NCT02985983已完成3 期
A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled Study With an Open Label Extension to Evaluate the Efficacy and Safety of Brodalumab in Subjects With Axial Spondyloarthritis
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 159
- 试验地点
- 48
- 主要终点
- Percentage of ASAS 40 in axSpA subjects
研究概览
简要总结
To evaluate the efficacy of Brodalumab in axSpA (ankylosing spondylitis [AS] and non-radiographic axial spondyloarthritis [nr-axSpA]) subjects compared to placebo, as measured by the proportion of axSpA subjects achieving an Assessment of SpondyloArthritis international Society (ASAS) 40 response at week 16.
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
- Double (Participant, Investigator)
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 with age at onset <45 years and continuous chronic back pain for ≥ 3 months fulfills the ASAS classification criteria of axial spondyloarthritis (with the exception of the Crohn's disease)
- •Subject has Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score ≥ 4 at screening and enrollment
- •Subject has spinal pain score (BASDAI question #2) ≥ 4 at screening and enrollment
- •Subject has had adequate therapy with non-steroidal anti-inflammatory drugs (oral NSAIDs) for back pain for at least 3 months with inadequate treatment response before enrollment
排除标准
- •Complete ankylosis (fusion) of the spine
- •Subject with active ongoing inflammatory diseases other than axSpA that might confound the evaluation of Brodalumab therapy, including reactive arthritis, spondyloarthritis associated with inflammatory bowel disease, SAPHO syndrome (pustulotic arthro-osteitis), fibromyalgia, ankylosing spinal hyperostosis, osteitis condensans ilii, spondylosis deformans, or osteoarthritis sacroiliac joint disease
- •Subject has a prior history of >1 anti-tumor necrosis factor (TNF) therapy
- •Subject has a history or evidence of suicidal ideation (severity of 4 or 5) or any suicidal behavior based on an assessment with the Columbia-Suicide Severity Rating Scale (C-SSRS) at enrollment
- •Subject has a history or evidence of a psychiatric disorder, alcohol and/or substance abuse
- •Subject has severe depression based on a total score of ≥ 15 on the Patient Health Questionnaire-8 (PHQ-8) at enrollment (note: subjects with a total score of 10 to 14 on the PHQ-8 should be referred to a mental health care professional)
研究组 & 干预措施
Brodalumab
Experimental
Brodalumab administered SC
干预措施: Brodalumab (Drug)
Placebo
Placebo Comparator
Placebo administered SC
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of ASAS 40 in axSpA subjects
时间窗: Week 16
次要结局
- Percentage of ASAS 40 in nr-axSpA subjects(Week 16)
- Number of patients exposed to anti-KHK4827 antibodies(Pre-dose,Week 16,Week 32,Week 48,Week 68 or End of study)
- Number of adverse events(Up to week 68)
- Percentage of ASAS 40 in AS subjects(Week 16)
- Ankylosing Spondylitis Disease Activity Score (ASDAS)-CRP change from baseline in axSpA subjects(Week 16)
- Serum KHK4827 concentration(pre-dose、Week 1、Week 2、Week 4、Week 8、Week 12、Week 14、Week 16、Week 24、Week 28、Week 32)
研究者
研究点 (48)
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