A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 2b Trial to Evaluate the Efficacy and Safety of YH14618 in Patients With Lumbar Degenerative Disc Disease
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 326
- 试验地点
- 1
- 主要终点
- Proportion of VAS responders
研究概览
简要总结
Research Hypothesis:
There will be a greater proportion of VAS responders defined as those who achieve ≥ 50% reduction from baseline in VAS for low back pain at week 12 following intradiscal injection of YH14618 compared to placebo. Patients have been diagnosed as one or two symptomatic lumbar degenerative disc disease defined as Pfirrmann grade 2 to 4 using MRI. Patients have suffered from persistent low back pain with at least 3 months of conservative therapy and must have low back pain measured by VAS≥4 cm and modified Oswestry disability index (mODI) ≥30% at the baseline.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed as one or two symptomatic early lumbar (L1/L2 ~ L5/S1) degenerative disc disease defined as Pfirrmann grade 2 to 4 using MRI performed within 4 weeks prior to randomization.
- •Patients have suffered from persistent low back pain with at least 3-month conservative therapy.
- •Patients have low back pain measured by VAS≥4cm and mODI≥30% at screening and randomization visit (Day 0).
排除标准
- •Clinically significant spine compression fracture, spinal stenosis, or spinal instability.
- •Clinically significant sacroiliac joint dysfunction, facet joint pain, or those who are suspected.
- •Modic change type III assessed by X-ray and MRI
- •History of spine surgery
- •Neurologic disorders.
- •Any other systemic disease which can influence spine such as rheumatoid arthritis, ankylosing spondylitis, or autoimmune disease.
- •Participation in other clinical trials with intradiscal injection (eg, Phase 1/2a YH14618-201 trial, or Cell therapy, etc.)
研究组 & 干预措施
Group B
YH14618 B mg/disc
干预措施: YH14618 (Drug)
Placebo group
Placebo
干预措施: Placebo (Drug)
Group A
YH14618 A mg/disc
干预措施: YH14618 (Drug)
Group C
YH14618 C mg/disc
干预措施: YH14618 (Drug)
Group D
YH14618 D mg/disc
干预措施: YH14618 (Drug)
结局指标
主要结局
Proportion of VAS responders
时间窗: at 12-week
Proportion of VAS responders defined as those who achieve ≥ 50% reduction in VAS at week 12 from baseline
次要结局
- Proportion of VAS responders(at 24-week)
- Proportion of mODI responder(at 12-week, 24-week)
- Changes in VAS score from baseline(Each visit for 24 weeks)
- Changes in mODI score from baseline(Each visit for 24 weeks)