An Open-label, Randomized, Parallel-group, Noninferiority Study to Evaluate the Pharmacokinetics of Bimekizumab Administered Intravenously or as a Subcutaneous Injection in Participants With Active Psoriatic Arthritis and/or Active Axial Spondyloarthritis
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 392
- 试验地点
- 65
- 主要终点
- Steady-state Trough Concentration (Ctrough,ss) at Week 16
研究概览
简要总结
To demonstrate that bimekizumab administered intravenously is noninferior to subcutaneous administration.
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
- •Be 18+ years old and legally able to consent
- •Have active psoriatic arthritis (PsA) or axial spondyloarthritis (axSpA), suitable for bimekizumab treatment
- •Weigh between 45-100 kg (females) or 50-100 kg (males).
- •Be biologic disease-modifying anti-rheumatic drug (bDMARD)-naïve or have stopped bDMARDs ≥3 months or 5 half-lives ago
排除标准
- •Serious organ system disorders (e.g., heart, liver, kidney, gastrointestinal, neuro)
- •Severe psychiatric issues or substance abuse in the past year
- •Recent or chronic infections, including tuberculosis (TB) or nontuberculous mycobacterium (NTMB)
- •Other inflammatory diseases (e.g., rheumatoid arthritis (RA), lupus, inflammatory bowel disease (IBD))
- •Recent live vaccines (within 8 weeks) or Bacillus Calmette-Guerin (BCG) (within 1 year)
- •Recent use of glucagon-like peptide-1 (GLP-1) agonists (within 28 weeks)
研究组 & 干预措施
Bimekizumab arm 2
Subjects participating in the study will receive assigned bimekizumab dosing regimen 3 during the PK Lead-In Phase and dosing regimen 3 during Treatment Period.
干预措施: Bimekizumab regimen 3 sc (Drug)
Bimekizumab arm 1
Subjects participating in the study will receive assigned bimekizumab dosing regimen 1 or 2 during the PK Lead-In Phase and dosing regimen 1 or 2 during Treatment Period.
干预措施: Bimekizumab regimen 1 iv (Drug)
Bimekizumab arm 1
Subjects participating in the study will receive assigned bimekizumab dosing regimen 1 or 2 during the PK Lead-In Phase and dosing regimen 1 or 2 during Treatment Period.
干预措施: Bimekizumab regimen 2 iv (Drug)
结局指标
主要结局
Steady-state Trough Concentration (Ctrough,ss) at Week 16
时间窗: Week 16
Steady-state trough concentration (Ctrough,ss) will be reported.
次要结局
- Occurrence of treatment-emergent Adverse Events (TEAEs) from Baseline to the end of Safety Follow-Up (SFU) Visit(From Baseline to the end of SFU Visit (up to Week 29))
- Occurrence of treatment-emergent Serious Adverse Events (SAEs) from Baseline to the end of SFU Visit(From Baseline to the end of SFU Visit (up to Week 29))
- Occurrence of TEAEs leading to withdrawal of study intervention(From Baseline to the end of SFU Visit (up to Week 29))