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

• ClinicalTrials.gov Identifier: NCT04109976
• Recruitment Status: Completed
• First Posted: October 1, 2019
• Results First Posted: November 30, 2023
• Last Update Posted: November 30, 2023
• Sponsor: UCB Biopharma SRL
• Information provided by (Responsible Party): UCB Pharma ( UCB Biopharma SRL )

Tracking Information

• First Submitted Date: September 27, 2019
• First Posted Date: October 1, 2019
• Results First Submitted Date: November 2, 2023
• Results First Posted Date: November 30, 2023
• Last Update Posted Date: November 30, 2023
• Actual Study Start Date: August 13, 2019
• Actual Primary Completion Date: November 5, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 2, 2023)

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).

Original Primary Outcome Measures (submitted: September 27, 2019)

Percentage of participants able to self-administer safe and effective injections using the bimekizumab safety syringe (SS) or the bimekizumab auto-injector (AI) at Week 4 [ Time Frame: Week 4 ]

Safe and effective self-injection will be evaluated by the study personnel and is defined as:

• Complete dose delivery: Subject self-injects the complete dose of bimekizumab as confirmed by a visual inspection of the bimekizumab-SS or the bimekizumab-AI which shows that the investigational medicinal product (IMP) is delivered completely (ie, container is empty), and
• No adverse device effects (ADEs) that would preclude continued use of the device presentation for self-injection (ie, no serious ADEs (SADEs) and/or ADEs leading to withdrawal from the DV0004 substudy)

Current Secondary Outcome Measures (submitted: November 2, 2023)

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).

Original Secondary Outcome Measures (submitted: September 27, 2019)

Percentage of participants able to self-administer safe and effective injections using the bimekizumab safety syringe (SS) or the bimekizumab auto-injector (AI) at Baseline [ Time Frame: Baseline ]

Safe and effective self-injection will be evaluated by the study personnel and is defined as:

• Complete dose delivery: Subject self-injects the complete dose of bimekizumab as confirmed by a visual inspection of the bimekizumab-SS or the bimekizumab-AI which shows that the investigational medicinal product (IMP) is delivered completely (ie, container is empty), and
• No adverse device effects (ADEs) that would preclude continued use of the device presentation for self-injection (ie, no SADEs and/or ADEs leading to withdrawal from the DV0004 substudy)

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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
• 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 Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Psoriatic Arthritis

Intervention

Drug: Bimekizumab

Study participants will receive bimekizumab at pre-specified time points.

Other Names:

• UCB4940
• BKZ

Study Arms

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

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: July 7, 2022): 214
• Original Estimated Enrollment (submitted: September 27, 2019): 200
• Actual Study Completion Date: November 13, 2020
• Actual Primary Completion Date: November 5, 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Czechia, Germany, Hungary, Poland, Russian Federation, United States

Administrative Information

• NCT Number: NCT04109976
• Other Study ID Numbers: DV0004; 2018-004725-86 ( EudraCT Number )
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• 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

IPD Sharing Statement

• Plan to Share IPD: Yes
• 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.
• Supporting Materials: Study Protocol
• Supporting Materials: Statistical Analysis Plan (SAP)
• Supporting Materials: Clinical Study Report (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.
• URL: http://clinicalstudydatarequest.com

• Current Responsible Party: UCB Pharma ( UCB Biopharma SRL )
• Original Responsible Party: UCB Biopharma S.P.R.L.
• Current Study Sponsor: UCB Biopharma SRL
• Original Study Sponsor: UCB Biopharma S.P.R.L.
• Collaborators: Not Provided

Investigators

• Study Director: UCB Cares; 001 844 599 2273 (UCB)

• PRS Account: UCB Pharma
• Verification Date: November 2023