Clinical trial NCT04051944: A Study to Assess Long-term Safety, Tolerability and Efficacy of Rozanolixizumab in Subjects With Chronic Inflammatory Demyelinating Polyradiculoneuropathy
Official 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
Keywords: Chronic inflammatory demyelinating polyradiculoneuropathy
CIDP
UCB7665
rozanolixizumab
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2019-08-09
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


Eligibility 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

Primary outcomes:
measure: Number of Participants With Treatment-emergent Adverse Event (TEAEs)
timeFrame: From Baseline until Follow-Up Visit (up to Week 84)
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Cidp04 50082
state: Arizona
city: Augusta
country: United States
facility: Cidp04 50075
state: Georgia
city: Charlotte
country: United States
facility: Cidp04 50117
state: North Carolina
city: Durham
country: United States
facility: Cidp04 50080
state: North Carolina
city: Gent
country: Belgium
facility: Cidp04 40169
city: Leuven
country: Belgium
facility: Cidp04 40002
city: Liège
country: Belgium
facility: Cidp04 40120
city: Copenhagen
country: Denmark
facility: Cidp04 40126
city: Strasbourg
country: France
facility: Cidp04 40170
city: Essen
country: Germany
facility: Cidp04 40134
city: Göttingen
country: Germany
facility: Cidp04 40140
city: Amsterdam
country: Netherlands
facility: Cidp04 40034
city: Barcelona
country: Spain
facility: Cidp04 40160
city: Sheffield
country: United Kingdom
facility: Cidp04 40167
Study officials:
affiliation: 001 844 599 2273 (UCB)
name: UCB Cares
role: STUDY_DIRECTOR
References: