NCT05377489已完成3 期
A Single-arm, Open-label, Phase III Trial to Evaluate the Safety and Tolerability of Intra-articular Injections of RTX-GRT7039 in Subjects With Moderate to Severe Pain Associated With Osteoarthritis of the Knee.
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 714
- 试验地点
- 178
- 主要终点
- Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
研究概览
简要总结
An open-label, single-arm clinical trial to confirm the safety of monoarticular injections or bi-lateral intra-articular injections of RTX-GRT7039 in patients who have pain associated with osteoarthritis of the knee despite standard of care.
详细描述
This trial comprises a total observation period of up to 78 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •The participant has given written informed consent to participate.
- •The participant is 18 years of age or older at the Screening Visit.
- •The participant has a diagnosis of osteoarthritis of the knee based on American College of Rheumatology criteria and functional capacity class of I to III.
- •There is a documented history indicating that participant has insufficient pain relief with previous Standard of Care.
排除标准
- •The participant has past joint replacement surgery of the index knee.
- •The participant has a history of significant trauma or surgery (e.g., open or arthroscopic) to the index knee within 12 months of Screening.
- •The participant has periarticular pain at the index knee from any cause other than osteoarthritis, including referred pain, bursitis, tendonitis.
- •The participant has clinical hip osteoarthritis on the side of the index knee.
- •The participant has a history of osteonecrosis, subchondral insufficiency fracture, atrophic osteoarthritis, rapidly progressing osteoarthritis (RPOA) Type I or Type II,pathologic fracture, primary or metastatic tumor, or joint infection in the index knee.
- •The participant has significant malalignment of anatomical axis (medial angle formed by the femur and tibia) of the target knee (varus >10°, valgus >10°) by radiograph as assessed by independent Central Readers at Screening Visit.
- •The participant has other conditions that could affect trial endpoint assessments of the index knee.
- •The participant has current clinically significant disease(s) or condition(s) that may affect safety assessments, or any other reason which may preclude the participant's participation for the full duration of the trial.
- •The participant has a history of hypersensitivity to resiniferatoxin (RTX) or any similar component (capsaicin, chili peppers).
- •The participant is currently participating or was participating in another investigational drug trial within 3 months prior to the Screening Visit.
- •The participant is an employee of the investigator or trial site, with direct involvement in the proposed trial or other trials under the direction of that investigator or trial site or is a family member of the employees or the investigator.
- •The non-index knee is not eligible for treatment in the trial, if any of the knee-related exclusion criteria applies to the non-index knee.
研究组 & 干预措施
RTX-GRT7039
Experimental
Participants will receive injections of RTX-GRT7039 into either the index knee (affected knee or in case of bilateral OA the knee with highest pain intensity), or each of both knees up to Week 52.
干预措施: RTX-GRT7039 (Drug)
结局指标
主要结局
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
时间窗: From Baseline up to Week 78
Number of Participants With TEAEs Leading to Study Discontinuation
时间窗: From Baseline up to Week 78
次要结局
- Number of Participants With TEAEs Representing Structural Changes as Assessed by Imaging Methods(From Baseline up to Week 78)
- Change From Baseline in WOMAC Pain Subscale Score(From Baseline up to Week 12)
研究者
研究点 (178)
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