Efficacy and Safety of TenoMiR in Lateral Epicondylitis

April 19, 2024 updated by: Causeway Therapeutics

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 6 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Drug: TenoMiR
Single intralesional injection
Other Names:
  • CWT-001
Sham Comparator: 0.9% saline subcutaneous sham injection
Drug: 0.9% saline Subcutaneous single injection
Drug: 0.9% Sodium Chloride Injection
Single subcutaneous injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Numeric Rating Scale (NRS) pain score. Minimum score 0 (no pain), Maximum score 10 (worst possible pain)
Time Frame: 90 days
Changes in pain score per group
90 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Single dose pharmacokinetics (PK) of TenoMiR administration in subjects with lateral epicondylitis (Cmax).
Time Frame: 90 days
Plasma PK by maximum drug plasma concentration (Cmax).
90 days
Disabilities of the Arm, Shoulder, and Hand (QuickDASH) score. Minimum score 0 (no disability), Maximum score 100 (most severe disability)
Time Frame: 90 days
Changes in QuickDASH per group
90 days
Patient Rated Tennis Elbow Evaluation (PRTEE) score. Minimum Score 0 (no pain or disability) Maximum Score 100 (worst pain and disability)
Time Frame: 90 days
Changes in PRTEE per group
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)
Time Frame: 90 days
Changes in ASES-E per group
90 days
Ultrasound assessment
Time Frame: 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.
90 days
Ultrasound Tissue Characterisation (UTC)
Time Frame: 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).
90 days
Incidence of Treatment-Emergent Adverse Events (AEs) between TenoMiR and sham comparator
Time Frame: 90 days
Comparison of safety data between groups
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Causeway Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 10, 2024

Primary Completion (Estimated)

September 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

November 28, 2023

First Submitted That Met QC Criteria

December 20, 2023

First Posted (Actual)

January 5, 2024

Study Record Updates

Last Update Posted (Actual)

April 22, 2024

Last Update Submitted That Met QC Criteria

April 19, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CWT-TE2

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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