Psoriatic ArthritisPhase 3NCT04109976
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 Phase 3 study testing Bimekizumab in people with Psoriatic Arthritis, run by UCB Biopharma SRL at 47 sites in 6 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriatic Arthritis
- What is being tested?
- Bimekizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 214 participants
- Where
- 47 sitesin 6 countries
- Study dates
- 13 Aug 2019to 13 Nov 2020
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- -Subjects are not permitted to enroll in DV0004 if any of the PA0012 [NCT04009499] study exclusion criteria are met
Trial locations and contacts
47 sites in 6 countries.
47 sites in 6 countries
United States20 sites
Dv0004 50029
Albuquerque, New Mexico, 87102
Dv0004 50023
Baton Rouge, Louisiana, 70836
Dv0004 50050
Beckley, West Virginia, 25801
Dv0004 50024
Boise, Idaho, 83702
Dv0004 50010
Brooklyn, New York, 11201
Dv0004 50125
Charlotte, North Carolina, 28210
Dv0004 50040
Dayton, Ohio, 45417
Dv0004 50020
Duncansville, Pennsylvania, 16635
Dv0004 50005
Freehold, New Jersey, 07728
Dv0004 50015
Hagerstown, Maryland, 21742
Dv0004 50001
Jackson, Tennessee, 38305
Dv0004 50008
Johnston, Rhode Island, 02919
Dv0004 50019
Lansing, Michigan, 48910
Dv0004 50028
Lexington, Kentucky, 40504
Dv0004 50036
Mesquite, Texas, 75150
Dv0004 50031
Salisbury, North Carolina, 28144
Dv0004 50016
St Louis, Missouri, 63141
Dv0004 50009
Waco, Texas, 76710
Dv0004 50026
Wheaton, Maryland, 20902
Dv0004 50006
Wyomissing, Pennsylvania, 19610
Poland14 sites
Dv0004 40038
Elblag
Dv0004 40088
Elblag
Dv0004 40096
Gdynia
Dv0004 40042
Krakow
Dv0004 40092
Krakow
Dv0004 40037
Lublin
Dv0004 40091
Nowa Sól
Dv0004 40044
Poznan
Dv0004 40118
Torun
Dv0004 40041
Warsaw
Dv0004 40097
Warsaw
Dv0004 40098
Warsaw
Dv0004 40039
Wroclaw
Dv0004 40043
Wroclaw
Czechia6 sites
Dv0004 40061
Brno
Dv0004 40009
Pardubice
Dv0004 40063
Prague
Dv0004 40066
Prague
Dv0004 40010
Uherské Hradiště
Dv0004 40012
Zlín
Russia5 sites
Dv0004 20005
Moscow
Dv0004 20013
Petrozavodsk
Dv0004 20004
Saint Petersburg
Dv0004 20014
Ulyanovsk
Dv0004 20015
Yaroslavl
About this study
Official title: 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
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).
- Conditions
- Psoriatic Arthritis
- Being tested
- Bimekizumab
- Keywords
- Psoriatic Arthritis, PsA, Auto-Injector, Bimekizumab
- Medical subject headings
- Arthritis, Psoriatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BimekizumabDrug
Also called UCB4940, BKZ
Study participants will receive bimekizumab at pre-specified time points.
| Study group | Role | What they receive |
|---|---|---|
| Bimekizumab-SS | Experimental | Study participants randomized to this arm will receive assigned bimekizumab dose regimen using the prefilled safety syringe (SS). Receives: Drug: Bimekizumab |
| Bimekizumab-AI | Experimental | Study participants randomized to this arm will receive assigned bimekizumab dose regimen using the auto-injector (AI). Receives: Drug: Bimekizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
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).
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2019
- Study start13 Aug 2019
- Primary completion5 Nov 2020
- Study completion13 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Psoriatic ArthritisStudies of the same condition, open and under way.
- More trials run by UCB Biopharma SRLThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 214 participants (actual)
Sponsor and investigators
- Lead sponsor
- UCB Biopharma SRL
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- UCB Cares, Study director, 001 844 599 2273 (UCB)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04109976
- Sponsor's protocol ID
- DV0004
- Other IDs
- 2018-004725-86, 2018
- Status last verified
- Nov 2023
- First submitted
- 27 Sep 2019
- Last updated
- 30 Nov 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04109976
- Acronym / sponsor ID
- DV0004
- Conditions
- Psoriatic Arthritis
- Keywords
- Psoriatic Arthritis, PsA, Auto-Injector, Bimekizumab
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 214 participants (actual)
- Lead sponsor
- UCB Biopharma SRLIndustry (pharma, biotech, devices)
- Study start
- 13 Aug 2019 (actual)
- Primary completion
- 5 Nov 2020 (actual)
- Study completion
- 13 Nov 2020 (actual)
- First posted
- 1 Oct 2019 (actual)
- Results
- Posted 30 Nov 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bimekizumab-SS | Experimental | Drug: BimekizumabStudy participants randomized to this arm will receive assigned bimekizumab dose regimen using the prefilled safety syringe (SS). |
| Bimekizumab-AI | Experimental | Drug: BimekizumabStudy participants randomized to this arm will receive assigned bimekizumab dose regimen using the auto-injector (AI). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- -Subjects are not permitted to enroll in DV0004 if any of the PA0012 [NCT04009499] study exclusion criteria are met
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BimekizumabAlso: UCB4940, BKZStudy participants will receive bimekizumab at pre-specified time points. | Drug | Bimekizumab-AI, Bimekizumab-SS |
Primary outcome
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
Time frame: 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).
1 secondary outcome
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
Time frame: Baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Product InformationLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
UCB Cares study director
001 844 599 2273 (UCB)
47 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Bimekizumab in people with Psoriatic Arthritis, run by UCB Biopharma SRL at 47 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 47 sites in United States, Poland, Czechia, Russia, Germany and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2023; AzTrials last refreshed its copy on 28 Oct 2026.