A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficiency and Safety of LNK01001 Capsule in Patients With Ankylosing Spondylitis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 177
- 试验地点
- 1
- 主要终点
- Percentage of Participants Achieving 40% Improvement in ASAS Score at Week 12.
研究概览
简要总结
The objective of this study was to evaluate the safety and efficacy of multiple doses of LNK01001 monotherapy versus placebo in the treatment of adults with active Ankylosing Spondylitis
详细描述
This study includes two periods. In Period 1, Participants who meet eligibility criteria will be randomized in a 1:1:1 ratio to receive a twice daily oral LNK01001 Dose A or LNK01001 Dose B or a matching placebo for 12 weeks. Participants who receive a placebo in Period 1 will be re-randomized at Week 13 in a 1:1 ratio to receive a twice daily oral LNK01001 Dose A or LNK01001 Dose B for 12 weeks (period 2). Those participants, based on the ASAS40 response, who receive LNK01001 (Dose A or Dose B) in Period 1 may switch to receive a different treatment dose for 12 weeks (period 2).
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants between ≥ 18 and ≤75 years of age.
- •Diagnosis of ankylosing spondylitis (AS) who meet the 1984 revised New York Criteria for AS.
- •Subjects must have disease activity at Screening and baseline visit.
- •Subjects have received NSAIDs treatment but still have active AS, or subjects have an intolerance to or contraindication for NSAIDs.
- •Never received tumor necrosis factor alpha (TNFα) treatment or prior exposure to ≤1 before randomization.
排除标准
- •History of infection or any active infection.
- •History of malignancy or current diagnosis of malignancy within 5 years before screening visit.
- •Previous recipient of an organ transplant.
- •Diagnosis of active uveitis within 6 months before randomization.
- •Subject with any major surgery (including joint surgery) within 3 months before randomization or planned major surgery within the first 6 months during study.
- •Prior exposure to Janus Kinase (JAK) inhibitor.
- •Subjects who are allergy to any component of the study drug.
研究组 & 干预措施
placebo
Participants were randomized to receive a placebo capsule twice a day (BID) orally for 12 weeks in Period 1. At Week 13 participants were re-randomized to receive LNK01001 capsule dose A or B BID orally for 12 weeks in Period 2.
干预措施: LNK01001 (Drug)
LNK01001 Dose A
Participants were randomized to receive LNK01001 capsule dose A BID orally for 12 weeks in Period 1. At Week 13, participants were re-randomized to LNK01001 dose A or B capsule BID orally for 12 weeks in Period 2.
干预措施: LNK01001 (Drug)
LNK01001 Dose B
Participants were randomized to receive LNK01001 capsule dose B BID orally for 12 weeks in Period 1. At Week 13, participants were re-randomized to LNK01001 capsule dose A or B BID orally for 12 weeks in Period 2.
干预措施: LNK01001 (Drug)
placebo
Participants were randomized to receive a placebo capsule twice a day (BID) orally for 12 weeks in Period 1. At Week 13 participants were re-randomized to receive LNK01001 capsule dose A or B BID orally for 12 weeks in Period 2.
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of Participants Achieving 40% Improvement in ASAS Score at Week 12.
时间窗: Week 12
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 40% Improvement in ASAS Score at Week 8,16,24(Week 8,16,24)
- Percentage of Participants with an ASAS 5/6 response.(Week 8,12,16,24)
- Percentage of Participants Achieving 20% Improvement in ASAS Score.(Week 8,12,16,24)
- Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)(Week 8,12,16,24)
- Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI)(Week 8,12,16,24)
- Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI)(Week 8,12,16,24)
- Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)(Week 8,12,16,24)
- Change From Baseline in Ankylosing Spondylitis Quality of Life (ASQoL) Score(Week 8,12,16,24)