A Study to Assess the Efficacy, Safety and Tolerability of Rozanolixizumab in Subjects With Chronic Inflammatory Demyelinating Polyradiculoneuropathy
NCT ID: NCT03861481
Last Updated: 2023-08-01
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
34 participants
INTERVENTIONAL
2019-03-26
2021-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Rozanolixizumab
Subjects will be randomized to receive predefined subcutaneous doses of rozanolixizumab at a specified frequency
Rozanolixizumab
Subjects will receive rozanolixizumab in a specified sequence during the treatment period.
Placebo
Subjects will be randomized to receive predefined subcutaneous doses of placebo at a specified frequency
Placebo
Subjects will receive placebo 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.
Placebo
Subjects will receive placebo in a specified sequence during the treatment period.
Eligibility Criteria
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Inclusion Criteria
* Subject has a documented definite or probable diagnosis of Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) according to the European Federation of Neurological Societies (EFNS)/ Peripheral Nerve Society (PNS) criteria 2010
* Subject has an immunoglobulin-dependency confirmed by clinical examination during therapy or upon interruption or reduction of therapy within 18 months prior to Screening and documented in medical history
* Subject is on a stable dosage (not more than ±20% deviation) for subcutaneous immunoglobulin (SCIg) or intravenous immunoglobulin (IVIg) and a fixed interval for at least 4 months of either treatment
* 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
* Current diagnosis or has a history of Type 1 or Type 2 diabetes mellitus and/or hemoglobin A1c level \>6.0 %
* Known immunoglobulin M (IgM)-mediated neuropathy
* Clinical or known evidence of associated systemic diseases that might cause neuropathy or treatment with agents that might lead to neuropathy
* History of clinically relevant ongoing chronic infections
* Family history of primary immunodeficiency
* Received a live vaccination within 8 weeks prior to the Baseline Visit; or intends to have a live vaccination during the course of the study or within 7 weeks following the final dose of IMP
* Received any experimental biological agent within or outside of a clinical study in the past 3 months or within 5 half-lives prior to Baseline
* Prior treatment with rituximab, ofatumumab, or ocrelizumab in the 6 months prior to the Baseline Visit or subject has had prior treatment with rituximab, ofatumumab, or ocrelizumab in the 12 months prior to Baseline and B cells are not within the normal range
* Female subject who is pregnant or lactating
18 Years
ALL
No
Sponsors
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UCB Biopharma S.P.R.L.
INDUSTRY
Responsible Party
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Principal Investigators
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UCB Cares
Role: STUDY_DIRECTOR
+1 844 599 2273 (UCB)
Locations
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Cidp01 902
Phoenix, Arizona, United States
Cidp01 905
Los Angeles, California, United States
Cidp01 901
Tampa, Florida, United States
Cidp01 907
Augusta, Georgia, United States
Cidp01 911
Lexington, Kentucky, United States
Cidp01 903
Charlotte, North Carolina, United States
Cidp01 912
Durham, North Carolina, United States
Cidp01 101
Ghent, , Belgium
Cidp01 102
Leuven, , Belgium
Cidp01 103
Liège, , Belgium
Cidp01 302
Copenhagen, , Denmark
Cidp01 402
Bordeaux, , France
Cidp01 404
Nice, , France
Cidp01 401
Strasbourg, , France
Cidp01 501
Berlin, , Germany
Cidp01 503
Essen, , Germany
Cidp01 505
Göttingen, , Germany
Cidp01 502
Würzburg, , Germany
Cidp01 601
Amsterdam, , Netherlands
Cidp01 701
Barcelona, , Spain
Cidp01 702
Barcelona, , Spain
Cidp01 802
Sheffield, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2016-002411-17
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CIDP01
Identifier Type: -
Identifier Source: org_study_id
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