NCT01870284撤回3 期
A Multicenter, Randomized, Double-Blind, Active and Placebo-Controlled 16-Week Study Followed by Long Term Evaluation of Efficacy and Safety of Ixekizumab (LY2439821) in Patients With Active Ankylosing Spondylitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Efficacy of Ixekizumab in Participants with Ankylosing Spondylitis (AS). Measure: Assessment of SpondyloArthritis International Society Criteria (ASAS20)
研究概览
简要总结
This study will assess the safety and efficacy of ixekizumab (LY2439821) compared to placebo in participants with active AS.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Diagnosis of moderate to severe AS with prior documented radiologic evidence (X-ray) fulfilling the Modified New York criteria for AS (1984)
- •Have active AS defined as Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) ≥4 and the spinal pain (back pain) score ≥4 on a numeric rating scale (NRS)
- •Participants should have been on nonsteroidal anti-inflammatory drugs (NSAIDs) with an inadequate response
- •Participants who are regularly taking NSAIDs or cyclooxygenase-2 (COX-2) inhibitors as part of their AS therapy are required to be on a stable dose
- •Participants who have been on a tumor necrosis factor alpha (TNF) inhibitor (not more than one) must have experienced an inadequate response
- •Total duration of prior therapy (NSAIDs and/or adequate physical therapy) should be at least 12 weeks
- •Men must agree to use a reliable method of birth control or remain abstinent during the study
- •Women must agree to use reliable birth control or remain abstinent during the study and for at least 12 weeks after stopping treatment
排除标准
- •Participants with a total ankylosis of the spine
- •Prior or current treatment with adalimumab
- •Participants previously treated with any biological or other immunomodulating agents except for those targeting TNF
- •Evidence of active inflammatory arthritic syndromes or spondyloarthropathies other than ankylosing spondylitis
- •Have participated in any study with interleukin 17 (IL-17) antagonists, including ixekizumab
- •Serious disorder or illness other than ankylosing spondylitis
- •Serious infection within the last 3 months
- •Breastfeeding or nursing (lactating) women
研究组 & 干预措施
Ixekizumab Dosing Regimen 1
Experimental
Administered by 80 milligram (mg) subcutaneous (SC) injection
干预措施: Ixekizumab (Drug)
Ixekizumab Dosing Regimen 2
Experimental
Administered by 80 mg SC Injection
干预措施: Ixekizumab (Drug)
Placebo
Placebo Comparator
Placebo for ixekizumab and placebo for adalimumab administered by SC injection
干预措施: Placebo (Drug)
Adalimumab
Active Comparator
Administered by 40 mg SC injection
干预措施: Adalimumab (Drug)
结局指标
主要结局
Efficacy of Ixekizumab in Participants with Ankylosing Spondylitis (AS). Measure: Assessment of SpondyloArthritis International Society Criteria (ASAS20)
时间窗: 16 Weeks
次要结局
- Efficacy of Ixekizumab in Participants with AS. Measure: ASAS(16 Weeks)
- Efficacy of Ixekizumab in Participants with AS. Measure: Peripheral Joint Counts(16 Weeks)
- Quality of Life and Outcome Assessments. Measures: Patient Reported Outcomes (PRO)(Baseline through 16 Weeks)
- Efficacy of Ixekizumab in Participants with AS. Measure: Spinal Mobility(Baseline through 16 Weeks)
- Efficacy of Ixekizumab in Participants with AS. Measure: modified Stoke Ankylosing Spondylitis Spinal Score (mSASSS)(Baseline through 108 Weeks)
- Efficacy of Ixekizumab in Participants with AS. Measure: Non-Arthritic Disease Assessments(Baseline through 16 Weeks)
研究者
研究点 (1)
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