NCT03956550终止2 期
A Randomized, Double-Blind, Multi-Dose, Placebo-Controlled Study to Evaluate the Efficacy and Safety of REGN5069 in Patients With Pain Due to Osteoarthritis of the Knee
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 259
- 试验地点
- 1
- 主要终点
- Change From Baseline to Week 12 in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score
研究概览
简要总结
The primary objective of the study is to evaluate the efficacy of REGN5069 compared to placebo in patients with pain due to radiographically-confirmed OA of the knee who have a history of inadequate joint pain relief or intolerance to current analgesic therapy.
The secondary objectives of the study are:
- To characterize the concentrations of functional REGN5069 in serum over time when patients are treated for up to 12 weeks
- To assess the safety and tolerability of REGN5069 compared with placebo when patients are treated for up to 12 weeks
- To measure levels of anti-drug antibodies (ADAs) against REGN5069 following multiple IV administrations
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
- •Generally in good health at the screening visit
- •Body mass index (BMI) ≤39 kg/m2 at the screening visit
- •Clinical diagnosis of OA of the knee on the American College of Rheumatology criteria (Altman, 1986) with radiologic evidence of OA (K-L score ≥2) at the index joint at the screening visit
- •Moderate-to-severe pain in the index joint
- •A history of inadequate pain relief from or intolerance to analgesics used for OA
排除标准
- •Diagnosis of systemic diseases that may affect joints
- •History or presence of osteonecrosis, destructive arthropathy, neuropathic joint arthropathy, pathologic fractures in any shoulder, hip, or knee joint(s), hip dislocation (prosthetic hip dislocation is eligible), or knee dislocation (patella dislocation is eligible) at the screening visit. Presence of subchondral insufficiency fracture on screening films or MRI as assessed by the central imaging reader.
- •Is scheduled for a joint replacement surgery to be performed during the study period
- •Received an intra-articular injection of hyaluronic acid in any joint within 90 days prior to the screening visit
- •Systemic (ie, IV, oral, or intramuscular) corticosteroids within 30 days prior to the screening visit. Intra-articular corticosteroids in the index joint within 12 weeks prior to the screening visit, or to any other joint within 30 days prior to the screening visit (topical, intranasal, or inhaled corticosteroids are permitted).
- •History or presence at the screening visit of multiple sclerosis, autonomic neuropathy, diabetic neuropathy, or other peripheral neuropathy
- •Significant concomitant illness including, but not limited to, psychiatric, cardiac, renal, hepatic, neurological, endocrinological, metabolic, or lymphatic disease that, in the opinion of the investigator, would adversely affect the patient's participation in the study
- •History of myocardial infarction, acute coronary syndromes, transient ischemic attack, or cerebrovascular accident within 12 months prior to the screening visit
- •Note: Other protocol defined inclusion/exclusion criteria apply.
研究组 & 干预措施
REGN5069 Low Dose
Experimental
Randomized in a 1:1:1 ratio
干预措施: REGN5069 (Drug)
REGN5069 High Dose
Experimental
Randomized in a 1:1:1 ratio
干预措施: REGN5069 (Drug)
Matching Placebo
Experimental
Randomized in a 1:1:1 ratio
干预措施: Matching Placebo (Drug)
结局指标
主要结局
Change From Baseline to Week 12 in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score
时间窗: Baseline to Week 12
The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.
次要结局
- Number of Imaging Abnormalities Consistent With Adjudicated Arthropathies Through End of Study(Baseline to Week 36)
- Change From Baseline to Week 12 in WOMAC Total Score(Week 12)
- Change From Baseline to Week 12 in Patient Global Assessment (PGA) Score(Week 12)
- Change From Baseline to Week 12 in WOMAC Physical Function Subscale Score(Week 12)
- Change From Baseline to Week 12 in WOMAC Stiffness Subscale Score(Week 12)
- Percentage of Participants With ≥30% Improvement in WOMAC Pain Subscale Score(Week 12)
- Number of Non-Serious and Serious Treatment-Emergent Adverse Events (TEAEs) Through End of Study(Baseline to Week 36)
- Number of Participants With Presence of Anti-REGN5049 Antibody Development Through End of Study(Baseline to Week 36)
研究者
研究点 (1)
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