A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Fasinumab in Patients With Moderate-to-Severe Chronic Low Back Pain and Osteoarthritis of the Hip or Knee
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 63
- 试验地点
- 3
- 主要终点
- Change From Baseline to Week 16 in the Average Daily Low Back Pain Intensity (LBPI) Numeric Rating Scale (NRS) Score
研究概览
简要总结
The primary objective of the study is to evaluate the efficacy of fasinumab in relieving Chronic low back pain (CLBP) as compared to placebo in participants with a clinical diagnosis of moderate-to-severe non-radicular CLBP and Osteoarthritis (OA) of the knee or hip when treated for up to 16 weeks. The secondary objectives of the study are: To evaluate the safety and tolerability of fasinumab compared to placebo when participants with a clinical diagnosis of moderate-to-severe non-radicular CLBP and OA of the knee or hip are treated for up to 16 weeks; To characterize the concentrations of fasinumab in serum over time when participants with a clinical diagnosis of moderate-to-severe non-radicular CLBP and OA of the knee or hip are treated for up to 16 weeks; To evaluate the immunogenicity of fasinumab when treated for up to 16 weeks in participants with a clinical diagnosis of moderate-to-severe non-radicular CLBP and OA of the knee or hip.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of non-radicular moderate-to-severe CLBP for ≥3 months (prior to screening visit)
- •Clinical diagnosis of OA in at least 1 hip or knee joint based on the American College of Rheumatology Criteria with radiographic evidence of OA (K-L ≥2) at screening
- •History of inadequate relief of CLBP from non-pharmacologic therapy
- •Willing to undergo joint replacement (JR) surgery, if necessary
- •History of regular analgesic medication use
- •History of inadequate pain relief or intolerance to analgesics used for chronic LBP
排除标准
- •Patient is not a candidate for MRI
- •History of major trauma or back surgery in the past 6 months prior to the screening visit
- •History or presence of pyriformis syndrome
- •Evidence on baseline lumbar spine magnetic resonance imaging of potentially confounding conditions
- •History or evidence on joint imaging of conditions that may confound joint safety evaluation
- •Evidence or symptoms consistent with autonomic dysfunction (e.g., orthostatic hypotension and/or autonomic symptoms) as defined in the protocol
- •Recent use of longer acting pain medications
- •Other medical conditions that may interfere with participation or accurate assessments during the trial
- •Note: Other protocol defined Inclusion/ Exclusion criteria apply.
研究组 & 干预措施
Fasinumab
Subcutaneous (SC) every 4 weeks (Q4W)
干预措施: Fasinumab (Drug)
Placebo
SC every 4 weeks
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 Intensity (LBPI) Numeric Rating Scale (NRS) Score
时间窗: Week 1, Week 2, Week 4, Week 8, Week 12, 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 Roland Morris Disability Questionnaire (RMDQ) Total Score(Week 2, Week 4, Week 8, Week 12, Week 16)
- Change From Baseline to Week 16 in Patient Global Assessment (PGA) of Low Back Pain (LBP) Score(Week 2, Week 4, Week 8, Week 12, Week 16)
- Number of Adjudicated Arthropathy (AA) Events(Up to Week 36)
- Number of Sympathetic Nervous System (SNS) Dysfunction Events(Up to Week 36)
- Number of Participants Achieving ≥30% Reduction From Baseline to Week 16 in Average Daily LBPI NRS Score(Week 16)
- Change From Baseline to Week 16 in the Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Score(Week 2, Week 4, Week 8, Week 12, Week 16)
- Number of Adjudicated Arthropathy (AA) Events Meeting Destructive Arthropathy (DA) Criteria(Up to Week 36)
- Number of Treatment-Emergent Adverse Events (TEAEs)(Up to Week 16)
- Number of All-Cause Joint Replacement (JR) Surgery Events(Up to Week 36)
- Number of Joint Replacement (JR) Surgery Events Reported at Telephone Survey After Last Dose of Study Drug(Up to Week 64)
- Serum Concentration of Functional Fasinumab Over Time(Baseline, Week 2, Week 4, Week 8, Week 16)
- Number of Peripheral Sensory Adverse Events (AEs) That Require a Neurology Consultation(Up to Week 36)
- Number of Participants With at Least One Positive Anti-Drug Antibody (ADA) Assay(16 Weeks)