Tennis ElbowPhase 2NCT06192927
Efficacy and Safety of TenoMiR in Lateral Epicondylitis
A Phase 2 study testing TenoMiR and 0.9% Sodium Chloride Injection in people with Tennis Elbow, run by Causeway Therapeutics at 9 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Tennis Elbow
- What is being tested?
- TenoMiR and 0.9% Sodium Chloride Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 123 participants
- Where
- 9 sitesin 2 countries
- Study dates
- 10 Apr 2024to 12 Jun 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Splinting
- NSAIDs
Who cannot join
- 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.
Trial locations and contacts
9 sites in 2 countries.
9 sites in 2 countries
United Kingdom6 sites
Panthera Biopartners
Enfield, EN3 4GS
Panthera Biopartners
Glasgow, G51 4TY
Glasgow Clinical Research Facility
Glasgow
Panthera Biopartners
Preston, PR2 9QB
Panthera Biopartners
Rochdale, OL11 4AU
Panthera Biopartners
Sheffield, S2 5FX
United States3 sites
Hospital for Special Surgery
New York, New York, 10021
NYU Langone Health
New York, New York, 10022
Stanford Medicine
Redwood City, California, 94063
About this study
Official title: 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.
Read the 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.
- Conditions
- Tennis Elbow
- Being tested
- TenoMiR, 0.9% Sodium Chloride Injection
- Medical subject headings
- Tennis Elbow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TenoMiRDrug
Also called CWT-001
Single intralesional injection
0.9% Sodium Chloride InjectionDrug
Single subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: TenoMiR |
| 0.9% saline subcutaneous sham injection | Sham comparator | Drug: 0.9% saline Subcutaneous single injection Receives: Drug: 0.9% Sodium Chloride Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Rating Scale (NRS) pain score. Minimum score 0 (no pain), Maximum score 10 (worst possible pain)
Changes in pain score per group
Measured: 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)
Changes in QuickDASH per group
Measured: 90 days
Patient Rated Tennis Elbow Evaluation (PRTEE) score. Minimum Score 0 (no pain or disability) Maximum Score 100 (worst pain and disability)
Changes in PRTEE per group
Measured: 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)
Changes in ASES-E per group
Measured: 90 days
Ultrasound assessment
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.
Measured: 90 days
Ultrasound Tissue Characterisation (UTC)
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).
Measured: 90 days
Incidence of Treatment-Emergent Adverse Events (AEs) between TenoMiR and sham comparator
Comparison of safety data between groups
Measured: 90 days
Single dose pharmacokinetics (PK) of TenoMiR administration in subjects with lateral epicondylitis (Cmax).
Plasma PK by maximum drug plasma concentration (Cmax).
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start10 Apr 2024
- Primary completion3 Mar 2025
- Study completion12 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tennis ElbowStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Causeway Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06192927
- Sponsor's protocol ID
- CWT-TE2
- Status last verified
- Jul 2025
- First submitted
- 28 Nov 2023
- Last updated
- 1 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06192927
- Acronym / sponsor ID
- CWT-TE2
- Conditions
- Tennis Elbow
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- Causeway TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 10 Apr 2024 (actual)
- Primary completion
- 3 Mar 2025 (actual)
- Study completion
- 12 Jun 2025 (actual)
- First posted
- 5 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TenoMiR intralesional injection | Experimental | Drug: TenoMiRDrug: 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 |
| 0.9% saline subcutaneous sham injection | Sham comparator | Drug: 0.9% Sodium Chloride InjectionDrug: 0.9% saline Subcutaneous single injection |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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:
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TenoMiRAlso: CWT-001Single intralesional injection | Drug | TenoMiR intralesional injection |
| 0.9% Sodium Chloride InjectionSingle subcutaneous injection | Drug | 0.9% saline subcutaneous sham injection |
Primary outcome
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
7 secondary outcomes
Disabilities of the Arm, Shoulder, and Hand (QuickDASH) score. Minimum score 0 (no disability), Maximum score 100 (most severe disability)
Time frame: 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
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
Ultrasound assessment
Time frame: 90 days
Ultrasound Tissue Characterisation (UTC)
Time frame: 90 days
Incidence of Treatment-Emergent Adverse Events (AEs) between TenoMiR and sham comparator
Time frame: 90 days
Single dose pharmacokinetics (PK) of TenoMiR administration in subjects with lateral epicondylitis (Cmax).
Time frame: 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TenoMiR and 0.9% Sodium Chloride Injection in people with Tennis Elbow, run by Causeway Therapeutics at 9 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United Kingdom, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric Rating Scale (NRS) pain score. Minimum score 0 (no pain), Maximum score 10 (worst possible pain) (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2025.