A Randomized, Double-Blind, Placebo Controlled, Parallel Group, Single Dose Study of the Safety and Efficacy of Subcutaneously Administered REGN475 in Patients With Osteoarthritis of the Knee
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- The incidence of treatment-emergent adverse events (TEAEs) in patients treated with REGN475 or placebo.
研究概览
简要总结
This is a double-blind, prospective, randomized study in which patients will be randomized to 1 of 5 treatment arms (4 active and 1 placebo).
Each patient will receive one SC injection of REGN475 or placebo and 1 IV infusion of either REGN475 or placebo, on day 1 (baseline) In order to preserve the blind, patients receiving REGN475 SC will also receive placebo IV, and patients receiving REGN475 IV will also receive placebo SC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of OA of the knee according to American College of Rheumatology (ACR) criteria, and experiencing moderate to severe pain in the index knee for at least 3 months prior to the screening visit.
- •Kellgren-Lawrence grade 2-3 radiographic severity of the index knee at or within 6 months prior to Screening.
排除标准
- •Significant concomitant illness including, but not limited to, cardiac, renal, neurological, endocrinological, metabolic or lymphatic disease that would adversely affect the patient's participation in the study.
- •Patients with joint replacement in the affected knee.
- •Intra-articular injection of corticosteroids or hyaluronic acid in the affected knee within the 3 months prior to the screening visit.
- •Women who are pregnant or breast-feeding.
研究组 & 干预措施
Dose 5
SC Placebo and IV Placebo
干预措施: Placebo (Other)
Dose 4
SC Placebo and IV REGN475 Dose 4
干预措施: REGN475 (Biological)
Dose 3
SC REGN475 Dose 3 and IV Placebo
干预措施: REGN475 (Biological)
Dose 2
SC REGN475 Dose 2 and IV Placebo
干预措施: REGN475 (Biological)
Dose 1
SC REGN475 Dose 1 and IV Placebo
干预措施: REGN475 (Biological)
结局指标
主要结局
The incidence of treatment-emergent adverse events (TEAEs) in patients treated with REGN475 or placebo.
时间窗: 16 weeks
次要结局
- Change from baseline in walking knee pain using the Numeric Rating Scale (NRS).(8 weeks)
- Change from baseline in patient-rated QOL using the Short-Form 12-Item Questionnaire (SF-12).(8 weeks)
- Time-integrated change from baseline in The Western Ontario and McMaster Osteoarthritis Index (WOMAC)(8 weeks)
- Change from baseline in The Western Ontario and McMaster Osteoarthritis Index (WOMAC)(8 weeks)
- Time-integrated change from baseline in walking knee pain using the Numeric Rating Scale (NRS).(8 weeks)
- Patient assessment of response to treatment over time using the Patient Global Impression of Change.(16 weeks)