Tennis Elbow
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGTenoMiR
Single intralesional injection
DRUG0.9% Sodium Chloride Injection
Single subcutaneous injection
Sponsors
Causeway Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Subjects must meet all of the following inclusion criteria. 1. Subject has a clinical diagnosis of lateral epicondylitis. 2. 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. 3. 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). 4. Subject's symptoms have persisted for at least 6 weeks to 9 months, despite conservative treatment that includes 1 or combinations of: 1. Physical therapy 2. Splinting 3. NSAIDs
Exclusion criteria
Subjects with any of the following will be excluded from study participation: 1. Subject has undergone previous corticosteroid injection therapy to the affected elbow in less than 6 months prior to enrolment. 2. 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. 3. Subject has received previous Platelet-Rich Plasma (PRP) injection to the affected elbow. 4. Subject uses or has recent use of medications known to affect the skeleton (e.g., glucocorticoid usage \>5 mg/day, fluoroquinolone antibiotics). 5. Subject has undergone surgical intervention to the affected elbow for the treatment of lateral epicondylitis.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Numeric Rating Scale (NRS) pain score. Minimum score 0 (no pain), Maximum score 10 (worst possible pain) | 90 days | Changes in pain score per group |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Rated Tennis Elbow Evaluation (PRTEE) score. Minimum Score 0 (no pain or disability) Maximum Score 100 (worst pain and disability) | 90 days | Changes in PRTEE per group |
| 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 | Changes in ASES-E per group |
| Ultrasound assessment | 90 days | Change in analysis of focal hypoechoic areas within the tendon per group. Evaluation will performed using a standardized scoring form (0=normal tendon, 1= mild tendinopathy, 2=moderate tendinopathy and 3= severe tendinopathy). Echogenicity will be characterized as hypoechogenic, normal, or hyperechogenic. Swelling (present or not present) of the tendon itself will be evaluated. Tendon thickness in mm will be noted. Calcifications (present or not present) will be assessed. |
| Disabilities of the Arm, Shoulder, and Hand (QuickDASH) score. Minimum score 0 (no disability), Maximum score 100 (most severe disability) | 90 days | Changes in QuickDASH per group |
| Incidence of Treatment-Emergent Adverse Events (AEs) between TenoMiR and sham comparator | 90 days | Comparison of safety data between groups |
| Single dose pharmacokinetics (PK) of TenoMiR administration in subjects with lateral epicondylitis (Cmax). | 90 days | Plasma PK by maximum drug plasma concentration (Cmax). |
| Ultrasound Tissue Characterisation (UTC) | 90 days | Change in analysis of collagen echotypes within the tendon per group. Evaluation will be performed using the UTC system to objectively quantify greyscale tendon matrix changes into 4 different echotypes related to tendon integrity. Types I and II represent an organised matrix; Types III and IV represent a disorganised matrix. The composition of the tendon between groups will be assessed using the 4 listed echotypes. In addition, change between groups will be assessed by 3-dimensional ultrasound image of the tendon using standardised parameters (transducer tilt angle, depth and gain settings). |
Countries
United Kingdom, United States
Outcome results
None listed