A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate Efficacy and Safety of LNK01001 in Adult Subjects With Active Ankylosing Spondylitis
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 352
- 试验地点
- 1
- 主要终点
- Percentage of Participants Achieving Assessment of SpondyloArthritis International Society 40 (ASAS40) Response at Week 16
研究概览
简要总结
The aim of this study is to evaluate the efficacy and safety of LNK01001 in subjects with active ankylosing spondylitis.
The study is comprised of a 16-week randomized, double-blind, parallel-group, placebo-controlled period (the Double-Blind Period); a 36-week open-label, long-term extension period (the Open-Label Extension Period). In the Double-Blind Period, participants will be randomized in a 1:1 ratio to receive either LNK01001 or placebo twice daily (BID). Participants in the placebo group will be switched to LNK01001 BID at Week 16 in the Open-Label Extension Period.
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
- •Must have a clinical diagnosis of ankylosing spondylitis (AS) and meet the modified New York Criteria for AS.
- •Participant must have a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score ≥ 4 at the Screening and Baseline Visits and Must have a Total Back Pain score ≥ 4 based on a 0 - 10 numerical rating scale at the Screening and Baseline Visits.
- •Has had an inadequate response to at least 2 nonsteroidal anti-inflammatory drugs (NSAIDs) over an at least 4-week period in total at maximum recommended or tolerated doses, or has an intolerance to or contraindication for NSAIDs as defined by the Investigator.
排除标准
- •Total spinal ankylosis.
- •Participants with known allergies to components or excipients of the study drug.
- •Requirement of prohibited medications during the study.
- •Participants who are pregnant, nursing, or planning a pregnancy during the study period.
研究组 & 干预措施
LNK01001 12mg
Participants receive LNK01001 12mg orally BID for 52 weeks.
干预措施: LNK01001 (Drug)
Placebo
Participants receive matching placebo for 16 weeks and then switch to receive LNK01001 12mg orally BID for 36 weeks.
干预措施: LNK01001 (Drug)
Placebo
Participants receive matching placebo for 16 weeks and then switch to receive LNK01001 12mg orally BID for 36 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of Participants Achieving Assessment of SpondyloArthritis International Society 40 (ASAS40) Response at Week 16
时间窗: Baseline and week 16
ASAS40 response was defined as improvement of ≥ 40% relative to Baseline and absolute improvement of ≥ 2 units (on a scale from 0 to 10) in ≥ 3 of the following 4 domains with no deterioration (defined as a net worsening of \> 0 units) in the potential remaining domain: * Patient's global assessment of disease activity, measured on a numeric rating scale (NRS) from 0 (no activity) to 10 (severe activity); * Pain, measured by the total back pain NRS from 0 (no pain) to 10 (most severe pain); * Function, measured by the Bath Ankylosing Spondylitis Functional Index (BASFI) which consists of 10 items assessing participants' ability to perform activities on an NRS ranging from 0 (easy) to 10 (impossible); * Inflammation, measured by the mean of the 2 morning stiffness-related Bath AS Disease Activity Index (BASDAI) NRS scores (items 5 \[level of stiffness\] and 6 \[duration of stiffness\]) each on a scale from 0 (none/0 hours) to 10 (very severe/2 hours or more duration).
次要结局
- Percentage of Participants Achieving Assessment of SpondyloArthritis International Society 20 (ASAS20) Response at Week 16(Baseline and week 16)
- Percentage of Participants With Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Response at Week 16(Baseline and week 16)
- Percentage of Participants With ASDAS Inactive Disease at Week 16(Baseline and week 16)
- Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) at Week 16(Baseline and week 16)
- Change From Baseline in Patient's Assessment of Total Back Pain at Week 16(Baseline and week 16)
- Change From Baseline in Patient's Assessment of Nocturnal Back Pain at Week 16(Baseline and week 16)
- Percentage of Participants With ASDAS Low Disease Activity at Week 16(Baseline and week 16)
- Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 16(Baseline and week 16)
- Change From Baseline in Ankylosing Spondylitis Quality of Life (ASQoL) Score at Week 16(Baseline and week 16)
- Change From Baseline in Linear Bath Ankylosing Spondylitis Metrology Index (BASMI) at Week 16(Baseline and week 16)
- Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) at Week 16(Baseline and week 16)