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

UCB Biopharma SRL214 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

214

Conditions

Psoriatic Arthritis

Interventions

BimekizumabDRUG

Study participants will receive bimekizumab at pre-specified time points.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (47)

Outcomes

Primary Outcomes

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).

Time frame: Week 4

Secondary Outcomes

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).

Time frame: Baseline

Data from ClinicalTrials.gov

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Dv0004 50024

Boise, Idaho, United States

Dv0004 50028

Lexington, Kentucky, United States

Dv0004 50023

Baton Rouge, Louisiana, United States

Dv0004 50015

Hagerstown, Maryland, United States

Dv0004 50026

Wheaton, Maryland, United States

Dv0004 50019

Lansing, Michigan, United States

Dv0004 50016

St Louis, Missouri, United States

Dv0004 50005

Freehold, New Jersey, United States

Dv0004 50029

Albuquerque, New Mexico, United States

Dv0004 50010

Brooklyn, New York, United States

...and 37 more locations