A Multicenter Study of Secukinumab, With a Randomized Double-blind, Placebo-controlled Withdrawal-retreatment Period, to Evaluate Maintenance of Response in Participants With Non-radiographic Axial Spondyloarthritis Who Achieved Remission
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 240
- 试验地点
- 62
- 主要终点
- The proportion of participants remaining flare-free during Treatment Period 2
研究概览
简要总结
This study will establish whether prolonged chronic dosing with secukinumab is needed in participants with Non-radiographic axial spondyloarthritis, (nr-axSpA) who have achieved remission. Remission is defined as Ankylosing Spondylitis Disease Activity Score - C-reactive protein (ASDAS-CRP) Inactive Disease (ID) response (ASDAS-CRP < 1.3). Maintenance of remission on continued secukinumab treatment will be evaluated compared to placebo using a randomized withdrawal design. The primary outcome measure for this study is the proportion of participants remaining flare-free at Week 120.
详细描述
This study will establish whether prolonged chronic dosing with secukinumab is needed in participants with nr-axSpA who have achieved remission. Remission is defined as Ankylosing Spondylitis Disease Activity Score - C-reactive protein (ASDAS-CRP) Inactive Disease (ID) response Inactive Disease (ID) response (ASDAS-CRP < 1.3). The maintenance of remission on continued secukinumab treatment will be evaluated compared to placebo using a randomized withdrawal design. The primary outcome measure for this study is the proportion of participants remaining flare-free at Week 120.
Study treatment will be as follows:
- Open-label Secukinumab PFS (prefilled syringe) will be labeled as AIN457 150mg/1mL
- Double-blind Secukinumab and Placebo PFS will be labeled as AIN457 150mg/1mL/Placebo.
Study duration will be up to 128 weeks from Baseline.
The treatment duration will be up to 120 weeks with last treatment administration at Week 116.
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or non-pregnant, non-lactating female participants at least 18 years of age
- •Clinical diagnosis of axSpA AND according to ASAS axSpA criteria:
- •Inflammatory back pain for at least 6 months
- •Onset before 45 years of age
- •Sacroiliitis on MRI (magnetic resonance imaging) (as assessed by central reader) with ≥ 1 SpA feature OR HLA-B-27 positive with ≥2 SpA features
- •Objective signs of inflammation at screening, evident by either MRI with Sacroiliac Joint inflammation (as assessed by central reader) AND / OR hsCRP > ULN (as defined by the central lab)
- •Active axSpA as assessed by total BASDAI ≥ 4 cm (0-10 cm) at baseline.
- •Spinal pain as measured by BASDAI question #2 ≥ 4 cm (0-10 cm) at baseline.
- •Total back pain as measured by VAS (visual analog scale) ≥ 40 mm (0-100 mm) at baseline.
- •Participants should have been on at least 2 different NSAIDs (non-steroidal anti-inflammatory drugs) at the highest recommended dose for at least 4 weeks in total prior to baseline with an inadequate response or failure to respond, or less if therapy had to be withdrawn due to intolerance, toxicity or contraindications.
排除标准
- •Participants with radiographic evidence for sacroiliitis, grade ≥ 2 bilaterally or grade ≥ 3 unilaterally (radiological criterion according to the modified New York diagnostic criteria for AS) as assessed by central reader.
- •Participants taking high potency opioid analgesics (e.g., methadone, hydromorphone, morphine).
- •Previous exposure to secukinumab or any other biologic drug directly targeting IL-17 or IL-17 receptor or previous treatment with immunomodulatory biologic agents including those targeting TNFα (tumor necrosis factor α) (unless participants discontinued the treatment with TNFα inhibitor due to a reason other than efficacy [primary or secondary lack of efficacy, inadequate response] and only after appropriate wash-out period prior to baseline was observed).
- •History of hypersensitivity to the study drug or its excipients or to drugs of similar chemical classes.
- •Active ongoing inflammatory diseases other than nr-axSpA that might confound the evaluation of the benefit of secukinumab therapy, including uveitis.
- •Active inflammatory bowel disease.
- •History of ongoing, chronic or recurrent infectious disease or evidence of tuberculosis infection.
研究组 & 干预措施
Treatment Period 2
Double-blind Secukinumab and Placebo PFS labeled as AIN457 150mg/1mL/Placebo
干预措施: Placebo (Drug)
Treatment Period 1
Open-label Secukinumab PFS (prefilled syringe) labeled as AIN457 150mg/1mL
干预措施: Secukinumab (Drug)
Treatment Period 2
Double-blind Secukinumab and Placebo PFS labeled as AIN457 150mg/1mL/Placebo
干预措施: Secukinumab (Drug)
结局指标
主要结局
The proportion of participants remaining flare-free during Treatment Period 2
时间窗: Week 120
The primary efficacy endpoint is the proportion of participants in the randomized withdrawal population remaining flare-free at Week 120. A flare is defined as ASDAS-CRP ≥ 2.1 at 2 consecutive visits, or ASDAS-CRP \> 3.5 at any visit during Treatment Period 2, starting at Week 60. Parameters used for ASDAS-CRP include: * Spinal pain (BASDAI question 2), * Patient's global assessment of disease activity, * Peripheral pain/swelling (BASDAI question 3), * Duration of morning stiffness (BASDAI question 6) * C-reactive protein (CRP) in mg/L
次要结局
- Time to flare during Treatment Period 2(From Week 56 to Week 120)
- Number of participants with Adverse Events(From Baseline to Week 128)
- Time to flare during Treatment Period 2(From Week 56 to Week 120)
- Number of participants with Adverse Events(From Baseline to Week 128)