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 Moderate to Severe Chronic Plaque Psoriasis (PSO)

• ClinicalTrials.gov Identifier: NCT03766685
• Recruitment Status: Completed
• First Posted: December 6, 2018
• Results First Posted: August 8, 2023
• Last Update Posted: August 8, 2023
• Sponsor: UCB Biopharma SRL
• Information provided by (Responsible Party): UCB Pharma ( UCB Biopharma SRL )

Tracking Information

• First Submitted Date: December 5, 2018
• First Posted Date: December 6, 2018
• Results First Submitted Date: June 12, 2023
• Results First Posted Date: August 8, 2023
• Last Update Posted Date: August 8, 2023
• Actual Study Start Date: December 20, 2018
• Actual Primary Completion Date: July 14, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 12, 2023)

• Percentage of Participants Able to Self-administer Safe and Effective Injections Using the Bimekizumab-safety Syringe (SS)-1mL or the Bimekizumab-auto-injector (AI)-1mL at Week 8, After Training in Self-injection Technique [ Time Frame: Week 8 ]
  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).
• Percentage of Participants Able to Self-administer Safe and Effective Injections Using the Bimekizumab-SS-2mL or the Bimekizumab-AI-2mL at Week 8, After Training in Self-injection Technique [ Time Frame: Week 8 ]
  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 serious ADEs (SADEs) and/or ADEs leading to withdrawal).

Original Primary Outcome Measures (submitted: December 5, 2018)

Percentage of subjects able to self-administer safe and effective injections using the bimekizumab-safety syringe (SS) or the bimekizumab-auto-injector (AI) respectively at Week 8 [ Time Frame: Week 8 ]

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-safety syringe (SS) or the bimekizumab-auto-injector (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 for self-injection (ie, no serious ADEs (SADEs) and/or ADEs leading to withdrawal)

Current Secondary Outcome Measures (submitted: June 12, 2023)

• Percentage of Participants Able to Self-administer Safe and Effective Injections Using the Bimekizumab-SS-1mL or the Bimekizumab-AI-1mL at Baseline, After Training in Self-injection Technique [ Time Frame: Baseline (the first self-injection visit) ]
  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 showed that the IMP was 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).
• Percentage of Participants Able to Self-administer Safe and Effective Injections Using the Bimekizumab-SS-2mL or the Bimekizumab-AI-2mL at Baseline, After Training in Self-injection Technique [ Time Frame: Baseline (the first self-injection visit) ]
  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: December 5, 2018)

Percentage of subjects able to self-administer safe and effective injections using the bimekizumab-SS or the bimekizumab-AI at Baseline [ Time Frame: Baseline (the first self-injection visit) ]

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 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)

• 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 Moderate to Severe Chronic Plaque Psoriasis (PSO)
• Official Title: A Multicenter, Randomized, Open-Label 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 Moderate to Severe Chronic Plaque Psoriasis
• Brief Summary: The purpose of the study is to evaluate the ability of subjects with moderate to severe chronic plaque psoriasis (PSO) to safely and effectively self-inject bimekizumab at study start and 8 weeks after training in self-injection technique using a prefilled safety syringe or an auto-injector.
• 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

• Chronic Plaque Psoriasis
• Moderate to Severe Chronic Plaque Psoriasis

Intervention

Drug: Bimekizumab

Subjects will receive bimekizumab at pre-specified time-points.

Other Names:

• UCB4940
• BKZ

Study Arms

• Experimental: Bimekizumab-SS
  Subjects will receive assigned bimekizumab dose regimen using a prefilled safety syringe (SS).
  Intervention: Drug: Bimekizumab
• Experimental: Bimekizumab-AI
  Subjects will receive assigned bimekizumab dose regimen using an auto-injector (AI).
  Intervention: Drug: Bimekizumab

• Publications *: Bagel J, Tatla D, Hellot S, Knapp B, Murphy C, Peterson L, Sebastian M. Bimekizumab Self-Injection Devices: Two Multicenter, Randomized, Open-Label Studies on Self-Administration by Patients With Psoriasis. J Drugs Dermatol. 2022 Feb 1;21(2):162-171. doi: 10.36849/jdd.6274.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 14, 2020): 172
• Original Estimated Enrollment (submitted: December 5, 2018): 255
• Actual Study Completion Date: September 8, 2020
• Actual Primary Completion Date: July 14, 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Subject fulfills all inclusion criteria for the PS0014 [NCT03598790] study
• Subject is considered reliable and capable of adhering to the DV0002 protocol (eg, able to understand and complete questionnaires, willing to self-inject, able to use investigational device according to the instructions for use (IFU), and able to adhere to the visit schedule) according to the judgment of the Investigator

Exclusion Criteria:

• Subjects are not permitted to enroll in DV0002 if any of the PS0014 [NCT03598790] 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: Canada, United States

Administrative Information

• NCT Number: NCT03766685
• Other Study ID Numbers: DV0002
• 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: No

• 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

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