A Randomized, Double-blind, Multi-dose, Placebo-controlled Phase 2/3 Study to Evaluate the Efficacy and Safety of Fasinumab in Patients With Moderate to Severe Chronic Low Back Pain
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 563
- 主要终点
- Change From Baseline to Week 16 in the Average Daily Low Back Pain Index Numeric Rating Scale (LBPI NRS) Score
研究概览
简要总结
The main objective of the trial is to evaluate the efficacy of fasinumab compared to placebo as measured by the change from baseline in the average daily Low Back Pain Intensity (LBPI) Numerical Rating Scale (NRS).
Secondary objectives of the study are to evaluate the efficacy of fasinumab compared to placebo as measured by:
- Change from baseline in the Roland Morris disability questionnaire (RMDQ) total score
- Change from baseline in the Patient Global Assessment (PGA) of Low Back Pain (LBP) score
- Change from baseline in the average daily LBPI NRS score
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
- 35 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female ≥35 years of age at the screening visit
- •Clinical diagnosis of chronic moderate to severe LBP (nonradiculopathic)for ≥3 months
- •History of regular analgesic medication
- •History of inadequate pain relief or intolerance to analgesics used for chronic LBP
- •Willing to discontinue current pain medication
排除标准
- •History of lumbosacral radiculopathy within the past 2 years
- •Evidence on baseline lumbar spine magnetic resonance imaging of potentially confounding conditions
- •Recent use of longer acting pain medications
- •Evidence of destructive arthropathy
- •Other medical conditions that may interfere with participation or accurate assessments during the trial
研究组 & 干预措施
Fasinumab 6 mg SC Q4W and Placebo IV Q8W
Participants randomized to the fasinumab 6 mg SC Q4W arm received fasinumab 12 mg SC on Day 1 (loading dose) and then 6 mg SC (planned maintenance dose) at Weeks 4, 8, and 12 for a total of 4 doses. Matching placebo was received via intravenous (IV) infusion Q8W on Day 1 and at Week 8.
干预措施: Fasinumab (Drug)
Fasinumab 6 mg SC Q4W and Placebo IV Q8W
Participants randomized to the fasinumab 6 mg SC Q4W arm received fasinumab 12 mg SC on Day 1 (loading dose) and then 6 mg SC (planned maintenance dose) at Weeks 4, 8, and 12 for a total of 4 doses. Matching placebo was received via intravenous (IV) infusion Q8W on Day 1 and at Week 8.
干预措施: placebo (Drug)
Fasinumab 9 mg SC Q4W and Placebo IV Q8W
Participants randomized to the fasinumab 9 mg SC Q4W arm received 18 mg SC on day 1 (loading dose) and then 9 mg SC (planned maintenance dose) at weeks 4, 8, and 12 for a total of 4 doses. Matching placebo IV Q8W was received on Day 1 and at Week 8.
干预措施: Fasinumab (Drug)
Fasinumab 9 mg SC Q4W and Placebo IV Q8W
Participants randomized to the fasinumab 9 mg SC Q4W arm received 18 mg SC on day 1 (loading dose) and then 9 mg SC (planned maintenance dose) at weeks 4, 8, and 12 for a total of 4 doses. Matching placebo IV Q8W was received on Day 1 and at Week 8.
干预措施: placebo (Drug)
Fasinumab 9 mg IV Q8W and Placebo SC Q4W
Participants randomized to the fasinumab 9 mg IV Q8W arm received IV infusions of fasinumab 9 mg on Day 1 and Week 8, for a total of 2 doses. Matching placebo SC Q4W was received on day 1 and at weeks 4, 8, and 12.
干预措施: Fasinumab (Drug)
Fasinumab 9 mg IV Q8W and Placebo SC Q4W
Participants randomized to the fasinumab 9 mg IV Q8W arm received IV infusions of fasinumab 9 mg on Day 1 and Week 8, for a total of 2 doses. Matching placebo SC Q4W was received on day 1 and at weeks 4, 8, and 12.
干预措施: placebo (Drug)
Placebo SC Q4W and Placebo IV Q8W
Participants randomized to the matching placebo subcutaneously (SC) every four weeks (Q4W) arm received SC placebo in a manner similar to the SC loading dose of the active groups (placebo loading dose) on Day 1 and then an SC injection of placebo at weeks 4, 8, and 12 for a total of 4 doses. Matching placebo intravenously (IV) every 8 weeks (Q8W) was received on Day 1 and at Week 8.
干预措施: placebo (Drug)
结局指标
主要结局
Change From Baseline to Week 16 in the Average Daily Low Back Pain Index Numeric Rating Scale (LBPI NRS) Score
时间窗: Baseline to Week 16
Average daily low back pain (LBP) was assessed on an 11-point numeric rating scale (NRS) and was defined as the average of the non-missing daily LBPI NRS scores for the 7 days before and including nominal visit. Participants described their average low back pain during the past 24 hours on a scale ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicate higher pain.
次要结局
- Change From Baseline to Week 16 in the Patient Global Assessment (PGA) of Low Back Pain (LBP) Score(Baseline to Week 16)
- Change From Baseline to Weeks 2, 4, 8, and 12 in the Average Low Back Pain Index Numeric Rating Scale Score (LBPI NRS)(Baseline to Weeks 2, 4, 8, and 12)
- Change From Baseline to Week 16 in Roland Morris Disability Questionnaire (RMDQ) Total Score(Baseline to Week 16)