A Phase 2, Multi-Centre, Randomised, Double-Blind, Sham Controlled Proof of Concept Trial Evaluating the Efficacy and Safety of TenoMiR by Injection in Subjects With Lateral Epicondylitis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 123
- 试验地点
- 5
- 主要终点
- Numeric Rating Scale (NRS) pain score. Minimum score 0 (no pain), Maximum score 10 (worst possible pain)
研究概览
简要总结
This study is testing a drug called TenoMiR that is being developed for the treatment of tennis elbow (lateral epicondylitis). The study drug is a new compound that works by improving the quality of the collagen which helps repair damage to the elbow. The study drug is being developed in the hope of providing a more reliable treatment than those currently available and can be given at the time of first diagnosis, so that recovery can begin as soon as possible. The study drug has been tested in humans in an earlier study, and appeared to be safe and well-tolerated. This study aims to test the study drug in a larger number of participants.
详细描述
TenoMiR a chemically synthesised mimic of microRNA-29a (miR29a) which has improved stability, activity and cellular uptake while being non-immunogenic, has been created to restore miR29a levels back to pre-injury levels. TenoMiR is unique in directly targeting the key changes in collagen production associated with tendinopathy. Unlike other therapies, TenoMiR has a well-defined mode-of-action that is supported by a wealth of scientific data.
Moreover, treatment with TenoMiR does not require invasive biopsies and can be delivered at the point of initial diagnosis initiating recovery at the very earliest time. This is a global multicentre study which will test TenoMiR in a larger population, to follow on from the previous Phase 1b study in which TenoMiR appeared to be both safe and well-tolerated.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must meet all of the following inclusion criteria.
- •Subject has a clinical diagnosis of lateral epicondylitis.
- •Aside from lateral epicondylitis, the subject is otherwise healthy as determined by a responsible physician, based on medical history, physical examinations, concomitant medication, vital signs, 12-lead ECGs and clinical laboratory evaluations. Laboratory values may be retested once at the discretion of the Investigator.
- •Subject's symptoms can be reproduced with resisted supination or wrist dorsiflexion (as confirmed by tenderness at lateral epicondyle and positive pick up back of chair sign).
- •Subject's symptoms have persisted for at least 6 weeks to 9 months, despite conservative treatment that includes 1 or combinations of:
- •Physical therapy
排除标准
- •Subjects with any of the following will be excluded from study participation:
- •Subject has undergone previous corticosteroid injection therapy to the affected elbow in less than 6 months prior to enrolment.
- •Subjects unwilling or unable to discontinue use of pain medication (opiate or NSAID) from at least 1 week prior to Investigational Medicinal Product (IMP) administration.
- •Subject has received previous Platelet-Rich Plasma (PRP) injection to the affected elbow.
- •Subject uses or has recent use of medications known to affect the skeleton (e.g., glucocorticoid usage >5 mg/day, fluoroquinolone antibiotics).
- •Subject has undergone surgical intervention to the affected elbow for the treatment of lateral epicondylitis.
研究组 & 干预措施
TenoMiR intralesional injection
Drug: TenoMiR (Low Dose), Single injection Mimic of miR29a
Other Names:
• CWT-001
Drug: TenoMiR (High Dose), Single injection Mimic of miR29a
Other Names:
• CWT-001
干预措施: TenoMiR (Drug)
0.9% saline subcutaneous sham injection
Drug: 0.9% saline Subcutaneous single injection
干预措施: 0.9% Sodium Chloride Injection (Drug)
结局指标
主要结局
Numeric Rating Scale (NRS) pain score. Minimum score 0 (no pain), Maximum score 10 (worst possible pain)
时间窗: 90 days
Changes in pain score per group
次要结局
- Disabilities of the Arm, Shoulder, and Hand (QuickDASH) score. Minimum score 0 (no disability), Maximum score 100 (most severe disability)(90 days)
- American Shoulder and Elbow Surgeons Elbow (ASES-E) score. Minimum score 0 (no pain or disability), Maximum score 144 (worst pain or disability)(90 days)
- Ultrasound assessment(90 days)
- Patient Rated Tennis Elbow Evaluation (PRTEE) score. Minimum Score 0 (no pain or disability) Maximum Score 100 (worst pain and disability)(90 days)
- Ultrasound Tissue Characterisation (UTC)(90 days)
- Incidence of Treatment-Emergent Adverse Events (AEs) between TenoMiR and sham comparator(90 days)
- Single dose pharmacokinetics (PK) of TenoMiR administration in subjects with lateral epicondylitis (Cmax).(90 days)