Efficacy and Safety of TenoMiR in Lateral Epicondylitis

NCT06192927 | Completed Phase 2 FDA Drug

• 1 other identifier: CWT-TE2
• Study Type: interventional
• Target: 123
• Locations: 2 countries
• Sites: 9

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.

Conditions

Tennis Elbow

Outcome Measures

Primary Outcomes (1)

• Numeric Rating Scale (NRS) pain score. Minimum score 0 (no pain), Maximum score 10 (worst possible pain)

  Changes in pain score per group

  90 days

Secondary Outcomes (7)

• Disabilities of the Arm, Shoulder, and Hand (QuickDASH) score. Minimum score 0 (no disability), Maximum score 100 (most severe disability)

  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

• 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

• Ultrasound Tissue Characterisation (UTC)

  90 days

Study Arms (2)

TenoMiR intralesional injection

EXPERIMENTAL

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

0.9% saline subcutaneous sham injection

SHAM COMPARATOR

Drug: 0.9% saline Subcutaneous single injection

Drug: 0.9% Sodium Chloride Injection

Interventions

TenoMiR DRUG

Single intralesional injection

Also known as: CWT-001

TenoMiR intralesional injection

0.9% Sodium Chloride Injection DRUG

Single subcutaneous injection

0.9% saline subcutaneous sham injection

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Splinting
• NSAIDs

You may not qualify if:

• 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.

Sponsors & Collaborators

• Causeway Therapeutics: lead

Study Sites (9)

Stanford Medicine

Redwood City, California, 94063, United States

Location

Hospital for Special Surgery

New York, New York, 10021, United States

Location

NYU Langone Health

New York, New York, 10022, United States

Location

Panthera Biopartners

Enfield, EN3 4GS, United Kingdom

Location

Panthera Biopartners

Glasgow, G51 4TY, United Kingdom

Location

Glasgow Clinical Research Facility

Glasgow, United Kingdom

Location

Panthera Biopartners

Preston, PR2 9QB, United Kingdom

Location

Panthera Biopartners

Rochdale, OL11 4AU, United Kingdom

Location

Panthera Biopartners

Sheffield, S2 5FX, United Kingdom

Location

MeSH Terms

Conditions

Tennis Elbow

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Elbow Tendinopathy; Tendinopathy; Muscular Diseases; Musculoskeletal Diseases; Elbow Injuries; Arm Injuries; Wounds and Injuries; Tendon Injuries

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2023
• First Posted: January 5, 2024
• Study Start: April 10, 2024
• Primary Completion: March 3, 2025
• Study Completion: June 12, 2025
• Last Updated: August 1, 2025

Record last verified: 2025-07

Locations

US (3); GB (6)