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
A Multicenter, Randomized, Open-Label Study to Evaluate the Safe and Effective Use of the Prefilled Safety Syringe or Auto-Injector for the Subcutaneous Self-Injection of Bimekizumab Solution by Subjects With Active Psoriatic Arthritis
2 other identifiers
interventional
214
6 countries
47
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Aug 2019
Shorter than P25 for phase_3
47 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 13, 2019
CompletedFirst Submitted
Initial submission to the registry
September 27, 2019
CompletedFirst Posted
Study publicly available on registry
October 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 5, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
November 13, 2020
CompletedResults Posted
Study results publicly available
November 30, 2023
CompletedNovember 30, 2023
November 1, 2023
1.2 years
September 27, 2019
November 2, 2023
November 29, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
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).
Week 4
Secondary Outcomes (1)
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
Study Arms (2)
Bimekizumab-SS
EXPERIMENTALStudy participants randomized to this arm will receive assigned bimekizumab dose regimen using the prefilled safety syringe (SS).
Bimekizumab-AI
EXPERIMENTALStudy participants randomized to this arm will receive assigned bimekizumab dose regimen using the auto-injector (AI).
Interventions
Study participants will receive bimekizumab at pre-specified time points.
Eligibility Criteria
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (47)
Dv0004 50024
Boise, Idaho, 83702, United States
Dv0004 50028
Lexington, Kentucky, 40504, United States
Dv0004 50023
Baton Rouge, Louisiana, 70836, United States
Dv0004 50015
Hagerstown, Maryland, 21742, United States
Dv0004 50026
Wheaton, Maryland, 20902, United States
Dv0004 50019
Lansing, Michigan, 48910, United States
Dv0004 50016
St Louis, Missouri, 63141, United States
Dv0004 50005
Freehold, New Jersey, 07728, United States
Dv0004 50029
Albuquerque, New Mexico, 87102, United States
Dv0004 50010
Brooklyn, New York, 11201, United States
Dv0004 50125
Charlotte, North Carolina, 28210, United States
Dv0004 50031
Salisbury, North Carolina, 28144, United States
Dv0004 50040
Dayton, Ohio, 45417, United States
Dv0004 50020
Duncansville, Pennsylvania, 16635, United States
Dv0004 50006
Wyomissing, Pennsylvania, 19610, United States
Dv0004 50008
Johnston, Rhode Island, 02919, United States
Dv0004 50001
Jackson, Tennessee, 38305, United States
Dv0004 50036
Mesquite, Texas, 75150, United States
Dv0004 50009
Waco, Texas, 76710, United States
Dv0004 50050
Beckley, West Virginia, 25801, 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
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- UCB
- Organization
- Cares
Study Officials
- STUDY DIRECTOR
UCB Cares
001 844 599 2273 (UCB)
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 27, 2019
First Posted
October 1, 2019
Study Start
August 13, 2019
Primary Completion
November 5, 2020
Study Completion
November 13, 2020
Last Updated
November 30, 2023
Results First Posted
November 30, 2023
Record last verified: 2023-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Data from this study may be requested by qualified researchers six months after product approval in the US and/or Europe or global development is discontinued, and 18 months after trial completion.
- Access Criteria
- Qualified researchers may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.clinicalstudydatarequest.com and a signed data sharing agreement will need to be executed. All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal.
Data from this study may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.clinicalstudydatarequest.com and a signed data sharing agreement will need to be executed. All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal. This plan may change if a determination is made that the data cannot be adequately anonymized.