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

Study Overview
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Brief Summary
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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).

Official Title
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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

Conditions
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Psoriatic Arthritis

Intervention / Treatment
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* Drug: Bimekizumab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bimekizumab-SS<br>Study participants randomized to this arm will receive assigned bimekizumab dose regimen using the prefilled safety syringe (SS). | Drug: Bimekizumab<br>* Study participants will receive bimekizumab at pre-specified time points.<br>* Other names: BKZ;|
| Experimental: Bimekizumab-AI<br>Study participants randomized to this arm will receive assigned bimekizumab dose regimen using the auto-injector (AI). | Drug: Bimekizumab<br>* Study participants will receive bimekizumab at pre-specified time points.<br>* Other names: BKZ;|

What is the study measuring?
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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 (BKZ-SS) or the Bimekizumab Auto-injector (BKZ-AI) at 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). | Week 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Psoriatic Arthritis, PsA, Auto-Injector, Bimekizumab