NCT04506463已完成2 期
A Phase IIb, Randomized, Double-Blind, Placebo-Controlled, Single-administration, Multiple-Dose Study to Demonstrate the Efficacy and Safety of MM-II for Treatment of Knee Pain in Subjects With Symptomatic Knee Osteoarthritis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 397
- 试验地点
- 25
- 主要终点
- Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) A Pain Score
研究概览
简要总结
This is a phase IIb, randomized, double-blind, placebo-controlled study to determine the efficacy and safety of MM-II in subjects with symptomatic knee OA as compared to matching placebo.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is able to provide written consent, understand study requirements, is prepared to complete study procedures and is able to independently communicate meaningfully with study personnel
- •Presence of index knee pain for at least 6 months prior to Screening
- •Men or women ≥ 40 years of age at the time of Screening
- •Radiographic evidence of knee Osteoarthritis
排除标准
- •Pain in the contralateral knee with a severity of ≥ 30 mm on a 100 mm VAS
- •Presence of ≥ 40 mm on a 100 mm VAS pain in any other joints
- •Concomitant moderate or large size synovial fluid effusion of the index knee at Screening .
- •Known diagnosis of infection in the index knee in the past five years prior to Screening
研究组 & 干预措施
Arm A
Experimental
MM-II 1 ml
干预措施: MM-II dose I (Drug)
Arm B
Experimental
MM-II 3 ml
干预措施: MM-II dose II (Drug)
Arm C
Experimental
MM-II 6 ml
干预措施: MM-II dose III (Drug)
Arm 4
Placebo Comparator
Placebo 1ml
干预措施: Placebo (Drug)
Arm 5
Placebo Comparator
Placebo 3ml
干预措施: Placebo (Drug)
Arm 6
Placebo Comparator
Placebo 6ml
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) A Pain Score
时间窗: Week 12
The pain score is based on a score of 0 to 4; the higher the score, the higher the amount of pain.
次要结局
- Change From Baseline in Weekly Average of Daily Knee Pain Scores by VAS(Week 26)
- Change From Baseline in Weekly Average of Daily Global Pain Scores by VAS(Week 26)
研究者
研究点 (25)
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相关资讯
FDA Grants Fast Track Designation to MM-II for Osteoarthritis Knee Pain- The FDA has granted Fast Track designation to MM-II, a non-opioid liposomal suspension, for treating osteoarthritis (OA) knee pain, potentially expediting its development and review.
- Phase 2b trial data showed a single intra-articular injection of MM-II provided significant pain relief compared to placebo for up to 26 weeks in OA patients.
- The Fast Track designation highlights the potential of MM-II to address the unmet need for effective and durable treatments for osteoarthritis, a prevalent degenerative joint disease.
- MM-II demonstrated a greater than 50% improvement in knee pain from weeks 12 to 26, supporting its potential for accelerated regulatory approval.2 years agoSun Pharma and Moebius Medical's MM-II Receives FDA Fast Track Designation for Osteoarthritis Knee Pain- The FDA granted Fast Track Designation to MM-II for osteoarthritis knee pain, expediting its development and review process.
- MM-II is a non-opioid product using liposomes to reduce joint friction, offering a novel approach to pain relief.
- Phase 2b data showed a single MM-II injection provided greater pain relief than placebo for up to 26 weeks.
- Sun Pharma and Moebius Medical are advancing MM-II to Phase 3 trials and seeking CE Mark for EU market entry.2 years ago