A Phase 3, Randomized, Double-blind, Placebo- and Active-controlled Study to Evaluate the Efficacy and Safety of TLC599 in Patients With Osteoarthritis of the Knee
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 504
- 试验地点
- 46
- 主要终点
- Change From Baseline in WOMAC Pain at Week 12 for TLC599 12 mg Versus Placebo
研究概览
简要总结
Phase 3 randomized, double-blind, placebo- and active comparator-controlled study of TLC599.
详细描述
This is a Phase 3 randomized, double-blind, placebo- and active comparator-controlled pivotal study. Approximately 500 adult patients with moderate to severe pain due to OA of the knee will be enrolled and randomized. All patients will be followed for a total of 52 weeks. Efficacy and safety of 2 doses of TLC599 will be evaluated in comparison to Placebo and DSP through Week 52.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female ≥40 years of age. BMI ≤ 40 kg/m
- •Radiographically documented OA with Kellgren-Lawrence severity Grade 2 or 3 and associated symptoms Patient-reported pain with NRS score ≥4 (on a 0-10 scale) Able to read, understand, and sign the informed consent form, communicate with the investigator, complete study diaries, and understand and comply with protocol requirements.
排除标准
- •Recent use of IA or systemic corticosteroids Patient who is not ambulatory Any surgery or arthroscopy in the index knee within 12 months Any condition that could possibly confound the patient's assessment of index knee pain Substance abuse disorder, or positive urine drug test for illegal drug substances History of acquired or congenital immunodeficiency diseases History of treated malignancy which is disease free for ≤5 years Known allergy or hypersensitivity to the study drugs or their components
研究组 & 干预措施
TLC599
TLC599 (1mL) IA injection
干预措施: TLC599 (Drug)
Dexamethasone sodium phosphate
DSP 4mg (1mL) IA injection
干预措施: TLC599 (Drug)
Dexamethasone sodium phosphate
DSP 4mg (1mL) IA injection
干预措施: DSP (Drug)
Normal Saline
Normal saline (1mL) IA injection
干预措施: Normal Saline (Other)
结局指标
主要结局
Change From Baseline in WOMAC Pain at Week 12 for TLC599 12 mg Versus Placebo
时间窗: Baseline, Week 12
The WOMAC (Western Ontario \& McMaster Universities Osteoarthritis Index, Version 3.1) consists of 24 questions rated on a 0-4 Likert scale, totaling a score from 0-96, reflecting the previous 24 hours. Sub-scale scores for Pain (5 items, a 0-20 scale), Stiffness (2 items, a 0-8 scale), and Physical Function (17 items, a 0-68 scale) are summed to calculate the WOMAC Composite score. Both composite and sub-scale scores are normalized to a 0-4 scale for analysis, with higher scores indicating greater severity.
次要结局
- Change From Baseline in WOMAC Pain at Week 16 for TLC599 12 mg Versus Placebo(Baseline, Week 16)
- Change From Baseline in WOMAC Pain at Week 20 for TLC599 12 mg Versus Placebo(Baseline, Week 20)
- Change From Baseline in WOMAC Pain at Week 24 for TLC599 12mg Versus Placebo(Baseline, Week 24)
- Change From Baseline in WOMAC Pain at Week 36 for TLC599 12mg Versus Placebo(Baseline, Week 36)
- Change From Baseline in WOMAC Function at Week 12 for TLC599 12mg Versus Placebo(Baseline, Week 12)
- PGIC at Week 12 for TLC599 12mg Versus Placebo(Week 12)
- Total Rescue Acetaminophen Consumption Through Week 12 for TLC599 12mg Versus Placebo(through Week 12)
- Durable Responder With ≥30% Decrease in WOMAC Pain From Baseline for Weeks 4 Through 12 for TLC599 12mg Versus Placebo(Weeks 4 through 12)
- Change From Baseline in WOMAC Function at Week 36 for TLC599 12mg Versus Placebo(Baseline, Week 36)
- PGIC at Week 36 for TLC599 12mg Versus Placebo(Week 36)
- Change From Baseline in WOMAC Pain at Week 12 for TLC599 12mg Versus DSP 4 mg(Baseline, Week 12)
- Change From Baseline in WOMAC Pain at Week 52 for TLC599 12mg Versus Placebo(Baseline, Week 52)