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)

July 19, 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 the Auto-Injector for the Subcutaneous Self-Injection of Bimekizumab Solution by Subjects With Moderate to Severe Chronic Plaque Psoriasis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

172

Phase

  • 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

  • Canada
      • Edmonton, Canada
        • Dv0002 672
      • Halifax, Canada
        • Dv0002 673
      • Hamilton, Canada
        • Dv0002 671
      • Markham, Canada
        • Dv0002 675
      • Mississauga, Canada
        • Dv0002 663
      • Montréal, Canada
        • Dv0002 660
      • Québec City, Canada
        • Dv0002 665
      • Richmond Hill, Canada
        • Dv0002 651
      • Toronto, Canada
        • Dv0002 653
      • Toronto, Canada
        • Dv0002 662
      • Waterloo, Canada
        • Dv0002 657
      • Windsor, Canada
        • Dv0002 670
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85032
        • Dv0002 946
    • California
      • Bakersfield, California, United States, 93309
        • Dv0002 910
      • San Diego, California, United States, 92123
        • Dv0002 955
      • San Luis Obispo, California, United States, 93405
        • Dv0002 943
      • Santa Monica, California, United States, 90404
        • Dv0002 967
    • Florida
      • Boca Raton, Florida, United States, 33486
        • Dv0002 906
      • Miami, Florida, United States, 33144
        • Dv0002 907
      • Ocala, Florida, United States, 34471
        • Dv0002 903
      • Tampa, Florida, United States, 33624
        • Dv0002 936
    • Georgia
      • Alpharetta, Georgia, United States, 30022
        • Dv0002 941
    • Illinois
      • Skokie, Illinois, United States, 60077
        • Dv0002 954
    • Iowa
      • West Des Moines, Iowa, United States, 50265
        • Dv0002 900
    • Kansas
      • Overland Park, Kansas, United States, 66215
        • Dv0002 905
    • Kentucky
      • Owensboro, Kentucky, United States, 42301
        • Dv0002 962
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70809
        • Dv0002 922
    • Massachusetts
      • Brighton, Massachusetts, United States, 02135
        • Dv0002 925
    • Michigan
      • Troy, Michigan, United States, 48084
        • Dv0002 917
    • Missouri
      • Saint Louis, Missouri, United States, 63117
        • Dv0002 915
    • New Hampshire
      • Portsmouth, New Hampshire, United States, 03801
        • Dv0002 901
    • New Jersey
      • East Windsor, New Jersey, United States, 08520
        • Dv0002 908
    • New York
      • New York, New York, United States, 10029
        • Dv0002 913
      • Rochester, New York, United States, 14623
        • Dv0002 963
    • Oregon
      • Portland, Oregon, United States, 97210
        • Dv0002 920
      • Portland, Oregon, United States, 97223
        • Dv0002 929
    • Rhode Island
      • Johnston, Rhode Island, United States, 02919
        • Dv0002 937
    • Texas
      • Houston, Texas, United States, 77598
        • Dv0002 951
      • San Antonio, Texas, United States, 78213
        • Dv0002 914

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

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 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

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
Intervention / Treatment
Experimental: Bimekizumab-SS
Subjects will receive assigned bimekizumab dose regimen using a prefilled safety syringe (SS).
Drug: Bimekizumab
Subjects will receive bimekizumab at pre-specified time-points.
Other Names:
  • UCB4940
  • BKZ
Experimental: Bimekizumab-AI
Subjects will receive assigned bimekizumab dose regimen using an auto-injector (AI).
Drug: Bimekizumab
Subjects will receive bimekizumab at pre-specified time-points.
Other Names:
  • UCB4940
  • BKZ

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Week 8
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).
Week 8

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Baseline (the first self-injection visit)
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).
Baseline (the first self-injection visit)

Collaborators and Investigators

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

Sponsor

UCB Biopharma SRL

Investigators

  • Study Director: UCB Cares, 001 844 599 2273

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.

General Publications

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)

December 20, 2018

Primary Completion (Actual)

July 14, 2020

Study Completion (Actual)

September 8, 2020

Study Registration Dates

First Submitted

December 5, 2018

First Submitted That Met QC Criteria

December 5, 2018

First Posted (Actual)

December 6, 2018

Study Record Updates

Last Update Posted (Actual)

August 8, 2023

Last Update Submitted That Met QC Criteria

July 19, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DV0002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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