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
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 214
- 试验地点
- 47
- 主要终点
- 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
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Subjects are not permitted to enroll in DV0004 if any of the PA0012 [NCT04009499] study exclusion criteria are met
研究组 & 干预措施
Bimekizumab-SS
Study participants randomized to this arm will receive assigned bimekizumab dose regimen using the prefilled safety syringe (SS).
干预措施: Bimekizumab (Drug)
Bimekizumab-AI
Study participants randomized to this arm will receive assigned bimekizumab dose regimen using the auto-injector (AI).
干预措施: Bimekizumab (Drug)
结局指标
主要结局
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
时间窗: 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).
次要结局
- 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(Baseline)