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

November 29, 2023 updated by: UCB Biopharma SRL

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
214

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
      • Brno, Czechia
        • Dv0004 40061
      • Pardubice, Czechia
        • Dv0004 40009
      • Praha 2, Czechia
        • Dv0004 40066
      • Praha 5, Czechia
        • Dv0004 40063
      • Uherské Hradiště, Czechia
        • Dv0004 40010
      • Zlín, Czechia
        • Dv0004 40012
  • Germany
      • Hamburg, Germany
        • Dv0004 40029
  • Hungary
      • Szentes, Hungary
        • Dv0004 40079
  • Poland
      • Elbląg, Poland
        • Dv0004 40038
      • Elbląg, Poland
        • Dv0004 40088
      • Gdynia, Poland
        • Dv0004 40096
      • Kraków, Poland
        • Dv0004 40042
      • Kraków, Poland
        • Dv0004 40092
      • Lublin, Poland
        • Dv0004 40037
      • Nowa Sól, Poland
        • Dv0004 40091
      • Poznań, Poland
        • Dv0004 40044
      • Toruń, Poland
        • Dv0004 40118
      • Warsaw, Poland
        • Dv0004 40041
      • Warsaw, Poland
        • Dv0004 40097
      • Warszawa, Poland
        • Dv0004 40098
      • Wrocław, Poland
        • Dv0004 40039
      • Wrocław, Poland
        • Dv0004 40043
  • Russian Federation
      • Moscow, Russian Federation
        • Dv0004 20005
      • Petrozavodsk, Russian Federation
        • Dv0004 20013
      • Saint Petersburg, Russian Federation
        • Dv0004 20004
      • Ulyanovsk, Russian Federation
        • Dv0004 20014
      • Yaroslavl, Russian Federation
        • Dv0004 20015
  • United States
    • Idaho
      • Boise, Idaho, United States, 83702
        • Dv0004 50024
    • Kentucky
      • Lexington, Kentucky, United States, 40504
        • Dv0004 50028
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70836
        • Dv0004 50023
    • Maryland
      • Hagerstown, Maryland, United States, 21742
        • Dv0004 50015
      • Wheaton, Maryland, United States, 20902
        • Dv0004 50026
    • Michigan
      • Lansing, Michigan, United States, 48910
        • Dv0004 50019
    • Missouri
      • Saint Louis, Missouri, United States, 63141
        • Dv0004 50016
    • New Jersey
      • Freehold, New Jersey, United States, 07728
        • Dv0004 50005
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • Dv0004 50029
    • New York
      • Brooklyn, New York, United States, 11201
        • Dv0004 50010
    • North Carolina
      • Charlotte, North Carolina, United States, 28210
        • Dv0004 50125
      • Salisbury, North Carolina, United States, 28144
        • Dv0004 50031
    • Ohio
      • Dayton, Ohio, United States, 45417
        • Dv0004 50040
    • Pennsylvania
      • Duncansville, Pennsylvania, United States, 16635
        • Dv0004 50020
      • Wyomissing, Pennsylvania, United States, 19610
        • Dv0004 50006
    • Rhode Island
      • Johnston, Rhode Island, United States, 02919
        • Dv0004 50008
    • Tennessee
      • Jackson, Tennessee, United States, 38305
        • Dv0004 50001
    • Texas
      • Mesquite, Texas, United States, 75150
        • Dv0004 50036
      • Waco, Texas, United States, 76710
        • Dv0004 50009
    • West Virginia
      • Beckley, West Virginia, United States, 25801
        • Dv0004 50050

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Bimekizumab-SS
Study participants randomized to this arm will receive assigned bimekizumab dose regimen using the prefilled safety syringe (SS).
Drug: Bimekizumab
Study participants will receive bimekizumab at pre-specified time points.
Other Names:
  • UCB4940
  • BKZ
Experimental: Bimekizumab-AI
Study participants randomized to this arm will receive assigned bimekizumab dose regimen using the auto-injector (AI).
Drug: Bimekizumab
Study participants will receive bimekizumab at pre-specified time points.
Other Names:
  • UCB4940
  • BKZ

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
Week 4

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
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).
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
UCB Biopharma SRL

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: UCB Cares, 001 844 599 2273 (UCB)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 13, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 5, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 13, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 27, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 27, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 1, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 30, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 29, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DV0004
  • 2018-004725-86 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing 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.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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