Efficacy and Safety of TenoMiR in Lateral Epicondylitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

123 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-10

Study Completion Date

2025-06-12

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Safety, Tolerability, and Pharmacokinetics of Single Dose TenoMiR as a Treatment for Tennis Elbow

NCT04670289

Tennis Elbow

COMPLETED PHASE1

Phase II Study of the Effects of rhPDGF-BB Injection on Lateral Epicondylitis

NCT01746420

Lateral Epicondylitis

COMPLETED PHASE2

Diclofenac Patch for Treatment of Mild to Moderate Tendonitis or Bursitis

NCT00640939

Rotator Cuff Tendonitis Bicipital Tendonitis Subdeltoid Bursitis of the Shoulder +4 more

COMPLETED PHASE2/PHASE3

Study to Evaluate the Efficacy of the Synera Patch Compared to Naproxen Sodium for Epicondylitis of the Elbow

NCT01525043

Epicondylitis of the Elbow

COMPLETED PHASE4

Tanezumab In Osteoarthritis Of The Hip Or Knee

NCT00985621

Osteoarthritis

TERMINATED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Tennis Elbow

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type EXPERIMENTAL

TenoMiR

Intervention Type DRUG

Single intralesional injection

0.9% saline subcutaneous sham injection

Drug: 0.9% saline Subcutaneous single injection

Group Type SHAM_COMPARATOR

0.9% Sodium Chloride Injection

Intervention Type DRUG

Single subcutaneous injection

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

TenoMiR

Single intralesional injection

Intervention Type DRUG

0.9% Sodium Chloride Injection

Single subcutaneous injection

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

CWT-001

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No