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)
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
1 other identifier
interventional
172
2 countries
39
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Dec 2018
39 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 5, 2018
CompletedFirst Posted
Study publicly available on registry
December 6, 2018
CompletedStudy Start
First participant enrolled
December 20, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 14, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 8, 2020
CompletedResults Posted
Study results publicly available
August 8, 2023
CompletedJuly 14, 2025
July 1, 2025
1.6 years
December 5, 2018
June 12, 2023
July 2, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
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
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 Outcomes (2)
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
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
Baseline (the first self-injection visit)
Study Arms (2)
Bimekizumab-SS
EXPERIMENTALSubjects will receive assigned bimekizumab dose regimen using a prefilled safety syringe (SS).
Bimekizumab-AI
EXPERIMENTALSubjects will receive assigned bimekizumab dose regimen using an auto-injector (AI).
Interventions
Subjects will receive bimekizumab at pre-specified time-points.
Eligibility Criteria
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (39)
Dv0002 946
Phoenix, Arizona, 85032, United States
Dv0002 910
Bakersfield, California, 93309, United States
Dv0002 955
San Diego, California, 92123, United States
Dv0002 943
San Luis Obispo, California, 93405, United States
Dv0002 967
Santa Monica, California, 90404, United States
Dv0002 906
Boca Raton, Florida, 33486, United States
Dv0002 907
Miami, Florida, 33144, United States
Dv0002 903
Ocala, Florida, 34471, United States
Dv0002 936
Tampa, Florida, 33624, United States
Dv0002 941
Alpharetta, Georgia, 30022, United States
Dv0002 954
Skokie, Illinois, 60077, United States
Dv0002 900
West Des Moines, Iowa, 50265, United States
Dv0002 905
Overland Park, Kansas, 66215, United States
Dv0002 962
Owensboro, Kentucky, 42301, United States
Dv0002 922
Baton Rouge, Louisiana, 70809, United States
Dv0002 925
Brighton, Massachusetts, 02135, United States
Dv0002 917
Troy, Michigan, 48084, United States
Dv0002 915
St Louis, Missouri, 63117, United States
Dv0002 901
Portsmouth, New Hampshire, 03801, United States
Dv0002 908
East Windsor, New Jersey, 08520, United States
Dv0002 913
New York, New York, 10029, United States
Dv0002 963
Rochester, New York, 14623, United States
Dv0002 920
Portland, Oregon, 97210, United States
Dv0002 929
Portland, Oregon, 97223, United States
Dv0002 937
Johnston, Rhode Island, 02919, United States
Dv0002 951
Houston, Texas, 77598, United States
Dv0002 914
San Antonio, Texas, 78213, United States
Dv0002 672
Edmonton, Canada
Dv0002 673
Halifax, Canada
Dv0002 671
Hamilton, Canada
Dv0002 675
Markham, Canada
Dv0002 663
Mississauga, Canada
Dv0002 660
Montreal, Canada
Dv0002 665
Québec, Canada
Dv0002 651
Richmond Hill, Canada
Dv0002 653
Toronto, Canada
Dv0002 662
Toronto, Canada
Dv0002 657
Waterloo, Canada
Dv0002 670
Windsor, Canada
Related Publications (2)
Sebastian M, Bagel J, Hoepken B, Knapp B, Bicer C, MacPherson M, Langley RG. Single-Injection Options for Administering a 320 mg Dose of Bimekizumab: 2 mL Safety Syringe and Auto-injector. Dermatol Ther (Heidelb). 2025 May;15(5):1113-1134. doi: 10.1007/s13555-025-01366-6. Epub 2025 Mar 29.
PMID: 40156698RESULTBagel 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.
PMID: 35133113DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- UCB
- Organization
- Cares
Study Officials
- STUDY DIRECTOR
UCB Cares
001 844 599 2273
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 5, 2018
First Posted
December 6, 2018
Study Start
December 20, 2018
Primary Completion
July 14, 2020
Study Completion
September 8, 2020
Last Updated
July 14, 2025
Results First Posted
August 8, 2023
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will not share