A Study to Assess Long-term Safety, Tolerability and Efficacy of Rozanolixizumab in Subjects With Chronic Inflammatory Demyelinating Polyradiculoneuropathy
NCT ID: NCT04051944
Last Updated: 2022-11-03
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
21 participants
INTERVENTIONAL
2019-08-21
2021-11-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Rozanolixizumab
Subjects in this arm will receive predefined subcutaneous doses of rozanolixizumab at a specified frequency.
Rozanolixizumab
Subjects will receive rozanolixizumab in a specified sequence during the treatment period.
Interventions
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Rozanolixizumab
Subjects will receive rozanolixizumab in a specified sequence during the treatment period.
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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UCB Biopharma SRL
INDUSTRY
Responsible Party
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Principal Investigators
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UCB Cares
Role: STUDY_DIRECTOR
001 844 599 2273 (UCB)
Locations
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Cidp04 50082
Scottsdale, Arizona, United States
Cidp04 50075
Augusta, Georgia, United States
Cidp04 50117
Charlotte, North Carolina, United States
Cidp04 50080
Durham, North Carolina, United States
Cidp04 40169
Ghent, , Belgium
Cidp04 40002
Leuven, , Belgium
Cidp04 40120
Liège, , Belgium
Cidp04 40126
Copenhagen, , Denmark
Cidp04 40170
Strasbourg, , France
Cidp04 40134
Essen, , Germany
Cidp04 40140
Göttingen, , Germany
Cidp04 40034
Amsterdam, , Netherlands
Cidp04 40160
Barcelona, , Spain
Cidp04 40167
Sheffield, , United Kingdom
Countries
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References
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Querol L, De Seze J, Dysgaard T, Levine T, Rao TH, Rivner M, Hartung HP, Kiessling P, Shimizu S, Marmol D, Bozorg A, Colson AO, Massow U, Eftimov F; CIDP01 Study Investigators. Efficacy, safety and tolerability of rozanolixizumab in patients with chronic inflammatory demyelinating polyradiculoneuropathy: a randomised, subject-blind, investigator-blind, placebo-controlled, phase 2a trial and open-label extension study. J Neurol Neurosurg Psychiatry. 2024 Aug 16;95(9):845-854. doi: 10.1136/jnnp-2023-333112.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2018-004392-12
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CIDP04
Identifier Type: -
Identifier Source: org_study_id
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