A 5-year, Randomized, Double-blind, Placebo-controlled, Multi-center Study Assessing the Efficacy, Safety, and Tolerability of Intra-articular Regimens of LNA043 Versus Placebo in Patients With Symptomatic Knee Osteoarthritis
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 582
- 试验地点
- 24
- 主要终点
- Change from baseline in the cartilage thickness of the medial compartment of the knee as assessed by imaging.
研究概览
简要总结
The study will determine the optimal dosing regimen of LNA043 in patients with knee osteoarthritis (OA).
详细描述
This study is a 2-period, multicenter, randomized, parallel-group, double-blind, placebo-controlled study consisting of a 2-year Core period, followed by a 3 year extension period. The primary objective of this study is to assess the efficacy of LNA043 compared to placebo at Week 104 as measured by the mean change from baseline in cartilage thickness using qMRI of the target knee
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
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females between 40 and 75 years of age
- •Body mass index (BMI) < 40 kg/m2
- •Diagnosis of primary tibiofemoral knee OA by standard American College of Rheumatology clinical and radiographic criteria
- •and other criteria as specified by the protocol
排除标准
- •Participants with radiographic knee OA K-L grade = 4 on the non-target knee
- •Arthroscopy of the target knee within the 6 months prior to Screening
- •Hemoglobin < 8.5 g/dL (85 g/L) or platelet count < 100,000/μL
- •and other criteria as specified by the protocol
研究组 & 干预措施
LNA043 Dosing Regimen D
LNA043 injection to the knee with dosing regimen D
干预措施: LNA043 Dosing Regimen D (Drug)
LNA043 Dosing Regimen A
LNA043 injection to the knee with dosing regimen A
干预措施: LNA043 Dosing Regimen A (Drug)
LNA043 Dosing Regimen B
LNA04 injection to the knee with dosing regimen B
干预措施: LNA043 Dosing Regimen B (Drug)
LNA043 Dosing Regimen C
LNA043 injection to the knee with dosing regimen C
干预措施: LNA043 Dosing Regimen C (Drug)
Placebo
Injection to the knee
干预措施: Placebo (Drug)
结局指标
主要结局
Change from baseline in the cartilage thickness of the medial compartment of the knee as assessed by imaging.
时间窗: Week 0 to Week 104
To evaluate cartilage thickness changes
次要结局
- Change from baseline in Western Ontario and McMaster Universities Osteoarthritis Index pain scale. The scale (5 questions) ranges from 0 to 50. Higher score indicates a worse outcome.(Week 0 to Week 104)
- Change from baseline in the Osteoarthritis Research Society International physical performance-based assessment of 40-meter (4×10m) fast-paced walk test(Week 0 to Week 104)
- Change from baseline in Western Ontario and McMaster Universities Osteoarthritis Index function scale. The scale (17 questions) ranges from 0 to 170. Higher scores indicates a worse outcome.(Week 0 to Week 104)
- Change from baseline in the cartilage thickness of the knee as assessed by imaging.(Week 0 to Week 104)
- Change from baseline in the Osteoarthritis Research Society International physical performance-based assessments 30-second chair stand test(Week 0 to Week 104)
- Change from baseline in the Osteoarthritis Research Society International physical performance-based assessment of 6-minute walking test(Weeek 0 to Week 104)
- Proportion of participants demonstrating structural progression(Week 0 to Week 104)
- Assessing percentage of participants with adverse events and serious adverse events(Week 0 to Week 104)