Tennis ElbowPhase 1NCT04670289
Safety, Tolerability, and Pharmacokinetics of Single Dose TenoMiR as a Treatment for Tennis Elbow
A Phase 1 study testing TenoMiR (Low Dose), TenoMiR (Medium Dose) and TenoMiR (High Dose) in people with Tennis Elbow, run by Causeway Therapeutics at 1 site in United Kingdom.
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 70 years
- Conditions the study is for
- Tennis Elbow
- What is being tested?
- TenoMiR (Low Dose), TenoMiR (Medium Dose) and TenoMiR (High Dose)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 14 Aug 2020to 18 Aug 2021
- Phase
- Phase 1
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 re-tested 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 6 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
1 site in 1 country.
About this study
Official title: A Phase 1, Single-Centre, Randomised, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability and Pharmacokinetics of Single Ascending Doses of TenoMiR Injections 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.
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.
- Conditions
- Tennis Elbow
- Being tested
- TenoMiR (Low Dose), TenoMiR (Medium Dose), TenoMiR (High Dose), Placebo
- Medical subject headings
- Tennis Elbow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TenoMiR (Low Dose)Drug
Also called CWT-001
Mimic of miR29a
TenoMiR (Medium Dose)Drug
Also called CWT-001
Mimic of miR29a
TenoMiR (High Dose)Drug
Also called CWT-001
Mimic of miR29a
PlaceboDrug
0.9% saline
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | TenoMiR intralesional injection Receives: Drug: TenoMiR (Low Dose); Drug: TenoMiR (Medium Dose); Drug: TenoMiR (High Dose) |
| Placebo | Placebo comparator | 0.9% saline intralesional injection Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events (AEs) as assessed by comparison of clinical laboratory abnormalities between TenoMiR versus placebo.
Comparison of clinical laboratory abnormalities between TenoMiR versus placebo as measured by blood chemistry, haematology, coagulation, serology and urinalysis.
Measured: 14 days
Incidence of Treatment-Emergent Adverse Events (AEs) as assessed by comparison of changes in vital signs between TenoMiR versus placebo.
Comparison of changes in vital signs between TenoMiR versus placebo as measured by supine vital signs including pulse rate, blood pressure, respiration rate and oral temperature.
Measured: 14 days
Incidence of Treatment-Emergent Adverse Events (AEs) as assessed by comparison of changes in 12 lead ECG parameters between TenoMiR versus placebo.
Comparison of changes in 12 lead ECG parameters as measured by Heart Rate and PR, RR, QRS, QT and QT intervals.
Measured: 14 days
Incidence of Treatment-Emergent Adverse Events (AEs) as assessed by comparison of physical examination between TenoMiR versus placebo.
Comparison of changes in physical examination between TenoMiR versus placebo as measured by height, BMI, and body weight, and assessments of the head, eyes, ears, nose, throat, skin, thyroid, neurological, lungs, cardiovascular system, abdomen (liver and spleen), lymph nodes and extremities.
Measured: 14 days
Incidence of Treatment-Emergent Adverse Events (AEs) as assessed by comparison of skin score assessment between TenoMiR versus placebo.
Comparison of changes in skin score assessment of injection site between TenoMiR versus placebo as measured by for erythema, pain, tenderness and swelling.
Measured: 14 days
Secondary outcomes (8)
Single dose pharmacokinetics (PK) of TenoMiR administration in subjects with lateral epicondylitis (Cmax).
Plasma PK by maximum drug plasma concentration (Cmax).
Measured: 90 days
Single dose pharmacokinetics (PK) of TenoMiR administration in subjects with lateral epicondylitis (tmax).
Plasma PK by time to reach Cmax (tmax).
Measured: 90 days
Single dose pharmacokinetics (PK) of TenoMiR administration in subjects with lateral epicondylitis (AUC).
Plasma PK by area under the plasma vs. concentration time curve (AUC).
Measured: 90 days
Visual Analogue Score (VAS) pain score
Changes in pain score per group
Measured: 90 days
Disabilities of the Arm, Shoulder, and Hand (Quick DASH) score
Changes in Quick DASH per group
Measured: 90 days
American Shoulder and Elbow Surgeons Elbow (ASES-E) score
Changes in ASES-E per group
Measured: 90 days
Patient Rated Tennis Elbow Evaluation (PRTEE) score
Changes in PRTEE per group
Measured: 90 days
Ultrasound assessment
Change in analysis of focal hypoechoic areas within the tendon per group
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 posted17 Dec 2020
- Study start14 Aug 2020
- Primary completion19 May 2021
- Study completion18 Aug 2021
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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, Controlled, Randomised, Double Blind, Single Centre Trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 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
- NCT04670289
- Sponsor's protocol ID
- CWT-TE1
- Status last verified
- Sep 2021
- First submitted
- 26 Nov 2020
- Last updated
- 17 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Single-Centre, Randomised, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability and Pharmacokinetics of Single Ascending Doses of TenoMiR Injections in Subjects With Lateral Epicondylitis
- ClinicalTrials.gov ID
- NCT04670289
- Acronym / sponsor ID
- CWT-TE1
- Conditions
- Tennis Elbow
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Causeway TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 14 Aug 2020 (actual)
- Primary completion
- 19 May 2021 (actual)
- Study completion
- 18 Aug 2021 (actual)
- First posted
- 17 Dec 2020 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Prospective, Controlled, Randomised, Double Blind, Single Centre Trial
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: TenoMiR (Low Dose), Drug: TenoMiR (Medium Dose), Drug: TenoMiR (High Dose)TenoMiR intralesional injection |
| Placebo | Placebo comparator | Drug: Placebo0.9% saline intralesional injection |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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 re-tested 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 6 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 |
|---|---|---|
| TenoMiR (Low Dose)Also: CWT-001Mimic of miR29a | Drug | Treatment |
| TenoMiR (Medium Dose)Also: CWT-001Mimic of miR29a | Drug | Treatment |
| TenoMiR (High Dose)Also: CWT-001Mimic of miR29a | Drug | Treatment |
| Placebo0.9% saline | Drug | Placebo |
Primary outcome
Incidence of Treatment-Emergent Adverse Events (AEs) as assessed by comparison of clinical laboratory abnormalities between TenoMiR versus placebo.
Time frame: 14 days
Comparison of clinical laboratory abnormalities between TenoMiR versus placebo as measured by blood chemistry, haematology, coagulation, serology and urinalysis.
Incidence of Treatment-Emergent Adverse Events (AEs) as assessed by comparison of changes in vital signs between TenoMiR versus placebo.
Time frame: 14 days
Comparison of changes in vital signs between TenoMiR versus placebo as measured by supine vital signs including pulse rate, blood pressure, respiration rate and oral temperature.
Incidence of Treatment-Emergent Adverse Events (AEs) as assessed by comparison of changes in 12 lead ECG parameters between TenoMiR versus placebo.
Time frame: 14 days
Comparison of changes in 12 lead ECG parameters as measured by Heart Rate and PR, RR, QRS, QT and QT intervals.
Incidence of Treatment-Emergent Adverse Events (AEs) as assessed by comparison of physical examination between TenoMiR versus placebo.
Time frame: 14 days
Comparison of changes in physical examination between TenoMiR versus placebo as measured by height, BMI, and body weight, and assessments of the head, eyes, ears, nose, throat, skin, thyroid, neurological, lungs, cardiovascular system, abdomen (liver and spleen), lymph nodes and extremities.
Incidence of Treatment-Emergent Adverse Events (AEs) as assessed by comparison of skin score assessment between TenoMiR versus placebo.
Time frame: 14 days
Comparison of changes in skin score assessment of injection site between TenoMiR versus placebo as measured by for erythema, pain, tenderness and swelling.
8 secondary outcomes
Single dose pharmacokinetics (PK) of TenoMiR administration in subjects with lateral epicondylitis (Cmax).
Time frame: 90 days
Single dose pharmacokinetics (PK) of TenoMiR administration in subjects with lateral epicondylitis (tmax).
Time frame: 90 days
Single dose pharmacokinetics (PK) of TenoMiR administration in subjects with lateral epicondylitis (AUC).
Time frame: 90 days
Visual Analogue Score (VAS) pain score
Time frame: 90 days
Disabilities of the Arm, Shoulder, and Hand (Quick DASH) score
Time frame: 90 days
American Shoulder and Elbow Surgeons Elbow (ASES-E) score
Time frame: 90 days
Patient Rated Tennis Elbow Evaluation (PRTEE) score
Time frame: 90 days
Ultrasound assessment
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 17 Sep 2021.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TenoMiR (Low Dose), TenoMiR (Medium Dose) and TenoMiR (High Dose) in people with Tennis Elbow, run by Causeway Therapeutics at 1 site in United Kingdom.
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 7 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 17 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Incidence of Treatment-Emergent Adverse Events (AEs) as assessed by comparison of clinical laboratory abnormalities between TenoMiR versus placebo. (time frame: 14 days). The study lists 5 primary outcomes in all. 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 17 Sep 2021; AzTrials last refreshed its copy on 8 Nov 2026.