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)

Phase 3

Completed

Conditions: Moderate to Severe Chronic Plaque Psoriasis
Chronic Plaque Psoriasis

Interventions: Drug: Bimekizumab

Registration Number: NCT03766685

Lead Sponsor: UCB Biopharma SRL

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 available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 172

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bimekizumab-SS	Bimekizumab	Subjects will receive assigned bimekizumab dose regimen using a prefilled safety syringe (SS).
Bimekizumab-AI	Bimekizumab	Subjects will receive assigned bimekizumab dose regimen using an auto-injector (AI).

Primary Outcome Measures

Name	Time	Method
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	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	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).

Secondary Outcome Measures

Name	Time	Method
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)	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).
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)	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).

Trial Locations

Locations (39): Dv0002 962
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Owensboro, Kentucky, United States
Dv0002 651
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Richmond Hill, Canada
Dv0002 670
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Windsor, Canada
Dv0002 967
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Santa Monica, California, United States
Dv0002 963
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Rochester, New York, United States
Dv0002 671
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Hamilton, Canada
Dv0002 675
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Markham, Canada
Dv0002 946
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Phoenix, Arizona, United States
Dv0002 936
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Tampa, Florida, United States
Dv0002 943
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San Luis Obispo, California, United States
Dv0002 925
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Brighton, Massachusetts, United States
Dv0002 900
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West Des Moines, Iowa, United States
Dv0002 929
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Portland, Oregon, United States
Dv0002 903
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Ocala, Florida, United States
Dv0002 906
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Boca Raton, Florida, United States
Dv0002 954
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Skokie, Illinois, United States
Dv0002 913
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New York, New York, United States
Dv0002 955
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San Diego, California, United States
Dv0002 672
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Edmonton, Canada
Dv0002 915
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Saint Louis, Missouri, United States
Dv0002 662
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Toronto, Canada
Dv0002 908
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East Windsor, New Jersey, United States
Dv0002 951
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Houston, Texas, United States
Dv0002 673
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Halifax, Canada
Dv0002 663
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Mississauga, Canada
Dv0002 660
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Montréal, Canada
Dv0002 910
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Bakersfield, California, United States
Dv0002 907
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Miami, Florida, United States
Dv0002 941
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Alpharetta, Georgia, United States
Dv0002 901
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Portsmouth, New Hampshire, United States
Dv0002 920
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Portland, Oregon, United States
Dv0002 937
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Johnston, Rhode Island, United States
Dv0002 657
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Waterloo, Canada
Dv0002 905
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Overland Park, Kansas, United States
Dv0002 922
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Baton Rouge, Louisiana, United States
Dv0002 665
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Québec City, Canada
Dv0002 653
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Toronto, Canada
Dv0002 914
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San Antonio, Texas, United States
Dv0002 917
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Troy, Michigan, United States