placebo: Other:
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

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

Contacts

• Name: Clin Trial Reg & Results Disclosure
• Affiliation: UCB BIOSCIENCES GmbH

• Name: Clin Trial Reg & Results Disclosure
• Affiliation: UCB BIOSCIENCES GmbH

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
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

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:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP)
MedDRA version: 20.0 Level: PT Classification code 10057645 Term: Chronic inflammatory demyelinating polyradiculoneuropathy System Organ Class: 10029205 - Nervous system disorders

Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Intervention(s)

Product Name: Rozanolixizumab
Product Code: UCB7665
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: ROZANOLIXIZUMAB
Current Sponsor code: UCB7665
Other descriptive name: Rozanolixizumab
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 140-

Primary Outcome(s)

Secondary Objective: Assess long-term clinical efficacy of doses of rozanolixizumab

Main Objective: Assess long-term safety and tolerability of rozanolixizumab in subjects with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP)

Timepoint(s) of evaluation of this end point: From Baseline until Follow-Up Visit (up to Week 32)

Primary end point(s): Occurrence of treatment-emergent adverse event (TAEs)

Secondary Outcome(s)

Secondary end point(s): No secondary end points are defined.

Timepoint(s) of evaluation of this end point: No secondary end points are defined.

Secondary ID(s)

2018-004392-12-GB

CIDP04

Source(s) of Monetary Support

UCB Biopharma SPRL

Ethics review

Status: Approved
Approval date: 11/09/2019
Contact: