A Study to Evaluate the Safe and Effective Use of the Prefilled Safety Syringe or the Auto-injector for the Subcutaneous Self-injection of Bimekizumab Solution by Subjects With Active Psoriatic Arthritis
NCT ID: NCT04109976
Last Updated: 2023-11-30
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE3
214 participants
INTERVENTIONAL
2019-08-13
2020-11-13
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Bimekizumab-SS
Study participants randomized to this arm will receive assigned bimekizumab dose regimen using the prefilled safety syringe (SS).
Bimekizumab
Study participants will receive bimekizumab at pre-specified time points.
Bimekizumab-AI
Study participants randomized to this arm will receive assigned bimekizumab dose regimen using the auto-injector (AI).
Bimekizumab
Study participants will receive bimekizumab at pre-specified time points.
Interventions
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Bimekizumab
Study participants will receive bimekizumab at pre-specified time points.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subject is willing to self-inject
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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Dv0004 50024
Boise, Idaho, United States
Dv0004 50028
Lexington, Kentucky, United States
Dv0004 50023
Baton Rouge, Louisiana, United States
Dv0004 50015
Hagerstown, Maryland, United States
Dv0004 50026
Wheaton, Maryland, United States
Dv0004 50019
Lansing, Michigan, United States
Dv0004 50016
St Louis, Missouri, United States
Dv0004 50005
Freehold, New Jersey, United States
Dv0004 50029
Albuquerque, New Mexico, United States
Dv0004 50010
Brooklyn, New York, United States
Dv0004 50125
Charlotte, North Carolina, United States
Dv0004 50031
Salisbury, North Carolina, United States
Dv0004 50040
Dayton, Ohio, United States
Dv0004 50020
Duncansville, Pennsylvania, United States
Dv0004 50006
Wyomissing, Pennsylvania, United States
Dv0004 50008
Johnston, Rhode Island, United States
Dv0004 50001
Jackson, Tennessee, United States
Dv0004 50036
Mesquite, Texas, United States
Dv0004 50009
Waco, Texas, United States
Dv0004 50050
Beckley, West Virginia, United States
Dv0004 40061
Brno, , Czechia
Dv0004 40009
Pardubice, , Czechia
Dv0004 40063
Prague, , Czechia
Dv0004 40066
Prague, , Czechia
Dv0004 40010
Uherské Hradiště, , Czechia
Dv0004 40012
Zlín, , Czechia
Dv0004 40029
Hamburg, , Germany
Dv0004 40079
Szentes, , Hungary
Dv0004 40038
Elblag, , Poland
Dv0004 40088
Elblag, , Poland
Dv0004 40096
Gdynia, , Poland
Dv0004 40042
Krakow, , Poland
Dv0004 40092
Krakow, , Poland
Dv0004 40037
Lublin, , Poland
Dv0004 40091
Nowa Sól, , Poland
Dv0004 40044
Poznan, , Poland
Dv0004 40118
Torun, , Poland
Dv0004 40041
Warsaw, , Poland
Dv0004 40097
Warsaw, , Poland
Dv0004 40098
Warsaw, , Poland
Dv0004 40039
Wroclaw, , Poland
Dv0004 40043
Wroclaw, , Poland
Dv0004 20005
Moscow, , Russia
Dv0004 20013
Petrozavodsk, , Russia
Dv0004 20004
Saint Petersburg, , Russia
Dv0004 20014
Ulyanovsk, , Russia
Dv0004 20015
Yaroslavl, , Russia
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Product Information
FDA Safety Alerts and Recalls
Other Identifiers
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2018-004725-86
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
DV0004
Identifier Type: -
Identifier Source: org_study_id