Status:
COMPLETED
A Study to Assess Long-term Safety, Tolerability and Efficacy of Rozanolixizumab in Subjects With Chronic Inflammatory Demyelinating Polyradiculoneuropathy
Lead Sponsor:
UCB Biopharma SRL
Conditions:
Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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
- 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
- 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
Key Trial Info
Start Date :
August 21 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 10 2021
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT04051944
Start Date
August 21 2019
End Date
November 10 2021
Last Update
November 3 2022
Active Locations (14)
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1
Cidp04 50082
Scottsdale, Arizona, United States, 85251
2
Cidp04 50075
Augusta, Georgia, United States, 30912
3
Cidp04 50117
Charlotte, North Carolina, United States, 28210
4
Cidp04 50080
Durham, North Carolina, United States, 27710