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 bDMARD-Naive Patients With Radiographic Axial Spondyloarthritis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 341
- 试验地点
- 20
- 主要终点
- Percentage of Participants Achieving an Assessment of Spondyloarthritis International Society 40 (ASAS40) Response
研究概览
简要总结
The main purpose of this study is to evaluate the safety and efficacy of the study drug known as ixekizumab in biological disease-modifying anti-rheumatic drugs (bDMARDs)-naive participants with radiographic axial spondyloarthritis (rad-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
- •Are ambulatory.
- •Diagnosis of radiographic axial spondyloarthritis (rad-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.
- •In the past had an inadequate response to at least 2 non-steroidal anti-inflammatory drugs (for duration 4 weeks) or cannot tolerate NSAIDS.
- •If taking NSAIDS be on a stable dose for at least 2 weeks prior to randomization.
- •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 received any prior, or are currently receiving, treatment with biologics, tumor necrosis factor inhibitors or other immunomodulatory agents.
- •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 or evidence of active tuberculosis.
- •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
Q2W Ixekizumab
Double Blind Period: Starting dose of 80 or 160 milligrams (mg) ixekizumab given subcutaneously (SC) at baseline followed by 80 mg ixekizumab given SC every two weeks (Q2W) to week 14.
Extended Treatment Period: 80 mg ixekizumab given SC Q2W from week 16 to week 52.
干预措施: Ixekizumab (Drug)
Q4W Ixekizumab
Double Blind Period: Starting dose of 80 or 160 mg ixekizumab given SC at baseline followed by 80 mg ixekizumab given SC every four weeks (Q4W) to week 14.
Extended Treatment Period: 80 mg ixekizumab given SC Q4W from week 16 to week 52.
干预措施: Ixekizumab (Drug)
Placebo
Double Blind Period: Placebo given SC Q2W to week 14.
Extended Treatment Period: 80 mg ixekizumab given SC Q2W or Q4W from week 16 to week 52.
干预措施: Ixekizumab (Drug)
Placebo
Double Blind Period: Placebo given SC Q2W to week 14.
Extended Treatment Period: 80 mg ixekizumab given SC Q2W or Q4W from week 16 to week 52.
干预措施: Placebo (Drug)
Adalimumab
Double Blind Period: 40 mg Adalimumab given SC Q2W to week 14.
Extended Treatment Period: 80 mg ixekizumab given SC Q2W or Q4W from week 20 to week 52.
干预措施: Ixekizumab (Drug)
Adalimumab
Double Blind Period: 40 mg Adalimumab given SC Q2W to week 14.
Extended Treatment Period: 80 mg ixekizumab given SC Q2W or Q4W from week 20 to week 52.
干预措施: Adalimumab (Drug)
结局指标
主要结局
Percentage of Participants Achieving an Assessment of Spondyloarthritis International Society 40 (ASAS40) Response
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 in at least 3 of the following 4 domains without any worsening in the remaining domains. 1. Patient Global: How active was your spondylitis on average during the last week? score range 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: Participant is asked to rate the difficulty associated with 10 individual basic functional activities. Participants response is captured using numeric rating scale (NRS) scale (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 ASAS20 Response(Week 16)
- Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)(Baseline, Week 16)
- Percentage of Participants Achieving Bath Ankylosing Spondylitis Disease Activity Index 50 (BASDAI50) Response(Week 16)
- Change From Baseline in Magnetic Resonance Imaging (MRI) of the Spine (Ankylosing Spondylitis Spinal Magnetic Resonance Imaging [ASSpiMRI] - Berlin Score)(Baseline, Week 16)
- Change From Baseline in 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores(Baseline, Week 16)
- Change From Baseline in ASAS Health Index (ASAS HI)(Baseline, 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)
- Change From Baseline in Chest Expansion(Baseline, Week 16)
- Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI)(Baseline, Week 16)
- Percentage of Participants Achieving ASDAS Inactive Disease(Week 16)
- Change From Baseline in Occiput to Wall Distance(Baseline, Week 16)
- Change From Baseline in Severity of Peripheral Arthritis by Tender (TJC)(Baseline, Week 16)
- Change From Baseline in MRI Sacroiliac Joint(s) (SIJ) 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 SPARCC Enthesitis Score(Baseline, Week 16)
- Number of Participants With Anterior Uveitis or Uveitis Flares(Baseline through Week 16)
- Change From Baseline in the Fatigue Numeric Rating Scale (NRS) Score(Baseline, Week 16)
- Change From Baseline in the Jenkins Sleep Evaluation Questionnaire (JSEQ)(Baseline, Week 16)
- Change From Baseline in the Work Productivity Activity Impairment Spondyloarthritis (WPAI-SpA) Scores(Baseline, Week 16)
- Change From Baseline in ASAS-Nonsteroidal Anti-Inflammatory Drug (NSAID) Score(Baseline, Week 52)
- Number of Participants With Anti Ixekizumab Antibodies(Week 16)
- Pharmacokinetics: Trough Ixekizumab Concentration at Steady State (Ctrough ss)(Week 16)
- Change From Baseline in Severity of Peripheral Arthritis by Swollen Joint Count (SJC)(Baseline, Week 16)
- Change From Baseline in Magnetic Resonance Imaging (MRI) of the Spine (Spondyloarthritis Research Consortium of Canada [SPARCC] Score)(Baseline, Week 16)