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

Phase 1

• Conditions: Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP); MedDRA version: 20.0Level: PTClassification code 10057645Term: Chronic inflammatory demyelinating polyradiculoneuropathySystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2018-004392-12-ES
• Lead Sponsor: CB Biopharma SPR

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-06-11
• Last Update Posted: 22 June 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 34

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 2 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Assess long-term safety and tolerability of rozanolixizumab in subjects with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP);Secondary Objective: Assess long-term clinical efficacy of doses of rozanolixizumab;Primary end point(s): Occurrence of treatment-emergent adverse event (TAEs);Timepoint(s) of evaluation of this end point: From Baseline until Follow-Up Visit (up to Week 32)

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): No secondary end points are defined.;Timepoint(s) of evaluation of this end point: No secondary end points are defined.