Clinical trial NCT04670289: Safety, Tolerability, and Pharmacokinetics of Single Dose TenoMiR as a Treatment for Tennis Elbow
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Tennis Elbow
Lead sponsor: Causeway Therapeutics
Sponsor class: INDUSTRY
First posted: 2020-12-17
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, Controlled, Randomised, Double Blind, Single Centre Trial
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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 re-tested 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.

Primary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events (AEs) as assessed by comparison of clinical laboratory abnormalities between TenoMiR versus placebo.
timeFrame: 14 days
measure: Incidence of Treatment-Emergent Adverse Events (AEs) as assessed by comparison of changes in vital signs between TenoMiR versus placebo.
timeFrame: 14 days
measure: Incidence of Treatment-Emergent Adverse Events (AEs) as assessed by comparison of changes in 12 lead ECG parameters between TenoMiR versus placebo.
timeFrame: 14 days
measure: Incidence of Treatment-Emergent Adverse Events (AEs) as assessed by comparison of physical examination between TenoMiR versus placebo.
timeFrame: 14 days
measure: Incidence of Treatment-Emergent Adverse Events (AEs) as assessed by comparison of skin score assessment between TenoMiR versus placebo.
timeFrame: 14 days
Secondary outcomes:
measure: Single dose pharmacokinetics (PK) of TenoMiR administration in subjects with lateral epicondylitis (Cmax).
timeFrame: 90 days
measure: Single dose pharmacokinetics (PK) of TenoMiR administration in subjects with lateral epicondylitis (tmax).
timeFrame: 90 days
measure: Single dose pharmacokinetics (PK) of TenoMiR administration in subjects with lateral epicondylitis (AUC).
timeFrame: 90 days
measure: Visual Analogue Score (VAS) pain score
timeFrame: 90 days
measure: Disabilities of the Arm, Shoulder, and Hand (Quick DASH) score
timeFrame: 90 days
measure: American Shoulder and Elbow Surgeons Elbow (ASES-E) score
timeFrame: 90 days
measure: Patient Rated Tennis Elbow Evaluation (PRTEE) score
timeFrame: 90 days
measure: Ultrasound assessment
timeFrame: 90 days
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: MAC Clinical Research
Study officials:
References: