A Multicenter, Randomized, Double-Blind and Placebo-Controlled 16-Week Study Followed by Long Term Evaluation of Efficacy and Safety of Ixekizumab (LY2439821) in Chinese Patients With Radiographic Axial Spondyloarthritis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 147
- 试验地点
- 19
- 主要终点
- Percentage of Participants Achieving an Assessment of Spondyloarthritis International Society 40 (ASAS40) Response in Biological Disease-modifying Antirheumatic Drug (bDMARD)-naïve Participants
研究概览
简要总结
The main purpose of this study is to evaluate the efficacy and safety of ixekizumab in Chinese participants with radiographic axial spondyloarthritis (r-axSpA).
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
- •Have an established diagnosis of radiographic axial spondyloarthritis (r-xSpA) with sacroiliitis defined radiographically according to the modified New York criteria.
- •Participants have a history of back pain ≥3 months with age at onset <45 years.
- •Biologic naïve or have had prior treatment with 1 tumor necrosis factor (TNF) inhibitor.
- •Must have had an inadequate response to 2 or more NSAIDs at the therapeutic dose range for a total duration of at least 4 weeks OR have a history of intolerance to NSAIDs.
- •Have a history of prior therapy for axSpa for at least 12 weeks prior to screening.
排除标准
- •Have total ankylosis of the spine.
- •Have recently received a live vaccine within 12 weeks or have had a vaccination with Bacillus Calmette-Guerin (BCG) within the past year.
- •Have an ongoing or serious infection within the last 12 weeks.
- •Have a compromised immune system.
- •Have any other serious and/or uncontrolled diseases.
- •Have either a current diagnosis or a recent history of malignant disease.
- •Have had major surgery within 8 weeks of baseline, or will require surgery during the study.
- •Are pregnant or breastfeeding.
研究组 & 干预措施
Ixekizumab
Participants received Ixekizumab during the double-blind and extended treatment periods (i.e.,) starting dose of 160 milligrams (mg) Ixekizumab in the beginning week followed by 80 mg Ixekizumab once every four weeks (Q4W) by subcutaneous injection. No treatments were administered during the follow-up period.
干预措施: Ixekizumab (Drug)
Placebo
Participants received placebo every four weeks (Q4W) by subcutaneous (SC) injection during the double-blind period. During the extension period, they received starting dose of 160 milligrams (mg) Ixekizumab in the beginning week followed by 80 mg Ixekizumab once every four weeks (Q4W) by subcutaneous injection. No treatments were administered during follow-up period.
干预措施: Ixekizumab (Drug)
Placebo
Participants received placebo every four weeks (Q4W) by subcutaneous (SC) injection during the double-blind period. During the extension period, they received starting dose of 160 milligrams (mg) Ixekizumab in the beginning week followed by 80 mg Ixekizumab once every four weeks (Q4W) by subcutaneous injection. No treatments were administered during follow-up period.
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of Participants Achieving an Assessment of Spondyloarthritis International Society 40 (ASAS40) Response in Biological Disease-modifying Antirheumatic Drug (bDMARD)-naïve Participants
时间窗: Week 16
ASAS40 is defined as improvement from baseline of greater than or equal to (\>=) 40 % and absolute improvement from baseline of at least 2 units (range of 0 to 10) in at least 3 of the following 4 domains without any worsening in the remaining domain. 1. Patient Global: How active was your spondylitis on average during the last week? score ranges 0 (not active) to 10 (very active). 2. Spinal Pain: How much Pain of your spine due to Ankylosing spondylitis? score ranges 0 (no pain) to 10 (severe pain). 3. Bath Ankylosing Spondylitis Functional Index (BASFI): Participant asked to rate the difficulty associated with 10 individual basic functional activities. Participant response was captured using Numeric Rating Scale (NRS) (range 0 to 10) with a higher score indicating worse function. 4. Inflammation based on Q5 \& Q6 mean of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) (mean of intensity \& duration of stiffness): Score ranges from "0" (none) and "10" (very severe).
次要结局
- Percentage of Participants Achieving an ASAS40 Response(Week 16)
- Percentage of Participants Achieving an ASAS20 Response(Week 16)
- Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)(Baseline, Week 16)
- Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Response(Baseline, Week 16)
- Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI)(Baseline, Week 16)
- Change From Baseline in Magnetic Resonance Imaging (MRI) of the Spine (Spondyloarthritis Research Consortium of Canada [SPARCC] Score)(Baseline, Week 16)
- Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES)(Baseline, Week 16)
- Change From Baseline in ASAS-Nonsteroidal Anti-Inflammatory Drug (NSAID) Score(Baseline, Week 52)
- Change From Baseline in 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) Score(Baseline, Week 16)
- Change From Baseline in 36-Item SF-36 Mental Component Summary (MCS) Score(Baseline, Week 16)
- Change From Baseline in MRI Sacroiliac Joint(s) (SIJ) Spondyloarthritis Research Consortium of Canada (SPARCC) Score(Baseline, Week 16)
- Number of Participants With Anterior Uveitis(Baseline through Week 16)
- Pharmacokinetics (PK): Trough Ixekizumab Concentration at Steady State (Ctrough ss)(Week 16)
- Change From Baseline in the Measure of High Sensitivity C-Reactive Protein (CRP)(Baseline, Week 16)
- Change From Baseline in Mobility on the Bath Ankylosing Spondylitis Metrology Index (BASMI)(Baseline, Week 16)
- Percentage of Participants With Anti-Ixekizumab Antibodies(Week 16)