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

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

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

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).

Study participants randomized to this arm will receive assigned bimekizumab dose regimen using the prefilled safety syringe (SS).

Study participants randomized to this arm will receive assigned bimekizumab dose regimen using the auto-injector (AI).

Percentage of participants able to self-administer safe and effective injections using the bimekizumab safety syringe (SS) or the bimekizumab auto-injector (AI) at Week 4

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 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 presentation for self-injection (ie, no serious ADEs (SADEs) and/or ADEs leading to withdrawal from the DV0004 substudy)

Percentage of participants able to self-administer safe and effective injections using the bimekizumab safety syringe (SS) or the bimekizumab auto-injector (AI) at Baseline

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 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 presentation for self-injection (ie, no SADEs and/or ADEs leading to withdrawal from the DV0004 substudy)

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

Data from this study may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.clinicalstudydatarequest.com and a signed data sharing agreement will need to be executed. All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal. This plan may change if a determination is made that the data cannot be adequately anonymized.

Data from this study may be requested by qualified researchers six months after product approval in the US and/or Europe or global development is discontinued, and 18 months after trial completion.

Qualified researchers may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.clinicalstudydatarequest.com and a signed data sharing agreement will need to be executed. All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal.