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

Phase 3

Completed

Conditions: Psoriatic Arthritis

Interventions: Drug: Bimekizumab

Registration Number: NCT04109976

Lead Sponsor: UCB Biopharma SRL

Brief Summary: The purpose of the study is to evaluate for each self-injecting device presentation the ability of subjects with psoriatic arthritis (PsA) to safely and effectively self-inject bimekizumab at study start and 4 weeks after training in self-injection technique using the bimekizumab safety syringe (SS) or the bimekizumab auto-injector (AI).

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 214

Inclusion Criteria

Subject fulfills all inclusion criteria for the PA0012 [NCT04009499] study
Subject is considered reliable and capable of adhering to the DV0004 protocol (eg, able to understand and complete questionnaires, able to use investigational self-injecting device presentations according to the instructions for use (IFU), and able to adhere to the visit schedule) according to the judgment of the Investigator
Subject is willing to self-inject

Exclusion Criteria

-Subjects are not permitted to enroll in DV0004 if any of the PA0012 [NCT04009499] study exclusion criteria are met

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bimekizumab-AI	Bimekizumab	Study participants randomized to this arm will receive assigned bimekizumab dose regimen using the auto-injector (AI).
Bimekizumab-SS	Bimekizumab	Study participants randomized to this arm will receive assigned bimekizumab dose regimen using the prefilled safety syringe (SS).

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Able to Self-administer Safe and Effective Injections Using the Bimekizumab Safety Syringe (BKZ-SS) or the Bimekizumab Auto-injector (BKZ-AI) at Week 4	Week 4	Safe and effective self-injection was evaluated by the study personnel and was defined as: - Complete dose delivery: Participant self-injected the complete dose of bimekizumab as confirmed by a visual inspection of the bimekizumab-safety syringe (SS) or the bimekizumab-auto-injector (AI) which shows that the investigational medicinal product (IMP) was delivered completely (ie, container is empty), and - No Adverse Device Effects (ADEs) that would preclude continued use of the device for self-injection (ie, no serious ADEs (SADEs) and/or ADEs leading to withdrawal).

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants Able to Self-administer Safe and Effective Injections Using the Bimekizumab Safety Syringe (BKZ-SS) or the Bimekizumab Auto-injector (BKZ-AI) at Baseline	Baseline	Safe and effective self-injection was evaluated by the study personnel and was defined as: - Complete dose delivery: Participant self-injected the complete dose of bimekizumab as confirmed by a visual inspection of the bimekizumab-SS or the bimekizumab-AI which shows that the IMP is delivered completely (ie, container is empty), and - No ADEs that would preclude continued use of the device for self-injection (ie, no SADEs and/or ADEs leading to withdrawal).

Trial Locations

Locations (47): Dv0004 40097
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Warsaw, Poland
Dv0004 50125
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Charlotte, North Carolina, United States
Dv0004 50024
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Boise, Idaho, United States
Dv0004 50036
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Mesquite, Texas, United States
Dv0004 50023
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Baton Rouge, Louisiana, United States
Dv0004 50015
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Hagerstown, Maryland, United States
Dv0004 50026
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Wheaton, Maryland, United States
Dv0004 40061
🇨🇿
Brno, Czechia
Dv0004 50019
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Lansing, Michigan, United States
Dv0004 50016
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Saint Louis, Missouri, United States
Dv0004 40044
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Poznań, Poland
Dv0004 40098
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Warszawa, Poland
Dv0004 40012
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Zlín, Czechia
Dv0004 50001
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Jackson, Tennessee, United States
Dv0004 40066
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Praha 2, Czechia
Dv0004 40038
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Elbląg, Poland
Dv0004 50050
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Beckley, West Virginia, United States
Dv0004 40009
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Pardubice, Czechia
Dv0004 40063
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Praha 5, Czechia
Dv0004 20015
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Yaroslavl, Russian Federation
Dv0004 50005
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Freehold, New Jersey, United States
Dv0004 50010
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Brooklyn, New York, United States
Dv0004 50031
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Salisbury, North Carolina, United States
Dv0004 50040
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Dayton, Ohio, United States
Dv0004 50020
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Duncansville, Pennsylvania, United States
Dv0004 50006
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Wyomissing, Pennsylvania, United States
Dv0004 50008
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Johnston, Rhode Island, United States
Dv0004 50009
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Waco, Texas, United States
Dv0004 40010
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Uherské Hradiště, Czechia
Dv0004 40079
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Szentes, Hungary
Dv0004 40029
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Hamburg, Germany
Dv0004 40092
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Kraków, Poland
Dv0004 40042
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Kraków, Poland
Dv0004 40118
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Toruń, Poland
Dv0004 20005
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Moscow, Russian Federation
Dv0004 20013
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Petrozavodsk, Russian Federation
Dv0004 40043
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Wrocław, Poland
Dv0004 20004
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Saint Petersburg, Russian Federation
Dv0004 20014
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Ulyanovsk, Russian Federation
Dv0004 40037
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Lublin, Poland
Dv0004 40091
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Nowa Sól, Poland
Dv0004 40096
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Gdynia, Poland
Dv0004 40041
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Warsaw, Poland
Dv0004 40039
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Wrocław, Poland
Dv0004 40088
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Elbląg, Poland
Dv0004 50028
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Lexington, Kentucky, United States
Dv0004 50029
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Albuquerque, New Mexico, United States